0% found this document useful (0 votes)

213 views43 pages

Medicamentos .PT - en

The document outlines the Regulatory Agenda for the National Health Surveillance Agency (Anvisa) for the 2024-2025 biennial cycle, focusing on the regulation of medicines. It details the responsibilities of Anvisa, including registration, inspection, and quality control of pharmaceutical products, as well as the establishment of guidelines for various types of medicines and their approval processes. The agenda aims to enhance regulatory quality and facilitate access to standards for both internal and external stakeholders.

Uploaded by

reddyalekhya74

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

0% found this document useful (0 votes)

213 views43 pages

Medicamentos .PT - en

Uploaded by

reddyalekhya74

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

You are on page 1/ 43

Translated from Portuguese to English - www.onlinedoctranslator.

com

REGULATORY AGENDA
Biennial Cycle
2024-2025

LIBRARY OF
MEDICINES
Updated on 04/17/2025

Coordination of Regulatory Processes – CPROR

Regulatory Quality Improvement Advisory – ASREG

Office of the Chief Executive Officer
PRESENTATION

Medicines represent one of the most comprehensive and prominent macro-themes at the National
Health Surveillance Agency (Anvisa).

Some of the Agency's responsibilities in the area of medicines are: registration; authorization of
operation and inspection of pharmaceutical laboratories and other companies in the pharmaceutical
chain; analysis of patent applications related to pharmaceutical products and processes; and price
regulation, through the Chamber for Regulation of the Medicines Market (CMED). Other actions are
shared with states and municipalities, such as inspection of manufacturers, quality control of
medicines and post-marketing surveillance, with emphasis on pharmacovigilance and regulation of
medicine advertising.

Libraries are documents that bring together all current standards for a given
macro-topic, divided by themes. The objective is to facilitate access and understanding of
the Regulatory Stock for internal and external audiences, as well as to improve the
process of drafting and reviewing regulations.

Be sure to also check out theLibrary of Cross-Cutting Themes, which covers subjects
applied to all macro-themes, such as: Company Operating Authorization (AFE), Good
Manufacturing Practices Certification (CBPF), Surveillance Inspection Fees
Sanitary (TFVS), Petitioning for Resources, etc.
Summary
..........................................................................................................................................................................................0

1. Regularization of Products subject to Health Surveillance .............................................................................................. 5

1.1. Registration, post-registration and notification of medicinal products (general rules) .......................................................... 5

1.2. Requirements for simplified procedure for requests for registration, post-registration and renewal of registration of
medicinal products ........................................................................................................................................................ 7

1.3. Non-Prescription Drugs (NMPs) ...................................................................................................... 7

1.4. Registration and post-registration of medicines produced through partnerships for the productive development of
strategic technologies defined by the Ministry of Health........................................................................................................ 8

1.5. Methodologies for quality control, safety and efficacy of medicines.................................................................. 8

1.6. Minimum requirements for the validation of bioanalytical methods used in studies for the purposes of drug
registration and post-registration........................................................................................................................... 10

1.7. Biowaiver for medicines ...................................................................................................................... 11

1.8. Tests of relative bioavailability/bioequivalence of drugs and preparation of a technical report on relative
bioavailability/bioequivalence studies........................................................................................................ 11

1.9. Drugs that are candidates for biowaiver ...................................................................................................................... 12

1.10. Clinical Research................................................................................................................................................... 12

1.11. Assistance Programs for Experimental Drugs .............................................................................. 14

1.12. Registration and post-registration of synthetic and semi-synthetic drugs (generics, similar and new) ......... 14

1.13. Use of analysis carried out by an Equivalent Foreign Regulatory Authority for the purposes of regularizing
products within the scope of GGMED ...................................................................................................................... 16

1.14. Regulation of Cannabis products for medicinal purposes ...................................................................................... 17

1.15. Registration and post-registration of biological products .............................................................................................. 17

1.16. Registration and post-registration of allergenic extracts and products for diagnostic or therapeutic purposes.......... 19

1.17. Registration of radiopharmaceutical products ................................................................................................................... 19

1.18. Registration and post-registration of specific drugs ...................................................................................... 19

1.19. Registration, post-registration of dynamized drugs...................................................................................... 21

1.20. Notification, registration and post-registration changes of medicinal gases classified as drugs. .... 21

1.21. Registration, notification and post-registration of herbal medicines............................................................................... 21

1.22. Quality control of herbal medicines ...................................................................................................... 22

1.23. Low-risk medicinal products subject to simplified notification ...................................................................... 22

1.24. Reference Drugs ...................................................................................................................................... 23

1.25. Quality requirements for the preparation of registration and post-registration dossiers for synthetic medicinal
products. .................................................................................................................................................................... 23

1.26. Regulations for the approval of names for medicines, their supplements and the formation of families of
medicines. ...................................................................................................................................................... 24

1.27. Requirements for demonstrating the safety and efficacy of new and innovative drugs ....................... 24

1.28. International alignment of parameters for the validation of analytical methods for medicinal products .. 25
1.29. Degradation products in drugs ...................................................................................................... 25
1.30. Risk assessment and control of potentially carcinogenic nitrosamines in medicinal products for human
use. ................................................................................................................................................................................... 25

1.31. Conditional health regularization of medicines via commitment term..................................................... 25

1.32. Health requirements for the regulation and monitoring of industrialized medicines for human use throughout
their life cycle ........................................................................................................................................................ 27

1.33. General Guidelines for the pilot implementation of the optimized assessment procedure, based on health risk in
applications for registration and post-registration of medicines .......................................................................... 28

1.34. Conditions and procedures for the registration of pre-pandemic influenza vaccines, upgrade to a
pandemic strain and authorization of use, marketing and monitoring of pandemic influenza vaccines
29
1.35. Regulation of Innovation in the Areas of Medicines and Biological Products.................................................................. 29

1.36. Commitment term for purposes of registration, post-registration or temporary authorization for emergency use of
medicines .................................................................................................................................................................... 29

1.37. Composition of seasonal influenza vaccine ........................................................................................................ 29

2. Consumer information ...................................................................................................................................... 30

2.1. Drug Information Sheet and Labeling ................................................................................................................ 30

2.2. Commercial promotion and advertising of medicines...................................................................................... 31

3. Regularization of services and establishments subject to health surveillance and Good Practices.................................... 32

3.1. Good Manufacturing Practices for Medications...................................................................................................... 32

3.2. Outsourcing of production stages, quality control analysis and storage of

medicines .............................................................................................................................................................. 33
3.3. Good Handling Practices in Pharmacies ...................................................................................................................... 33

3.4. Good Practices in Equivalence Centers ...................................................................................................... 34

3.5. Good practices for storage, distribution and transportation of medical gases............................................... 34

3.6. Good Practices for the Preparation of Radiopharmaceuticals in Health Care Facilities and Radiopharmacies............ 35

3.7. Good Clinical Practices (GCP) ................................................................................................................................ 35

3.8. Good Pharmacovigilance Practices ...................................................................................................................... 35

4. Control, inspection and monitoring of products subject to Health Surveillance .............................................. 36

4.1. Control and supervision of the drug distribution chain ...................................................................... 36

4.2. Good practices for the distribution, storage and transportation of medicines ...................................................... 37

4.3. National Medicines Control System (SNCM) .................................................................................. 37

4.4. Control of medicines and substances subject to special control .............................................................. 37

4.5. Control of medicines based on substances classified as antimicrobials, for use under prescription, subject
to specific control......................................................................................................................................... 38

4.6. Procedures for discontinuing the manufacture or import of medicines, as well as for
reactivation................................................................................................................................................................. 39

4.7. Products subject to health surveillance considered to be of traditional health use ........................................... 39
4.8. Pharmacovigilance................................................................................................................................................... 39

5. Health control in foreign trade and in ports, airports, borders and customs areas. 40
5.1. Procedures for importing/exporting medicines................................................................................... 40

5.2. Exceptional importation of medicines ...................................................................................................... 41

5.3. Procedures and format for generating the Certificate of Registration of Medication, Certificate of Registration for
Export of Medication and Authorization for Exclusive Purpose of Export (AFEX). ............................................................ 42
1. Regularization of Products subject to Health Surveillance

Law 6360/1976 - Provides for the Health Surveillance to which Medicines, Drugs, Pharmaceutical Inputs and Related
Products, Cosmetics, Disinfectants and Other Products are subject, and contains other Provisions.

DCT 8077/2013 - Regulates the conditions for the operation of companies subject to health licensing, and the
registration, control and monitoring, within the scope of health surveillance, of the products covered by Law
No. 6,360/1976.

RDC 25/2011 - general procedures for using document protocol services within the scope of Anvisa.

RDC 204/2005 - Procedure for petitions submitted for analysis by ANVISA's technical departments
Related act:
RDC 219/2018 - Guidelines for conditional approval of post-registration change petitions for medicinal
products

RDC 250/2004 - Revalidation of registration of products subject to Health Surveillance.

RDC 903/2024 - Procedures for transferring ownership of registration of products subject to health
surveillance, global transfer of responsibility for clinical trials and updating of registration data relating to
the operation and certification of companies, as a result of corporate operations or commercial
transactions.

RDC 911/2024 - Possibility of admitting the submission of documents in an administrative appeal against
a decision that rejects a request for renewal of drug registration.

1.1. Registration, post-registration and notification of medicinal products (general rules)

RDC 59/2014 – Names of medicines, their supplements and the formation of families of medicines for
simplified registration.

RDC 2/2012 - Electronic protocol for issuing a registration certificate and a registration certificate for
exporting medicines.

RDC 18/2014 – Mandatory communication to ANVISA of cases of temporary and permanent

discontinuation of the manufacture or import of medicines, as well as the reactivation of the manufacture
or import of medicines.
Related topic:Procedures for discontinuing the manufacture or import of medicines, as well as
for reactivation

RDC 204/2017 - Classification in the priority category of registration, post-registration and prior approval
petitions in clinical research of medicines.
Changed by:
RDC 811/2023

RDC 205/2017 - Establishes a special procedure for approval of clinical trials, certification of good
manufacturing practices and registration of new medicines for the treatment, diagnosis or prevention of
rare diseases.
Changed by:
RDC 293/2019
RDC 406/2020
RDC 763/2022
RDC 811/2023

RE 1/2002 - Maintain the ban on the presence of ethanol in all fortifying products, appetite and
growth stimulants, and iron supplements as set out in RE 543/2001.
Changed by:
RDC 770/2022

Guide No. 3, version 1, dated 10/07/2015 - Guide to Outcomes for clinical studies of oncology drugs.

RDC 305/2002 – Prohibition of entry and commercialization of raw materials and finished products obtained from
from tissues/fluids of ruminant animals.
Related act:
RDC 68/2003 - Establishes conditions for the import, marketing and exposure to consumption of
products included in RDC 305/2002.
Changed by:
RDC 208/2018

RDC 219/2018 - Guidelines for conditional approval of post-registration change petitions for
medicines.

RDC 615/2022- Revocation of rules below the Decree issued by the National Surveillance Agency
Sanitary - ANVISA, components of the fifth stage of consolidation, Thematic relevance MEDICINES of
competence of the organizational unit responsible for the regulation of active pharmaceutical ingredients,
medicines and biological products, in compliance with the provisions of Ordinance No. 488/GADIP-DP/ANVISA,
of September 23, 2021 and Decree No. 10,139 of November 28, 2019.

RDC 638/2022- Classification of products containing menthol as medicines, health products or

personal hygiene products, cosmetics and perfumes.

RDC 675/2022- Suitability of already registered medicines.

RDC 710/2022- Improvement of legislative technique and revocation of norms inferior to Decree issued by
National Health Surveillance Agency - ANVISA, components of the fifth stage of consolidation, Relevances
MEDICINES themes in compliance with the provisions of Ordinance No. 488/GADIP-DP/ANVISA, of 23
September 2021 and Decree No. 10,139 of November 28, 2019.
Changed by:
RDC 911/2024
RDC 913/2024
IN 319/2024

RDC 718/2022- Registration, changes and revalidations of registration of probiotic medicines.

Changed by:
RDC 912/2024
RDC 948/2024

RDC 721/2022- Registration, renewal of registration, post-registration changes and notification of medicinal products
industrialized dynamized.
Changed by:
RDC 912/2024
RDC 948/2024
RDC 731/2022- Improvement of legislative technique and revocation of norms inferior to Decree issued by
National Health Surveillance Agency - ANVISA, components of the fifth consolidation stage,
Thematic relevance(s) MEDICINES in compliance with the provisions of Ordinance No. 488/GADIP-DP/ANVISA,
of September 23, 2021 and Decree No. 10,139 of November 28, 2019.
Changed by:
RDC 912/2024

RDC 802/2023 - Pharmaceutical inputs for restricted or prohibited use in medicines for human use.

RDC 882/2024 - Criteria and procedures for classifying medicines as non-prescription and
reclassifying them as prescription medicines.

RDC 910/2024 - Bank of Ad hoc Medicines Consultants.

RDC 911/2024 - Possibility of admitting the submission of documents in an administrative appeal against
a decision that rejects a request for renewal of drug registration.

RDC 912/2024 - Expiration dates and documentation required to maintain medication regularization.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

RDC 954/2024 - Simplified procedure for requests for registration, post-registration and renewal of drug
registration and other provisions. Art. 32 of this Resolution shall come into force on June 22, 2025. (Art. 33).

Changed by:
RDC 960/2025

RDC 955/2024 - Rules for establishing Brazilian Common Denominations - DCB and for updating the list of
approved DCBs.This standard belongs to the Pharmacopoeia Library .
Related act:
IN 342/2024 - Approves the List of Brazilian Common Names - DCB of the Brazilian Pharmacopoeia. This
standard belongs to the Pharmacopoeia Library .

1.2. Requirements for simplified procedure for requests for registration, post-registration and
renewal of registration of medicinal products

Regulatory Theme 8.23 of the 2024/2025 Regulatory Agenda.

RDC 912/2024 - Expiration dates and documentation required to maintain medication regularization.

Changed by:
RDC 960/2025

1.3. Non-Prescription Drugs (NMP)

Regulatory Theme 8.44 of the 2024/2025 Regulatory Agenda: Periodic update of the list of
Non-Prescription Medicines (LMIP).

RDC 675/2022- Suitability of already registered medicines.

IN 285/2024 - List of Non-Prescription Medicines.

RDC 882/2024 - Criteria and procedures for classifying medicines as non-prescription and
reclassifying them as prescription medicines.

1.4. Registration and post-registration of medicines produced through partnerships

for the productive development of strategic technologies defined by the
Ministry of Health

RDC 02/2011 - Procedures within the scope of ANVISA for monitoring, instruction and analysis of the
registration and post-registration processes in Brazil of medicines produced through public-public or public-
private partnerships and technology transfer of interest to the Unified Health System.
Changed by:
RDC 4/2015

RDC 909/2024 - Procedures within the scope of the National Health Surveillance Agency (Anvisa) for the registration
of products in the development process or technology transfer process that are the object of public-public or public-
private Productive Development Partnerships of interest to the Unified Health System.

Changed by:
RDC 960/2025

1.5.Methodologies for quality control, safety and efficacy of medicines

Regulatory Theme 8.9 of the 2024/2025 Regulatory Agenda: Implementation of e-CTD – To be regulated.

RDC 124/2002 – Approves list of Guides that assist in procedures for controlling the quality, safety and
efficacy of medicines

RDC 31/2010 – Carrying out Pharmaceutical Equivalence and Comparative Dissolution Profile Studies
Changed by:
RDC 166/2017
RDC 742/2022
RDC 749/2022

RE 894/2003 - Guide to protocol and technical report for bioequivalence studies

RE 895/2003 - Guide for preparing a technical report on relative bioavailability/bioequivalence

studies.

Guide No. 3, version 1, dated 10/07/2015 - Guide to Outcomes for clinical studies of oncology drugs.

RDC 67/2014 - Suspension of RDC No. 61, of October 10, 2014, which deals with the linking of drug
registration to the Price Information Document protocol at the Executive Secretariat of the Drug
Market Regulation Chamber - SCMED.

RDC 35/2015 – Acceptance of alternative animal experimentation methods recognized by the National Council
for the Control of Animal Experimentation (CONCEA)

RDC 511/2021- Admissibility of foreign pharmaceutical codes.

RDC 278/2019 - Tests to prove therapeutic equivalence for oral inhaled drugs and nasal sprays and
aerosols.
Changed by:
RDC 710/2022
RDC 749/2022

IN 33/2019 - In vitro performance tests of nasal and oral inhaled drugs, in accordance with RDC No.
278/2019, relating to tests to prove the therapeutic equivalence of these drugs.
Changed by:
RDC 710/2022

Guide 24 version 1 2019 – Guide for organizing the Common Technical Document (CTD) for the registration and post-
registration of medicines.

RDC 318/2019 - Criteria for carrying out Stability Studies of active pharmaceutical ingredients and
medicines, except biologicals.
Changed by:
RDC 731/2022

Guide 28 version 1 2019 - Stability Study Guide.

RDC 636/2022- Minimum requirements for granting and canceling the adoption of parametric release in
replacement of the sterility test with Anvisa.

RDC 675/2022- Suitability of already registered medicines.

RDC 677/2022- Risk assessment and control of potentially carcinogenic nitrosamines in inputs
Active Pharmaceutical Ingredients (API) and medicines for human use.

Guide No. 50, version 4, dated 07/31/2024 - Guide on Nitrosamine Control in Pharmaceutical Inputs
Assets and Medicines.

RDC 731/2022- Improvement of legislative technique and revocation of norms inferior to Decree issued by
National Health Surveillance Agency - ANVISA, components of the fifth consolidation stage,
Thematic relevance(s) MEDICINES in compliance with the provisions of Ordinance No. 488/GADIP-DP/ANVISA,
of September 23, 2021 and Decree No. 10,139 of November 28, 2019.
Changed by:
RDC 912/2024

IN 158/2022- Production of pilot batches of medicines.

RDC 742/2022- W criteria for conducting relative bioavailability/bioequivalence (BD/BE) studies and
pharmacokinetic studies.
Changed by:
RDC 931/2024
RDC 942/2024
Related acts:
IN 327/2024
IN 328/2024
IN 329/2024

RDC 749/2022- Exemption from bioequivalence/relative bioavailability studies.

Related acts:
IN 182/2022
IN 183/2022

IN 182/2022- Validation and permeability tests with Caco-2 cells.

IN 183/2022 - List of oral drugs intended for local action in the gastrointestinal tract that are candidates for
bioexemption, as provided for in item VI of art. 7 of the Collegiate Board Resolution - RDC No. 749, 5th
September 2022.

IN 258/2023- List of qualified impurities and their respective limits.

Changed by:
IN 337/2024

RDC 912/2024 - Expiration dates and documentation required to maintain medication regularization.

IN 327/2024 - Pharmacodynamic study to prove the bioequivalence of topical dermatological

corticosteroids, in accordance with the Collegiate Board Resolution - RDC No. 742, of August 10, 2022.
IN 328/2024 - Bioequivalence studies for transdermal patches containing rivastigmine, under the terms of the
Collegiate Board Resolution - RDC No. 742, of August 10, 2022.

IN 329/2024 - List of administration forms and analytes to be quantified in relative bioavailability/

bioequivalence (BD/BE) studies and pharmacokinetic studies for immediate-release pharmaceutical
forms.

RDC 940/2024 – Approves the Brazilian Pharmacopoeia, 7th edition.

RDC 941/2024 - Validation of bioanalytical methods and analysis of study samples for regulatory
submissions of industrialized drugs for human use.

RDC 964/2025 - General requirements for carrying out Forced Degradation Studies on medicines containing
synthetic and semi-synthetic active pharmaceutical ingredients and parameters for the notification,
identification and qualification of degradation products in these same products.

RDC 821/2023- Amends RDC 53/2015 which was revoked by RDC 964/2025.

GUIDE 4_version 1_2015 - Guide for obtaining the degradation profile, and identification and qualification of
degradation products in medicines.

1.6. Minimum requirements for the validation of bioanalytical methods used in studies for
the purposes of drug registration and post-registration

RDC 941/2024 - Validation of bioanalytical methods and analysis of study samples for regulatory
submissions of industrialized drugs for human use.
Guide No. 72, version 1, dated 04/01/2024 - Guide for validation of bioanalytical methods and analysis of study
samples for regulatory submissions of industrialized drugs for human use.

1.7. Biowaiver for medicines

RDC 675/2022- Suitability of already registered medicines.

RDC 749/2022- Exemption from bioequivalence/relative bioavailability studies.

Related acts:
IN 182/2022
IN 183/2022

IN 182/2022- Validation and permeability tests with Caco-2 cells.

IN 327/2024 - Pharmacodynamic study to prove the bioequivalence of topical dermatological

corticosteroids, in accordance with the Collegiate Board Resolution - RDC No. 742, of August 10, 2022.

IN 328/2024 - Bioequivalence studies for transdermal patches containing rivastigmine, under the terms of the
Collegiate Board Resolution - RDC No. 742, of August 10, 2022.

IN 329/2024 - List of administration forms and analytes to be quantified in relative bioavailability/

bioequivalence (BD/BE) studies and pharmacokinetic studies for immediate-release pharmaceutical
forms.

1.8. Tests of relative bioavailability/bioequivalence of drugs and preparation of

a technical report on relative bioavailability/bioequivalence studies

IN 327/2024 - Pharmacodynamic study to prove the bioequivalence of topical dermatological

IN 329/2024 - List of administration forms and analytes to be quantified in relative bioavailability/

bioequivalence (BD/BE) studies and pharmacokinetic studies for immediate-release pharmaceutical
forms.

1.9. Drugs that are candidates for biowaiver

RDC 675/2022- Suitability of already registered medicines.

RDC 749/2022- Exemption from bioequivalence/relative bioavailability studies.

Related acts:
IN 182/2022
IN 183/2022

IN 182/2022- Validation and permeability tests with Caco-2 cells.

IN 327/2024 - Pharmacodynamic study to prove the bioequivalence of topical dermatological

IN 329/2024 - List of administration forms and analytes to be quantified in relative bioavailability/

bioequivalence (BD/BE) studies and pharmacokinetic studies for immediate-release pharmaceutical
forms.

1.10. Clinical Research

Regulatory Theme 8.32 of the 2024/2025 Regulatory Agenda: Review of the Regulation for
conducting clinical trials with medicines in Brazil (Revision of RDC 9/2015).

Regulatory Theme 8.35 of the 2024/2025 Regulatory Agenda: Review of the criteria for classification in
the priority category of petitions for registration, post-registration and prior consent in clinical
research of medicines, according to public relevance (Review of RDC 204/2017 and RDC 205/2017).

Regulatory Theme 8.46 of the 2024/2025 Regulatory Agenda: Update on clinical research into advanced
therapy products, in light of the publication of Law No. 14,874/2024 (Revision of RDC No. 506/2021).
RDC 38/2013 - Expanded access, compassionate use and post-study drug provision programs.
Changed by:
RDC 311/2019

Guide for Conducting Nonclinical Toxicology and Pharmacological Safety Studies Required for Drug
Development - Version 2

Guide No. 3, version 1, dated 10/07/2015 - Guide to Outcomes for clinical studies of oncology drugs.

Guide No. 27, version 1, dated 08/26/2019 - Non-clinical Evaluation for Anticancer Pharmaceutical Products.

Guide No. 35, version 2, dated 01/26/2022 - Inspection guide in Good Clinical Practices (GCP) regarding clinical
trials with medicines and biological products - Inspection in Clinical Trial Centers.

Guide No. 36, version 2, dated 01/26/2022 - Inspection guide in Good Clinical Practices (GCP) regarding
clinical trials with medicines and biological products - Inspection of Sponsors and Clinical Research
Representative Organizations (CRPO).

RDC 172/2017 - Procedures for the import and export of goods and products intended for scientific or
technological research and research involving human beings, and other provisions.

RDC 204/2017 - Classification in the priority category of registration, post-registration and prior approval
petitions in clinical research of medicines.
Changed by:
RDC 811/2023

RDC 506/2021- Rules for conducting clinical trials with investigational advanced therapy products
in Brazil.
Changed by:
IN 270/2023

IN 122/2022- Inspection procedures in Good Clinical Practices for clinical trials with medicines.

IN 184/2022 - Matters for the administrative protocol of requests for registration of synthetic and
semi-synthetic drugs classified as new and innovative, as provided for in §3 of article 4 of the
Collegiate Board Resolution - RDC No. 753, of September 28, 2022.

RDC 945/2024 - Guidelines and procedures for conducting clinical trials in the country with a view to
subsequently granting drug registration.

IN 338/2024 - Establishes, under the terms of ANVISA Collegiate Board Resolution No. 945, of November 29,
2024, the list of Equivalent Foreign Regulatory Authorities (AREE) and details the criteria for the adoption of the
optimized analysis procedure by reliance and by risk and complexity assessment of petitions for DDCM, DEEC,
substantial modifications to the product under investigation and substantial amendments to the clinical
protocol.
Changed by:
IN 345/2025

1.11. Assistance Programs for Experimental Drugs

Regulatory Theme 8.33 of the 2024/2025 Regulatory Agenda: Review of the regulation
for expanded access, compassionate use and post-study drug supply programs (Review
of RDC No. 38/2013).

RDC 38/2013 - Expanded access, compassionate use and post-study drug provision programs.
Changed by:
RDC 311/2019

1.12. Registration and post-registration of synthetic and semi-synthetic drugs

(generics, similar and new)

Regulatory Theme 8.6 of the 2024/2025 Regulatory Agenda: Consolidation of Post-Registration standards for
medicines (Revision of RDC 73/16, RDC 708/22 and RDC 413/20).

Regulatory Theme 8.11 of the 2024/2025 Regulatory Agenda: Express provision for the applicability of the post-
registration standard for synthetic products for the regularization of radiopharmaceuticals.

RDC 16/2007 - Technical regulation for generic drugs

Changed by:
RDC 51/2007
RDC 47/2009

RDC 17/2007- Technical regulation for registration of similar medicine

Changed by:
RDC 51/2007
RDC 53/2007
RDC 47/2009

Guide No. 13, version 1, dated 01/25/2018 - Guide for Submitting the Company's Technical Assessment Opinion (PATE).

RDC 73/2016 - Post-registration changes, cancellation of registration of drugs with synthetic and semi-synthetic
active ingredients
Changed by:
RDC 361/2020
RDC 406/2020
RDC 443/2020
RDC 731/2022
RDC 851/2024
RDC 882/2024

RDC 204/2017 - Classification in the priority category of registration, post-registration and prior approval
petitions in clinical research of medicines.
Changed by:
RDC 811/2023

RDC 290/2019 – Amends RDC 35/2012 which was revoked by RDC 957/2024.

Guide No. 20, version 2, dated 02/10/2021 - Guide to Quality Requirements for the Registration of Topical Products
and Transdermals.

Guide No. 49, version 1, dated 05/12/2021- Guide on requesting temporary emergency use authorization for
medications for COVID-19.

RDC 738/2022- Registration, notification, import and quality control of radiopharmaceuticals.

Changed by:
RDC 948/2024

IN 158/2022- Production of pilot batches of medicines.

RDC 753/2022 - Registration of medicines for human use with synthetic and semi-synthetic active ingredients,
classified as new, innovative, generic and similar.
Changed by:
RDC 948/2024
RDC 957/2024
Related acts:
IN 184/2022 - Matters for the administrative protocol of requests for registration of synthetic and
semi-synthetic drugs classified as new and innovative, as provided for in §3 of article 4 of the
Collegiate Board Resolution - RDC No. 753, of September 28, 2022.
Guide No. 1, version 2, dated 06/30/2017 - Preparation of the Summary Report on the validation of the
Medicine Manufacturing Process.
Guide No. 14, version 2, dated 10/29/2021 - Dissolution Guide Applicable to Generic, New and
Similar.
Guide No. 59, version 1, dated 03/20/2023 -Guide for submitting registration of new or innovative synthetic
and semi-synthetic medicines through the complete development route.
Guide No. 60, version 1, dated 03/20/2023 - Guide for submitting registration of new or innovative synthetic
and semi-synthetic drugs through the abbreviated development route.
Guide No. 61, version 1, dated 03/20/2023 - Guide for submitting registration of synthetic, semi-synthetic and
radiopharmaceutical drugs based on scientific literature.
Guide No. 64, version 1, dated 09/26/2023- Best practices guide for real-world data studies.
IN 184/2022 - Matters for the administrative protocol of requests for registration of synthetic and
semi-synthetic drugs classified as new and innovative, as provided for in §3 of article 4 of the
Collegiate Board Resolution - RDC No. 753, of September 28, 2022.

IN 258/2023- List of qualified impurities and their respective limits.

Changed by:
IN 337/2024

RDC 882/2024 - Criteria and procedures for classifying medicines as non-prescription and
reclassifying them as prescription medicines.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

RDC 957/2024 - Criteria for indicating a drug as a reference drug, procedures for including and
excluding drugs in the List of Reference Drugs.
Related act:
IN 353/2025 - Publishes the List of Reference Medicines.

RDC 821/2023- Amends RDC 53/2015 which was revoked by RDC 964/2025.

GUIDE 4_version 1_2015 - Guide for obtaining the degradation profile, and identification and qualification of
degradation products in medicines.

1.13. Use of analysis carried out by an Equivalent Foreign Regulatory Authority for
the purposes of regularizing products within the scope of GGMED

RDC 741/2022 - W general criteria for the admissibility of analysis carried out by a Regulatory Authority
Foreign Equivalent in the health surveillance process with Anvisa, through a procedure
optimized analysis. This standard belongs to the Cross-Cutting Themes library.

RDC 781/2023 - Amends Collegiate Board Resolution No. 750, of September 6, 2022. RDC 750/2022 has expired due to
loss of validity due to the expiration of the term.

IN 289/2024- Establishes, in accordance with the Resolution of the Collegiate Board - RDC No. 741, of August 10,
2022, the criteria applied for the optimized analysis procedure in which the assessments are used
conducted by the Equivalent Foreign Regulatory Authority (AREE) to analyze registration petitions and
post-registration of medicines, biological products, vaccines and letter of adequacy of input dossier
active pharmaceutical agent (CADIFA) in national territory.

IN 292/2024 - Specific criteria and procedures for defining the Equivalent Foreign Regulatory Authorities for the
sanitary inspection process of manufacturers of active pharmaceutical ingredients, Cannabis products for
medicinal purposes, medicines and biological products and establishes the optimized analysis procedure for
the purposes of Good Manufacturing Practices Certification.

RDC 875/2024 - Provides additional provisions on the registration of biosimilars through the
comparability development route.
RDC 945/2024 - Guidelines and procedures for conducting clinical trials in the country with a view to
subsequently granting drug registration.

1.14. Regulation of Cannabis products for medicinal purposes

Regulatory Theme 8.28 of the 2024/2025 Regulatory Agenda: Review of the regulation of Cannabis
products for medicinal purposes (Review of RDC No. 327/2019).

RDC 327/2019 - Procedures for granting Health Authorization for manufacturing and importing, as well
as establishing requirements for the marketing, prescription, dispensing, monitoring and inspection of
Cannabis products for medicinal purposes.

1.15.Registration and post-registration of biological products

Regulatory Theme 8.3 of the 2024/2025 Regulatory Agenda: Updating of technical and regulatory
requirements for the registration of Biological Products.

Regulatory Theme 8.6 of the 2024/2025 Regulatory Agenda: Consolidation of Post-Registration standards for
medicines (Revision of RDC 73/16, RDC 708/22 and RDC 413/20).

Regulatory Theme 8.20 of the 2024/2025 Regulatory Agenda: Review of the regulatory framework that deals with
post-registration changes to biological products and their cancellation.

RDC 55/2010 - Provides for the registration of new biological products and biological products.
Changed by:
RDC 406/2020
RDC 875/2024
RDC 948/2024

IN 65/2020 - Regulates the classification of post-registration changes and conditions and technical documents
necessary to support petitions for post-registration changes and cancellation of product registration
biological.

RDC 412/2020 - Establishes the requirements and conditions for carrying out stability studies for the purposes of
registration and post-registration changes of biological products.

GUIDE 02 version 2 of 2017 - Qualification in the transport of biological products

Guide No. 42, version 1, dated 12/02/2020 - Guide on the minimum requirements for submitting a request for
temporary authorization for emergency use, on an experimental basis, of Covid-19 vaccines.

RDC 616/2022- Composition of seasonal influenza vaccines to be used in Brazil.

Changed by:
RDC 933/2024

RDC 658/2022- General Guidelines for Good Manufacturing Practices for Medication.
Related act:
IN 137/2022- Good Manufacturing Practices complementary to Hemoderivative Medicines.

RDC 718/2022- Registration, changes and revalidations of registration of probiotic medicines.

Changed by:
RDC 912/2024
RDC 948/2024

RDC 801/2023- Permission for use, marketing and distribution of authorized vaccines and medicines
for emergency use under Resolution RDC No. 688/2022, which provides for procedures and
requirements for maintaining authorizations already granted and for new requests for temporary authorization
emergency use (EUA), on an experimental basis, of medicines and vaccines against Covid-19 for the
combating the SARS-COV-2 pandemic, which were manufactured up to May 21, 2023.

RDC 875/2024 - Provides additional provisions on the registration of biosimilars through the
comparability development route.

RDC 876/2024- Changed theRDC 413/2020, which provided for post-registration changes and cancellation of
registration of biological products and was revoked by RDC 913/2024.
Changed by:
RDC 913/2024

RDC 905/2024- Composition of Covid-19 vaccines to be used in Brazil.

IN 316/2024 - Update on the composition of Covid-19 vaccines to be used in Brazil.

RDC 912/2024 - Expiration dates and documentation required to maintain medication regularization.

RDC 913/2024 - Post-registration changes and cancellation of registration of biological products.

RDC 914/2024 - Registration of hyperimmune sera.

Changed by:
RDC 948/2024

IN 330/2024 - Composition of influenza vaccines to be used in Brazil.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.
1.16. Registration and post-registration of allergenic extracts and products for diagnostic
or therapeutic purposes

RDC 915/2024 - Registration and post-registration changes of industrialized allergenic products.

Changed by:
RDC 948/2024

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

1.17. Registration of radiopharmaceutical products

IN 81/2020-Regulates the list of radiopharmaceuticals that may present literature data for
proof of safety and efficacy.

RDC 567/2021 - Temporary and exceptional criteria and procedures for the import of industrialized
radiopharmaceuticals contained in IN 81/2020, from ANVISA and its updates, due to the risk of
shortages in national territory.This standard belongs to the Library of Ports, Airports and
Borders.
Changed by:
RDC 674/2022
RDC 737/2022
RDC 783/2023
RDC 853/2024
RDC 968/2025

RDC 738/2022- Registration, notification, import and quality control of radiopharmaceuticals.

Changed by:
RDC 948/2024

IN 319/2024 - Regulates the documentation required for the radiopharmaceutical registration protocol.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

1.18. Registration and post-registration of specific medicines

Regulatory Theme 8.14 of the 2024/2025 Regulatory Agenda: Registration and post-registration of specific
medicines (Revision of RDC 24/2011 and RDC 76/2016).

RDC 24/2011 – Registration of specific medicines

Changed by:
RDC 04/2015
RDC 97/2016
RDC 242/2018
RDC 406/2020
RDC 948/2024
Related act:
IN 09/2016 – Rules for package inserts and labeling of specific medicines

RDC 76/2016 - Carrying out post-registration changes, inclusions and cancellations of specific medicines.
Changed by:
RDC 113/2016
RDC 235/2018
RDC 882/2024

MS Ordinance 108/1991 – Regulates the composition of products for Oral Rehydration Therapy (ORT) and
determines the minimum content of information that must be provided to healthcare professionals and users.

RDC 29/2007 - Approve the rules regarding registration and marketing for the replacement of the open
infusion system with a closed one in large volume parenteral solutions.
Related acts:
SVS/MS Ordinance 272/1998 - Technical Regulation to establish the minimum requirements for
Parenteral Nutrition Therapy.

RDC 8/2001 - Technical Regulation that Establishes Good Manufacturing Practices for Polyelectrolytic
Concentrate for Hemodialysis - CPHD.
Changed by:
RDC 318/2019
RDC 768/2022

RDC 458/2020 - Classification for the purposes of health regulation of artificial tears and ocular lubricants and
amendments to the Collegiate Board Resolution - RDC No. 185, of October 22, 2001.This standard
belongs to the Health Products Library.

RDC 619/2022- Improvement of legislative technique and revocation of norms inferior to Decree issued by
National Health Surveillance Agency - ANVISA, components of the fifth consolidation stage,
Thematic relevance(s) MEDICINES in compliance with the provisions of Ordinance No. 488/GADIP-DP/ANVISA,
of September 23, 2021 and Decree No. 10,139 of November 28, 2019.
Changed by:
RDC 909/2024
RDC 910/2024

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

1.19. Registration, post-registration of dynamized drugs

Regulatory Theme 8.45 of the 2024/2025 Regulatory Agenda: Periodic updating of therapeutic
indications for registration and notification of dynamized drugs.

IN 25/2018 - Provides therapeutic indications for registration and notification of dynamized drugs.

IN 26/2018 - Provides for the power limits for the registration and notification of dynamized medicines.

IN 27/2018 - Publishes the List of references for assessing the safety and efficacy of dynamized
drugs.

PRT 17/1966 – Provides for the manipulation, prescription, industrialization and sale of products used in
homeopathy.

RDC 235/2018 - Provides for changes and inclusions of quality control in the registration and post-registration of dynamized
medicines, herbal medicines, specific medicines and biological products.

RDC 721/2022- Registration, renewal of registration, post-registration changes and notification of medicinal products
industrialized dynamized.
Changed by:
RDC 912/2024
RDC 948/2024

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

1.20. Notification, registration and post-registration changes of medicinal

gases classified as drugs.

RDC 870/2024 - Notification, registration and post-registration changes of medicinal gases classified as
medicines.

IN 301/2024 - List of medicinal gases classified as drugs subject to notification.

1.21. Registration, notification and post-registration of herbal medicines

Regulatory Theme 8.2 of the 2024/2025 Regulatory Agenda: Updating the requirements for quality
control of herbal medicines based on specific changes in RDC 26/2014.

Regulatory Theme 8.6 of the 2024/2025 Regulatory Agenda: Consolidation of Post-Registration standards for
medicines (Revision of RDC 73/16, RDC 708/22 and RDC 413/20).

RDC 26/2014 - Registration of herbal medicines and the registration and notification of traditional herbal
products.
Changed by:
RDC 66/2014
RDC 105/2016
RDC 106/2016
RDC 235/2018
RDC 768/2022
RDC 948/2024
Related acts:
IN 04/2014 - Guidance guide for the registration of Phytotherapeutic Medicine and registration and notification of
Traditional Phytotherapeutic Product
IN 02/2014 - List of simplified registration herbal medicines and List of simplified registration
traditional herbal products.Changed by:IN 10/2014

RDC 708/2022- Post-registration changes to herbal medicines and traditional products

phytotherapeutics.

Changed by:
RDC 882/2024

RDC 882/2024 - Criteria and procedures for classifying medicines as non-prescription and
reclassifying them as prescription medicines.

1.22. Quality control of herbal medicines

Regulatory Theme 8.2 of the 2024/2025 Regulatory Agenda: Updating the requirements for quality
control of herbal medicines based on specific changes in RDC 26/2014.

RDC 26/2014 - Registration of herbal medicines and the registration and notification of traditional herbal
products.
Changed by:
RDC 66/2014
RDC 105/2016
RDC 106/2016
RDC 235/2018
RDC 768/2022
RDC 948/2024
Related acts:
IN 04/2014 - Guidance guide for the registration of Phytotherapeutic Medicine and registration and notification of
Traditional Phytotherapeutic Product.
IN 02/2014 - List of simplified registration herbal medicines and List of simplified registration
traditional herbal products.Changed by:IN 10/2014

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

1.23. Low-risk medicinal products subject to simplified notification

Regulatory Theme 8.43 of the 2024/2025 Regulatory Agenda: Periodic update of the list of
Low-Risk Medicines subject to Simplified Notification (LMN).

RDC 576/2021 - N certification of low-risk drugs.

IN 106/2021- List of Low-Risk Medicines subject to notification.

Changed by:
IN 265/2023
1.24. Reference Drugs
Regulatory Theme 8.34 of the 2024/2025 Regulatory Agenda: Review of the criteria for indication,
inclusion and exclusion of drugs in the List of Reference Drugs.

Regulatory Theme 8.47 of the 2024/2025 Regulatory Agenda: Periodic update of the List of
Reference Drugs.

RDC 290/2019 – Amends RDC 35/2012 which was revoked by RDC 957/2024.

IN 353/2025 - Publishes the List of Reference Medicines.

Changed by:
IN 357/2025 – Updates the List of Reference Medicines (LMR).

1.25. Quality requirements for preparing registration and post-registration dossiers for
synthetic medicinal products.

Regulatory Theme 8.37 of the 2024/2025 Regulatory Agenda: Review of the quality requirements for
preparing registration and post-registration dossiers for synthetic medicines (Review of RDC No.
73/2016 and the quality part of RDC No. 753/2022).

RDC 690/2022 - Pilot Implementation of the Post-registration Change Management Protocol for
medicines with synthetic and semi-synthetic active ingredients.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

1.26. Rules for the approval of names for medicines, their supplements
and the formation of families of medicines.
Regulatory Theme 8.15 of the 2024/2025 Regulatory Agenda.

RDC 59/2014 – Names of medicines, their supplements and the formation of families of medicines for
simplified registration.

1.27. Requirements for demonstrating the safety and efficacy of new and
innovative drugs

1.28. International alignment of parameters for the validation of analytical

methods for medicinal products

Regulatory Theme 8.1 of the 2024/2025 Regulatory Agenda: International alignment of parameters for
the validation of analytical methods for medicines (Revision of RDC No. 166/2017).

RDC 166/2017 - V alidation of analytical methods.

Guide No. 10, version 1, dated 08/30/2017- Guide for statistical treatment of analytical validation.

1.29. Degradation products in drugs

Regulatory Theme 8.31 of the 2024/2025 Regulatory Agenda: Review of parameters for the verification
of degradation products in medicines (Revision of RDC 53/2015).

Regulatory Theme 8.41 of the 2024/2025 Regulatory Agenda: Periodic update of the list of qualified
impurities and their respective limits.

IN 258/2023- List of qualified impurities and their respective limits.

Changed by:
IN 337/2024

RDC 821/2023- Amends RDC 53/2015 which was revoked by RDC 964/2025.

GUIDE 4_version 1_2015 - Guide for obtaining the degradation profile, and identification and qualification of
degradation products in medicines.

1.30. Risk assessment and control of potentially carcinogenic nitrosamines in

medicinal products for human use.

RDC 677/2022- Risk assessment and control of potentially carcinogenic nitrosamines in inputs
Active Pharmaceutical Ingredients (API) and medicines for human use.

Guide No. 50, version 4, dated 07/31/2024 - Guide on Nitrosamine Control in Pharmaceutical Inputs
Assets and Medicines.

1.31. Conditional health regularization of medicines via commitment

term

RDC 55/2010 - Provides for the registration of new biological products and biological products.
Changed by:
RDC 406/2020
RDC 875/2024
RDC 948/2024

RDC 204/2017 - Classification in the priority category of registration, post-registration and prior approval
petitions in clinical research of medicines.
Changed by:
RDC 811/2023

RDC 753/2022 - Registration of medicines for human use with synthetic and semi-synthetic active ingredients,
classified as new, innovative, generic and similar.
Changed by:
RDC 948/2024
RDC 957/2024
Related acts:
IN 184/2022 - Matters for the administrative protocol of requests for registration of synthetic and
semi-synthetic drugs classified as new and innovative, as provided for in §3 of article 4 of the
Collegiate Board Resolution - RDC No. 753, of September 28, 2022.
Guide No. 1, version 2, dated 06/30/2017 - Preparation of the Summary Report on the validation of the
Medicine Manufacturing Process.
Guide No. 14, version 2, dated 10/29/2021 - Dissolution Guide Applicable to Generic, New and
Similar.
Guide No. 59, version 1, dated 03/20/2023 -Guide for submitting registration of new or innovative synthetic
and semi-synthetic medicines through the complete development route.
Guide No. 60, version 1, dated 03/20/2023 - Guide for submitting registration of new or innovative synthetic
and semi-synthetic drugs through the abbreviated development route.
Guide No. 61, version 1, dated 03/20/2023 - Guide for submitting registration of synthetic, semi-synthetic and
radiopharmaceutical drugs based on scientific literature.
Guide No. 64, version 1, dated 09/26/2023- Best practices guide for real-world data studies.
1.32. Health requirements for the regulation and monitoring of industrialized
medicines for human use throughout their life cycle

Regulatory Theme 8.24 of the 2024/2025 Regulatory Agenda.

RDC 55/2010 - Provides for the registration of new biological products and biological products.
Changed by:
RDC 406/2020
RDC 875/2024
RDC 948/2024

RDC 24/2011 – Registration of specific medicines

Changed by:
RDC 04/2015
RDC 97/2016
RDC 242/2018
RDC 406/2020
RDC 948/2024
Related act:
IN 09/2016 – Rules for package inserts and labeling of specific medicines

RDC 505/2021- Registration of advanced therapy product.

Changed by:
IN 270/2023
RDC 948/2024

RDC 718/2022- Registration, changes and revalidations of registration of probiotic medicines.

Changed by:
RDC 912/2024
RDC 948/2024

RDC 721/2022- Registration, renewal of registration, post-registration changes and notification of medicinal products
industrialized dynamized.
Changed by:
RDC 912/2024
RDC 948/2024

RDC 738/2022- Registration, notification, import and quality control of radiopharmaceuticals.

Changed by:
RDC 948/2024

IN 270/2023- Good Manufacturing Practices Complementary to Advanced Therapy Products.

RDC 875/2024 - Provides additional provisions on the registration of biosimilars through the
comparability development route.

RDC 912/2024 - Expiration dates and documentation required to maintain medication regularization.

RDC 914/2024 - Registration of hyperimmune sera.

Changed by:
RDC 948/2024

RDC 915/2024 - Registration and post-registration changes of industrialized allergenic products.

Changed by:
RDC 948/2024

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

1.33. General guidelines for the pilot implementation of the optimized assessment
procedure, based on health risk in applications for registration and post-
registration of medicines
RDC 823/2023 - Pilot project to implement the optimized evaluation procedure, based on risk criteria, to
confirm compliance with the health requirements of the documentation submitted to Anvisa in requests
for registration and post-registration changes of medicines.

1.34. Conditions and procedures for the registration of pre-pandemic

influenza vaccines, upgrade to a pandemic strain and authorization of
use, marketing and monitoring of pandemic influenza vaccines

RDC 846/2024 - Conditions and procedures for the registration of pre-pandemic influenza vaccines,
updating to a pandemic strain and authorization of use, marketing and monitoring of pandemic influenza
vaccines.

1.35. Regulation of Innovation in the areas of medicines and biological products.

Regulatory Theme 8.16 of the 2024/2025 Regulatory Agenda - To be regulated.

Complementary Law 182/2021 - Legal framework for startups and innovative entrepreneurship.

1.36. Commitment term for the purposes of registration, post-registration or temporary

authorization for emergency use of medicines

Regulatory Theme 8.38 of the 2024/2025 Regulatory Agenda.

1.37. Composition of seasonal influenza vaccine

Regulatory Theme 8.39 of the 2024/2025 Regulatory Agenda: Periodic update of the composition of the
seasonal Influenza vaccine.

RDC 616/2022- Composition of seasonal influenza vaccines to be used in Brazil.

Changed by:
RDC 933/2024

IN 330/2024 - Composition of influenza vaccines to be used in Brazil.

2. Consumer information

2.1. Drug Information Sheet and Labeling

Regulatory Theme 8.29 of the 2024/2025 Regulatory Agenda: Review of the rules for the
preparation, harmonization, updating, publication and provision of drug leaflets for patients and
healthcare professionals.

RDC 47/2009 – Rules for drug leaflets

Changed by:
RDC 58/2014
RDC 73/2016
RDC 406/2020
RDC 768/2022 Changed by:RDC 808/2023 reflected in RDC 47/2009.
RDC 769/2022
RDC 831/2023
Related acts:
RDC 60/2012 – Procedures within ANVISA for changes to drug package insert texts

IN 09/2016 – Rules for package inserts and labeling of specific medicines

Changed by:
RDC 619/2022 - Improvement of legislative technique and revocation of standards below the Decree
issued by the National Health Surveillance Agency - ANVISA, components of the fifth stage of
consolidation, Thematic relevance(s) MEDICINES in compliance with the provisions of Ordinance No. 488/
GADIP-DP/ANVISA, of September 23, 2021 and Decree No. 10,139, of November 28, 2019.
RDC 768/2022

IN 71/2020 - Inclusion of a statement about a new formula in the labeling of notified low-risk medicines,
traditional herbal products and cannabis products when their composition is changed.
Changed by:
RDC 619/2022 - Improvement of legislative technique and revocation of standards below the Decree
issued by the National Health Surveillance Agency - ANVISA, components of the fifth stage of
consolidation, Thematic relevance(s) MEDICINES in compliance with the provisions of Ordinance No. 488/
GADIP-DP/ANVISA, of September 23, 2021 and Decree No. 10,139, of November 28, 2019.
RDC 768/2022- Rules for the labeling of medicines.
Changed by:
RDC 808/2023

RDC 769/2022- Amends the Collegiate Board Resolution - RDC No. 47, of September 8, 2009, which
establishes rules for the preparation, harmonization, updating, publication and provision of package inserts
medicines for patients and healthcare professionals.

RDC 770/2022- Warning phrases for substances, therapeutic classes and control lists in package inserts and
medicine packaging.

IN 198/2022- Specific requirements for the labeling of large volume parenteral solutions,
solutions for irrigation, dialysis, plasma expanders and small volume parenteral solutions.

IN 199/2022- List of active pharmaceutical ingredients with phonetic or graphic similarity to others
inputs.

IN 200/2022- Substances, therapeutic classes and control lists that require warning phrases when
present in medicines, whether as an active ingredient or excipient, and their respective phrases.

RDC 882/2024 - Criteria and procedures for classifying medicines as non-prescription and
reclassifying them as prescription medicines.

RDC 885/2024 - Pilot project with transitional guidelines for implementing the digital package insert, allowing the
optional dispensing of the printed package insert on medication packaging, with a guarantee of its provision upon
request from the healthcare establishment, the prescribing professional or the patient.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

2.2. Commercial promotion and advertising of medicines

RDC 96/2008 - Provides for advertising, publicity, information and other practices whose objective is the
dissemination or commercial promotion of medicines.
Changed by:
RDC 23/2009
RDC 60/2009
RDC 576/2021
Related acts:
IN 05/2009

PRT SVS/MS 06/1999 (Chap. 11) - Application of PRT 344/1998 with regard to the distribution of free samples.

RDC 668/2022 - Prohibition of advertising, publicity and promotion, throughout the national territory, of
medicines that contain the active ingredient acetylsalicylic acid and use expressions that refer to the
symptoms of other pathologies that resemble the symptoms of dengue, as a measure of health interest
and in special circumstances of risk to health.
RDC 768/2022- Rules for the labeling of medicines.
Changed by:
RDC 808/2023

3. Regularization of services and establishments subject to health surveillance

and Good Practices

Decree No. 8,077/2013 - Regulates the conditions for the operation of companies subject to health licensing,
and the registration, control and monitoring, within the scope of health surveillance, of the products covered
by Law No.the6,360, of September 23, 1976, and provides other measures.

RDC 153/2017 – Classification of the Degree of Risk for economic activities subject to health surveillance, for
licensing purposes
Related act:
IN 66/2020 - List of National Classification of Economic Activities - CNAE of economic activities
subject to health surveillance by level of risk and dependent on information for health licensing
purposes.

RDC 275/2019 – Operating Authorization (AFE) and Special Authorization (AE) for Pharmacies and
Drugstores.
Changed by:
RDC 860/2024
Related acts:
PRT SVS/MS 344/1998 (Chapter 2) - Special Authorization.
PRT SVS/MS 06/1999 (Chapter 1, Chapter 8 and Chapter 10) - Application of PRT 344/1998 with regard to special
authorization (AE), technical responsibility and registration of establishments.

RDC 16/2014 – Criteria for petitioning for Operating Authorization (AFE) and Special Authorization (AE) for
Companies
Changed by:
RDC 40/2014
RDC 860/2024

RDC 887/2024 - Good practices for the distribution, storage, transportation and dispensing of medicinal gases. This
Resolution shall come into force 24 months after its publication. (Art. 87). When it shall come into force: Amends
RDC 16/2014; Amends RDC 275/2019.

3.1. Good Manufacturing Practices for Medication

Regulatory Theme 8.25 of the 2024/2025 Regulatory Agenda: Review of Good Manufacturing Practices
complementary to Sterile Medicines (Review of IN No. 35/2019).

RDC 658/2022- General Guidelines for Good Manufacturing Practices for Medication.
Related acts:
IN 35/2019 - Good Manufacturing Practices complementary to Sterile Medicines.Changed by:IN
109/2021
IN 127/2022 - Good Manufacturing Practices complementary to Biological Inputs and Medicines. IN
128/2022 - Good Manufacturing Practices complementary to Radiopharmaceuticals.
IN 129/2022- Good Manufacturing Practices complementary to Gases Active Substances and Gases
Medicinal.
IN 130/2022 - Good Manufacturing Practices complementary to Phytotherapeutics.
IN 131/2022 - Good Manufacturing Practices complementary to the sampling activities of raw
materials and packaging materials used in the manufacture of medicines.
IN 132/2022- Good Manufacturing Practices complementary to Liquid Medicines, Creams or
Ointments.
IN 133/2022- Good Manufacturing Practices for Pressurized Aerosol Medications
Metered Dosage for Inhalation.
IN 134/2022- Good Manufacturing Practices complementary to the computerized systems used in
manufacturing of medicines.
IN 135/2022- Good Manufacturing Practices complementary to Ionizing Radiation in the manufacture of
medicines.
IN 136/2022 - Good Manufacturing Practices complementary to Experimental Medicines. IN 137/2022 -
Good Manufacturing Practices complementary to Hemoderivative Medicines. IN 138/2022 - Good
Manufacturing Practices complementary to qualification and validation activities. IN 139/2022- Good
Manufacturing Practices complementary to reference and retention samples.

Guide No. 62, version 1, dated 07/19/2023- Quality Risk Management Guide.

Guide No. 8, version 3, dated 03/04/2022 - Guide for the Investigation of Out-of-Specification Results – FDE.

RDC 31/2013 - Technical regulations for common procedures for inspections of pharmaceutical
establishments in the States Parties and minimum content of inspection reports on pharmaceutical
establishments in the States Parties.

Guide No. 71, version 1, dated 01/05/2024 - Guide on Continuous Production of Active Pharmaceutical Ingredients
and Medicines.

3.2. Outsourcing of production stages, quality control analysis and

storage of medicines

RDC 234/2018 - Outsourcing of production stages, quality control analyses, transportation and
storage of medicines and biological products.
Changed by:
RDC 268/2019 – Amends RDC nº 234/2018.

3.3. Good Handling Practices in Pharmacies

Regulatory Theme 8.27 of the 2024/2025 Regulatory Agenda: Review of the Good Compounding Practices
standard in Pharmacies.

RDC 67/2007 - Good practices for handling magistral and officinal preparations for human use in
pharmacies.
Changed by:
RDC 87/2008
RDC 21/2009

RDC 18/2013 - Good practices for processing and storing medicinal plants, preparing and dispensing magistral
and officinal products of medicinal plants and phytotherapeutics in living pharmacies within the scope of the
Unified Health System (SUS).
RDC 610/2022-Revocation of rules below the Decree issued by the National Surveillance Agency
Sanitary - ANVISA, components of the fifth stage of consolidation, Thematic relevance(s) medicines,
food and transversal areas under the jurisdiction of the General Management of Monitoring of Products Subject to
Health Surveillance - GGMON in compliance with the provisions of Ordinance No. 488/GADIP-DP/ANVISA, of 23
September 2021 and Decree No. 10,139 of November 28, 2019.

3.4. Good Practices in Equivalence Centers

IN 123/2022- Inspection Guide for Drug Bioavailability/Bioequivalence Centers.

Changed by:
IN 358/2025

IN 298/2024- Inspection itinerary in pharmaceutical equivalence centers.

RDC 634/2022- Establishes the Information System for Pharmaceutical Equivalence and Bioequivalence Studies
(SINEB) and the National Registry of Volunteers in Bioequivalence Studies (CNVB).

RDC 926/2024 - Provides for the Certification of Good Practices for carrying out Bioavailability/
Bioequivalence studies of medicines and defines which Bioavailability/Bioequivalence studies of
medicines must be carried out in certified research centers.

RDC 927/2024 - Petitions for requests for qualification, renewal of qualification, post-qualification modifications,
outsourcing of testing, suspensions and cancellations of Pharmaceutical Equivalence Centers.
Related act:
IN 298/2024- Inspection itinerary in pharmaceutical equivalence centers.

IN 327/2024 - Pharmacodynamic study to prove the bioequivalence of topical dermatological

corticosteroids, in accordance with the Collegiate Board Resolution - RDC No. 742, of August 10, 2022.

IN 328/2024 - Bioequivalence studies for transdermal patches containing rivastigmine, under the terms of the
Collegiate Board Resolution - RDC No. 742, of August 10, 2022.

IN 329/2024 - List of administration forms and analytes to be quantified in relative bioavailability/

bioequivalence (BD/BE) studies and pharmacokinetic studies for immediate-release pharmaceutical
forms.

3.5. Good practices for storage, distribution and transportation of medical gases

RDC 430/2020 - Good Practices for Distribution, Storage and Transportation of Medicines.
Changed by:
RDC 653/2022
RDC 658/2022- General Guidelines for Good Manufacturing Practices for Medication.
Related act:
IN 129/2022- Good Manufacturing Practices complementary to Gases Active Substances and Gases
Medicinal.

RDC 671/2022- Technical criteria for granting Operating Authorization (AFE) to companies
manufacturers and bottlers of medical gases.

3.6. Good Practices for the Preparation of Radiopharmaceuticals in Healthcare Establishments

and Radiopharmacies

Regulatory Theme 8.7 of the 2024/2025 Regulatory Agenda General Guidelines for Good Practices for the Preparation
of Radiopharmaceuticals in Healthcare Establishments and Radiopharmacies - To be regulated.

RDC 38/2008 - Provides for the installation and operation of “in vivo” Nuclear Medicine Services.
Related act:
CNEN RES 159/2013 - Approves CNEN Standard No. 3.05 - “Safety and Radiological Protection Requirements
for Nuclear Medicine Services”.

IN 128/2022- Good Manufacturing Practices complementary to Radiopharmaceuticals.

IN 130/2022- Good Manufacturing Practices complementary to Phytotherapeutics.

3.7. Good Clinical Practices (GCP)

IN 122/2022- Inspection procedures in Good Clinical Practices for clinical trials with medicines.

RDC 945/2024 - Guidelines and procedures for conducting clinical trials in the country with a view to
subsequently granting drug registration.

3.8. Good Pharmacovigilance Practices

Regulatory Theme 8.26 of the 2024/2025 Regulatory Agenda: Review of the pharmacovigilance
good practice standard for drug registration holders.

RDC 36/2013 -Establishes actions for patient safety in health services.

RDC 406/2020 - Good Pharmacovigilance Practices for Holders of Registration of Medication for Human
Use.
Changed by:
RDC 718/2022

RDC 872/2024- Composition and operation of the Sentinel Network.

Related act:
IN 302/2024 - Accreditation and permanence in the Sentinel Network.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

RDC 967/2025 - Amends the Resolution of the Collegiate Board - RDC No. 406, of July 22, 2020, which provides for
Good Pharmacovigilance Practices for Holders of Registration of Medication for Human Use. This Resolution shall
come into force 365 (three hundred and sixty-five) days after the date of its publication. (Art. 2). When it comes
into force: Amends RDC 406/2020.

4. Control, inspection and monitoring of products subject to Health

Surveillance

PRT SVS/MS 344/1998 (Cap 3, Art.25 to Cap 8 and Cap 10) - Technical Regulation on substances and medicines
subject to special control.
Related act:
PRT SVS/MS 06/1999 (Chapter 2, Art.50 to Chapter 6 and Chapter 9)- Application of PRT 344/1998 with regard to
marketing, transportation, prescription, bookkeeping, balance sheet and emergency kit.

RDC 108/2016 - Provides the minimum requirements for inspection in establishments that work with
products subject to special control.

RDC 471/2021 - Criteria for prescribing, dispensing, controlling, packaging and labeling medicines
based on substances classified as antimicrobials for prescription use, alone or in combination,
listed in specific Normative Instruction.
Changed by:
RDC 768/2022
Related act:
IN 244/2023- Defines the list of substances classified as prescription antimicrobials,
isolated or in association, as referred to in the Collegiate Board Resolution - RDC No. 471, of 23
February 2021.

RDC 625/2022- Minimum requirements regarding the obligation, on the part of companies holding
drug records, communication of the implementation of the drug collection action to
competent health authorities and consumers, in the event of sufficient evidence or proof
of quality deviations that represent a risk, harm or consequence to health, as well as on the occasion of
cancellation of registration related to safety and efficacy.

4.1. Control and supervision of the drug distribution chain

RDC 305/2002 – Prohibition of entry and sale of raw materials and finished products obtained from
tissues/fluids of ruminant animals.
Related act:
RDC 68/2003 - Establishes conditions for the import, marketing and exposure to consumption of
products included in RDC 305/2002.

RE 552/2001 - P avoid the presence of boric acid and borax in the composition of topical antiseptic products,
in the form of ointments, talcum powders and creams, indicated for children, manufactured from this date.
RDC 52/2013 - Use of the Single Registration number, issued by the Ministry of Health, for the purpose of
complying with health regulations.

RDC 430/2020 - Good Practices for Distribution, Storage and Transportation of Medicines.
Changed by:
RDC 653/2022

RDC 782/2023- Revokes the Collegiate Board Resolution - RDC No. 624, of March 9, 2022.

RDC 802/2023 - Pharmaceutical inputs for restricted or prohibited use in medicines for human use.

4.2. Good practices for the distribution, storage and transportation of medicines

RDC 430/2020 - Good Practices for Distribution, Storage and Transportation of Medicines.
Changed by:
RDC 653/2022

4.3. National Medicines Control System (SNCM)

Regulatory Theme 8.17 of the 2024/2025 Regulatory Agenda: Regulation of procedures for
submitting the drug distribution map, in accordance with art. 3-A of Law No. 11,903, of January
14, 2019.

LAW 11.903/2009 - Tracking the production and consumption of medicines through electronic data
capture, storage and transmission technology.
Changed by:
Law 13.410/2016 – Amends Law 11,903/2009 to provide for the National Medication Control
System (SNCM).
Law 14.338/2022 - Amends Law 11,903/2009, to provide for digital drug leaflets.

4.4. Control of medicines and substances subject to special control

RDC 22/2014 – Provides for the National Controlled Products Management System (SNGPC)
Changed by:
RDC 586/2021- S temporary suspension, for an indefinite period, of the deadlines provided for in §3 and §4
of art. 10 of RDC nº 22/2014.

RDC 202/2002 - Prescription Notification “A” will not be required for the dispensing of medications based on the
substances morphine, medatone and codeine, or their salts, to patients undergoing outpatient treatment,
registered in the National Pain Assistance and Palliative Care Program, of the Unified Health System.

RDC 11/2011 – Provides for the control of the substance thalidomide and the medicine containing it
Changed by:
RDC 24/2012
RDC 50/2015
RDC 768/2022
RDC 873/2024
RDC 58/2007 -Improvement of the control and inspection of anorectic psychotropic substances
Changed by:
RDC 133/2016
RDC 689/2022
RDC 873/2024

RDC 50/2014 - Measures to control the marketing, prescription and dispensing of medicines containing
the substances anfepramone, femproporex, mazindol and sibutramine
Changed by:
RDC 133/2016
RDC 406/2020
Related act:
DCL 273/2014
Law 13454/2017 - Authorizes the production, marketing and consumption, under medical prescription, of the
anorectics sibutramine, anfepramone, femproporex and mazindol.

RDC 557/2021- Amends and revokes normative acts that are part of the fourth stage of the review process and
consolidation of normative acts within the scope of Anvisa, in compliance with Ordinance No. 201/GADIP-DP/ANVISA, of
February 20, 2020, and Decree No. 10,139, of November 28, 2019..
Changed by:
RDC 702/2022

RDC 565/2021- Repealed RDC 538/2021, before it came into force.

RDC 735/2022 - W control of the substance lenalidomide and medicinal products containing it.

IN 163/2022 - Defines, in a complementary manner to the Collegiate Board Resolution - RDC No. 735, of
July 13, 2022, the special control criteria for carrying out studies and research, including laboratory tests
and trials with lenalidomide and other substances included in list C3 of Annex I of SVS/MS Ordinance No.
344/1998, as well as medicines that contain them, except thalidomide.

RDC 873/2024 - Criteria and procedures for implementing computerized management of the distribution
of numbers for Prescription Notifications and Prescription Booklets in the national territory, through the
National Prescription Control System (SNCR).
Changed by:
RDC 956/2024

4.5. Control of medicines based on substances classified as antimicrobials,

for use under prescription, subject to specific control
Regulatory Theme 8.42 of the 2024/2025 Regulatory Agenda: Periodic updating of the list
of medicines based on substances classified as antimicrobials, for prescription use, subject
to specific control.

RDC 471/2021 - Criteria for prescribing, dispensing, controlling, packaging and labeling medicines
based on substances classified as antimicrobials for prescription use, isolated or in combination,
listed in a specific Normative Instruction.
Changed by:
RDC 768/2022
Related act:
IN 244/2023- Defines the list of substances classified as prescription antimicrobials,
isolated or in association, as referred to in the Collegiate Board Resolution - RDC No. 471, of 23
February 2021.
RDC 557/2021- Amends and revokes normative acts that are part of the fourth stage of the review process and
consolidation of normative acts within the scope of Anvisa, in compliance with Ordinance No. 201/GADIP-DP/ANVISA,
of February 20, 2020, and Decree No. 10,139, of November 28, 2019.
Changed by:
RDC 702/2022

4.6. Procedures for discontinuing the manufacture or import of

medicines, as well as for reactivation
Regulatory Theme 8.13 of the 2024/2025 Regulatory Agenda.

RDC 18/2014 – Mandatory communication to ANVISA of cases of temporary and permanent

discontinuation of the manufacture or import of medicines, as well as the reactivation of the manufacture
or import of medicines.
Related acts:
Manual dated 04/14/2016 - Standardization of information submission
Law No. 6,437/1977 (Art. 10, XL) Decree No. 8,077/2013 (Art. 23)

4.7. Products subject to health surveillance considered to be of traditional health

use

RDC 901/2024 - Manufacture and sale of Traditional Chinese Medicine products - TCM.

4.8. Pharmacovigilance

Regulatory Theme 8.8 of the 2024/2025 Regulatory Agenda: Formalization of the National
Pharmacovigilance System.

RDC 36/2013 -Establishes actions for patient safety in health services.

RDC 50/2014 -Measures to control the marketing, prescription and dispensing of medicines containing
the substances anfepramone, femproporex, mazindol and sibutramine
Changed by:
RDC 133/2016
RDC 406/2020
Related acts:
DCL 273/2014
Law 13454/2017 - Authorizes the production, marketing and consumption, under medical prescription, of the
anorectics sibutramine, anfepramone, femproporex and mazindol.

PRT SVS/MS 06/1999 (Chapter 4, Art. 89 and Art. 90)- Application of PRT 344/1998 with regard to
pharmacovigilance

RDC 406/2020 - Good Pharmacovigilance Practices for Holders of Registration of Medication for Human
Use.
Changed by:
RDC 718/2022

IN 63/2020 -Periodic Benefit-Risk Assessment Report (RPBR) to be submitted to Anvisa by Holders of

Registration of Medication for human use.

RDC 565/2021- Repealed RDC 538/2021, before it came into force.

RDC 718/2022- Registration, changes and revalidations of registration of probiotic medicines.

Changed by:
RDC 912/2024
RDC 948/2024

RDC 872/2024 - Composition and operation of the Sentinel Network.

Related act:
IN 302/2024 - Accreditation and permanence in the Sentinel Network.

RDC 948/2024 - Health requirements for the regulation of medicines for human use.

5. Health control in foreign trade and in ports, airports, borders and customs
areas

5.1. Procedures for importing/exporting medicines

RDC 305/2002 – Prohibition of entry and sale of raw materials and finished products obtained from
tissues/fluids of ruminant animals.
Related acts:
RDC 68/2003 - Establishes conditions for the import, marketing and exposure to consumption of
products included in RDC 305/2002.

RDC 939/2024 - Criteria for petitioning for Operating Authorization (AFE) and Special Authorization
(AE) for companies storing goods and products subject to sanitary control and inspection in Customs
Warehouses, Operating Authorization (AFE) for importers on behalf of and by order of third parties
or ordering goods and products subject to sanitary control and inspection, as well as exemption
from Operating Authorization (AFE) for other service providers in Ports, Airports and Borders.

RDC 234/2018 - Outsourcing of production stages, quality control analyses, transportation and
storage of medicines and biological products.
Changed by:
RDC 268/2019 – Amends RDC nº 234/2018.

RDC 2/2012 - Electronic protocol for issuing a registration certificate and a registration certificate for
exporting medicines.
Related topic:Registration, post-registration and notification of medicines

RDC 65/2014 -Prior notification of export of ephedrine, pseudoephedrine and pharmaceutical

specialties containing them.
RDC 81/2008 - Technical regulation of imported goods and products for health surveillance purposes.

RDC 208/2018 - Simplification of procedures for the import of goods and products subject to Health
Surveillance.

RDC 900/2024 - Procedure for releasing batches of blood products for consumption in Brazil and export.

RDC 96/2016 - Control of substances and medicines subject to special control in equivalence centers
and bioavailability/bioequivalence centers.

RDC 239/2002 - Establishments importing narcotic substances, listed in Lists “A1” and “A2” of ANNEX
I of Ordinance SVS/MS No. 344/98, as well as medicines containing them, must present to ANVISA, at
the time of requesting the Import Authorization, a document issued by the competent body of the
Exporting country, which must state that the imported object comes from lawful crops, authorized
by INCB.
Changed by:
RDC 12/2009

RDC 659/2022- Control of import and export of substances, plants and medicines subject to
special control.

RDC 669/2022- Minimum requirements to guarantee the quality of imported organic products.

RDC 670/2022- Minimum requirements to guarantee the quality of imported medicines.

RDC 944/2024- Procedure for releasing batches of heterologous hyperimmune vaccines and serums for
consumption in Brazil and for export.

5.2. Exceptional importation of medicines

RDC 8/2014 - Authorize the import of medicines included in the list of medicines released on an
exceptional basis and intended solely for hospital use or under medical prescription.
Changed by:
RDC 969/2025
Related act:
IN 1/2014 - List of medicines authorized for import on an exceptional basis.

IN 1/2014 - List of medicines authorized for import on an exceptional basis.

Changed by:
IN 352/2025

RDC 892/2024- Exemption, on an exceptional and temporary basis, from registration and on the requirements for
exceptional authorization for the import of medicines and vaccines acquired by the Ministry of Health for
prevention or treatment of Mpox, due to the public health emergency of international importance.
5.3. Procedures and format for generating the Drug Registration
Certificate, Drug Export Registration Certificate and Authorization for
Exclusive Export Purpose (AFEX).
Regulatory Theme 8.36 of the 2024/2025 Regulatory Agenda: Review of procedures and
format for generating the Drug Registration Certificate, Drug Export Registration
Certificate and Authorization for Exclusive Export Purpose (AFEX).

PRT 385/1997 - Approves manufacturing authorization model for exclusive export purposes.

PharmaRegAffairs Peru F
No ratings yet
PharmaRegAffairs Peru F
44 pages
Pharmaceutical Laws and Regulations
No ratings yet
Pharmaceutical Laws and Regulations
83 pages
09 Feb 2021 FDA Citizen - S Charter CDRR - CPR - 02 February 2020
No ratings yet
09 Feb 2021 FDA Citizen - S Charter CDRR - CPR - 02 February 2020
276 pages
Global Regulations of Medicinal, Pharmaceutical, and Food Products - 1st Edition Complete Book Download
100% (17)
Global Regulations of Medicinal, Pharmaceutical, and Food Products - 1st Edition Complete Book Download
17 pages
Guidance Document Formal Requirements: Identification Number: Valid From
No ratings yet
Guidance Document Formal Requirements: Identification Number: Valid From
44 pages
Forensic Pharmacy
No ratings yet
Forensic Pharmacy
83 pages
JPMA Regulations Engish
No ratings yet
JPMA Regulations Engish
120 pages
Drugregistrationgaidancefinal 160702121708
No ratings yet
Drugregistrationgaidancefinal 160702121708
182 pages
Regulatory Affairs
No ratings yet
Regulatory Affairs
33 pages
Key Points of The Medicine Registration Guidelines
No ratings yet
Key Points of The Medicine Registration Guidelines
5 pages
Global Regulations of Medicinal, Pharmaceutical, and Food Products 1st Edition ISBN 1032283629, 9781032283623 One-Click Download
No ratings yet
Global Regulations of Medicinal, Pharmaceutical, and Food Products 1st Edition ISBN 1032283629, 9781032283623 One-Click Download
17 pages
Regulatory Bodies Around The World
No ratings yet
Regulatory Bodies Around The World
28 pages
Juris PDF
No ratings yet
Juris PDF
4 pages
Bot 195236
No ratings yet
Bot 195236
23 pages
英文译稿《药品注册管理办法》
No ratings yet
英文译稿《药品注册管理办法》
33 pages
Drug Approval System
No ratings yet
Drug Approval System
60 pages
MLWH Japan
No ratings yet
MLWH Japan
190 pages
Medical Law & Ethics
No ratings yet
Medical Law & Ethics
124 pages
Drug Approval System of The Philippines PDF
No ratings yet
Drug Approval System of The Philippines PDF
56 pages
Control of Drugs and Cosmetics Regulations 1984 - Study Note
No ratings yet
Control of Drugs and Cosmetics Regulations 1984 - Study Note
7 pages
Import and Export Guidelines Final 2
No ratings yet
Import and Export Guidelines Final 2
32 pages
TGA1989
No ratings yet
TGA1989
394 pages
Unit 2 - Drug and Cosmetics Act 1940
No ratings yet
Unit 2 - Drug and Cosmetics Act 1940
24 pages
Who DMP RGS 98 5 R
No ratings yet
Who DMP RGS 98 5 R
208 pages
Insights of Regulatory Affairs in The Pharmaceutical Industry - A Review
No ratings yet
Insights of Regulatory Affairs in The Pharmaceutical Industry - A Review
23 pages
1.pharma Regulatory Affairs
100% (2)
1.pharma Regulatory Affairs
24 pages
GMP Compliance Guidelines 2021
No ratings yet
GMP Compliance Guidelines 2021
32 pages
Principal Documents Taken Account Preparation Procedures GCP Inspections Requested CHMP en
No ratings yet
Principal Documents Taken Account Preparation Procedures GCP Inspections Requested CHMP en
2 pages
Regulatory Aspects of Qum in India
83% (6)
Regulatory Aspects of Qum in India
40 pages
Introduction
No ratings yet
Introduction
111 pages
RA 9711 FDA Act
No ratings yet
RA 9711 FDA Act
19 pages
FDA
No ratings yet
FDA
15 pages
Modernizing The Food and Drugs Act To Accommodate A Product Lifecycle Approach
No ratings yet
Modernizing The Food and Drugs Act To Accommodate A Product Lifecycle Approach
31 pages
Introduction To CDSCO
No ratings yet
Introduction To CDSCO
11 pages
MRSA 2019 Regulations
0% (1)
MRSA 2019 Regulations
156 pages
WDU ch1&2
No ratings yet
WDU ch1&2
21 pages
Regulatory Agency
No ratings yet
Regulatory Agency
25 pages
2020 Pharmaceutical Administration and REgulation JApan
No ratings yet
2020 Pharmaceutical Administration and REgulation JApan
197 pages
ED401-9 Therapeutic Goods Act 1989. C2023C00240VOL01
No ratings yet
ED401-9 Therapeutic Goods Act 1989. C2023C00240VOL01
405 pages
Document From Rupsa
No ratings yet
Document From Rupsa
28 pages
FDA Citizen's Charter CDRR - CPR - 22 December 2020
100% (1)
FDA Citizen's Charter CDRR - CPR - 22 December 2020
274 pages
Drug Approval & CDSCO Guide
No ratings yet
Drug Approval & CDSCO Guide
12 pages
Drug Regulatory Guidelines
No ratings yet
Drug Regulatory Guidelines
17 pages
Regulatory Roundup Dashboard Flipbook 15. April 2024
No ratings yet
Regulatory Roundup Dashboard Flipbook 15. April 2024
34 pages
Regulatory Requirements of Tga and Row Countries
No ratings yet
Regulatory Requirements of Tga and Row Countries
18 pages
Law Topic Questions
No ratings yet
Law Topic Questions
42 pages
Pqaqc ch1&2 (Autosaved)
No ratings yet
Pqaqc ch1&2 (Autosaved)
21 pages
2022 - PH MGT 1 - WEEK 7 - Regulatory Aspect
No ratings yet
2022 - PH MGT 1 - WEEK 7 - Regulatory Aspect
16 pages
Ans The Following 6 Marks
No ratings yet
Ans The Following 6 Marks
8 pages
Drugs & Cosmetics Regulation Act
No ratings yet
Drugs & Cosmetics Regulation Act
31 pages
Therapeutic Goods Act 1989
No ratings yet
Therapeutic Goods Act 1989
613 pages
Regulatory Requirements of Eu and India
No ratings yet
Regulatory Requirements of Eu and India
30 pages
Medicines Act 1981: As at 5 April 2023
No ratings yet
Medicines Act 1981: As at 5 April 2023
752 pages
4.OHS and Legislation in The Industry
No ratings yet
4.OHS and Legislation in The Industry
4 pages
D&C Act 1940 and Rules 1945
No ratings yet
D&C Act 1940 and Rules 1945
62 pages
MDS 2009 Medicines Regulation and Governance PDF
No ratings yet
MDS 2009 Medicines Regulation and Governance PDF
67 pages
Intern Report in CLZ
No ratings yet
Intern Report in CLZ
33 pages
The Formulation and Evaluation of Customized Prednisolone Gel Tablets Prepared by An Automated Extrusion-Based Material Deposition Method
No ratings yet
The Formulation and Evaluation of Customized Prednisolone Gel Tablets Prepared by An Automated Extrusion-Based Material Deposition Method
15 pages
(De Gruyter Textbook) - Pharmaceutical Chemistry. Volume 1 - Drug Design and Action. 1-Walter de Gruyter (2024)
No ratings yet
(De Gruyter Textbook) - Pharmaceutical Chemistry. Volume 1 - Drug Design and Action. 1-Walter de Gruyter (2024)
234 pages
Regulatory Affairs Specialist Resume
No ratings yet
Regulatory Affairs Specialist Resume
5 pages
ASME BPE-2019 Bioprocessing Standard
No ratings yet
ASME BPE-2019 Bioprocessing Standard
2 pages
Puretol Data Sheet
No ratings yet
Puretol Data Sheet
2 pages
Clinical Pharmacy Specialist
No ratings yet
Clinical Pharmacy Specialist
2 pages
PICU Inotrope Administration Guide
100% (1)
PICU Inotrope Administration Guide
8 pages
Mangrove Bioprospecting Potential
No ratings yet
Mangrove Bioprospecting Potential
0 pages
Validation Master Plan Example - Long
No ratings yet
Validation Master Plan Example - Long
31 pages
Kajian Pustaka: Uji Kepekaan Antibiotik Pada Corynebacterium
No ratings yet
Kajian Pustaka: Uji Kepekaan Antibiotik Pada Corynebacterium
13 pages
Itraconazole
No ratings yet
Itraconazole
17 pages
Excipients Used in NDDS
No ratings yet
Excipients Used in NDDS
4 pages
1 Mba Project 2023
No ratings yet
1 Mba Project 2023
81 pages
Migration North of The Border Is N. Irish Pharmacies Gain: Special Report
No ratings yet
Migration North of The Border Is N. Irish Pharmacies Gain: Special Report
2 pages
Examples of Groupings
No ratings yet
Examples of Groupings
12 pages
Lecture 4: Drug Discovery and Development: THER 201
No ratings yet
Lecture 4: Drug Discovery and Development: THER 201
8 pages
Nutraceutical PDF
No ratings yet
Nutraceutical PDF
77 pages
Classes of Topical Corticosteroids
No ratings yet
Classes of Topical Corticosteroids
3 pages
Pilot Plant Scale Up Technique
100% (10)
Pilot Plant Scale Up Technique
84 pages
Cold Chain - 16th To 21 March 2015 - Mumbai
100% (1)
Cold Chain - 16th To 21 March 2015 - Mumbai
35 pages
Quetiapine
No ratings yet
Quetiapine
2 pages
Amoxicillin Uses, Dosage, Side Effects, Warnings
No ratings yet
Amoxicillin Uses, Dosage, Side Effects, Warnings
5 pages
Indian Pharmacopoeia Vol 1 6th Edition Ipc 2025 Easy Download
No ratings yet
Indian Pharmacopoeia Vol 1 6th Edition Ipc 2025 Easy Download
84 pages
Pharmaceutical NDA Sponsors
No ratings yet
Pharmaceutical NDA Sponsors
415 pages
DAFTAR OBAT Apotek
No ratings yet
DAFTAR OBAT Apotek
3 pages
Clopidogrel Analysis for Pharmacists
No ratings yet
Clopidogrel Analysis for Pharmacists
3 pages
2.10 Risk-Based Qualification For The 21st Century
No ratings yet
2.10 Risk-Based Qualification For The 21st Century
7 pages
Ebook How The FDA Trains and Prepares Investigators
No ratings yet
Ebook How The FDA Trains and Prepares Investigators
46 pages
Elsevier's Integrated Review Pharmacology 2nd Edition Updated Edition Download
89% (9)
Elsevier's Integrated Review Pharmacology 2nd Edition Updated Edition Download
15 pages