ICH Guidelines: An Overview

Dr. Renuka J. Das

NEED TO HARMONIZE
• Realization was driven by tragedies, such as that with thalidomide in Europe in the 1960s.

• The 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting
and evaluating the data on safety, quality and efficacy of new medicinal products.

 Many time-consuming and expensive test procedures required in order to market new
products internationally.
 Ever rising costs of health care making safe and efficacious new treatments
available to patients in need.

 Divergence in technical requirements from country to country.

 INTERNATIONAL CONFERENCE ON
HARMONIZATION (APRIL1990)

 ICH stands for “International Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals for Human Use”.

MISSION
 To make recommendations towards achieving greater harmonization in the
application of technical guidelines and requirements for pharmaceutical product
registration, there by reducing duplicating of testing carried out during the research
and development of new medicines for human use.
INITIATION OF ICH
▪ Harmonization of regulatory requirements was pioneered by
European Community (Now EU)
▪ Success achieved by Europe demonstrated that harmonization was possible
▪ At same time there were bilateral discussions between Europe,
Japan & US, on possibilities for harmonization.
▪ The birth of ICH took place at meeting in April 1990 in Brussels
▪ Topics selected for harmonization –
- SAFETY
- QUALITY &
- EFFICACY
STRUCTURE
Regulatory Body Industry

Ministry of European
US Food & Pharmaceutical
Health, Labor Federation of Japan
Research &
European Drug Pharmaceutical Pharmaceutical
and Welfare, Industries Association Manufactures
Union (EU) Administrati of America
Japan Associations (JPMA)
on (US-FDA) (PhRMA)
(MHLW) (EFPIA)
MEMBERS AND OBSERVERS
 EU
 EFPIA (European federation of pharmaceutical industries’ associations).
 MHLW (Ministry of health, Labor and welfare,Japan).
 JPMA (Japan Pharmaceuticals manufacturersAssociation).
 US FDA.
 PhRMA(pharmaceutical research and manufacturers association).

▪ WHO, EFTA (European Free Trade Association), Canada, Austrila –

Non voting members
▪ IFPMA (International federations of Pharmaceutical Manufactures Association)
representative
ORGANIZATION
EVOLUTION OF ICH
 First decade :
significant progress in the development of ICH Guidelines on Safety ,Quality and
Efficacy topics and also work on a number of important
multidisciplinary topics.
 Second decade:
implementation of ICH Guidelines in the ICH regions.
Expand communication and information on ICH with other regions
 Third decade :
extending the benefits of harmonization beyond the ICH regions. Training ,as well
as active participation of other regions in Guideline development is seen as key in
this effort.
OBJECTIVES OF ICH
▪ Promote public health by early availability of drug in the market.
▪ Maintaining safeguards on quality, safety and efficacy.
▪ Improve efficiency of new drug development ,Reduce registration cost.
▪ Less expensive drugs for patients.
▪ Prevent the duplication of clinical trails in humans.
▪ Minimize the animal use with out compromising in safety ,efficacy of the
product.
▪ Mutual acceptance of clinical data by regulatory authority.
▪ Reducing testing duplication.
THE GUIDELINES – Q S E M
▪ Quality (Q1-Q11)
chemical & Pharmaceutical QA

▪ Safety (S1-S10,M3)
dealing with invitro & in vivo preclinical testing

▪ Efficacy (E1-E16, Except E13)

clinical studies in human beings

▪ Multidisciplinary (M1-M8)
terminology, electronic standards, common documents
QSEM
QUALITY :
Harmonization achievements in the Quality area include such as the conduct of
stability studies, defining relevant thresholds for impurities testing and a more
flexible approach to pharmaceutical quality based on Good Manufacturing Practice
(GMP) risk management.

SAFETY :
ICH has produced a comprehensive set of safety Guidelines to potential risks like
carcinogenicity, genotoxicity and reprotoxicity etc
EFFICACY
The work carried out by ICH under the Efficacy heading is concerned with the design,
conduct, safety and reporting of clinical trials. It also covers novel types of medicines
derived from biotechnological processes and the use of pharmacogenetics / genomics
techniques to produce better targeted medicines.
MULTIDISCPLINARY :
These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety
and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common
Technical Document (CTD) and the development of Electronic Standards for the Transfer of
Regulatory Information (ESTRI).
 QUALITY GUIDELINES
 Q1A - Q1F :Stability
 Q2 : Analytical Validation
 Q3A - Q3D : Impurities
 Q4 - Q4B : Pharmacopoeias
 Q5A - Q5E : Quality of Biotechnological Products
 Q6A- Q6B : Specifications
 Q7 : Good Manufacturing Practice
 Q8 : Pharmaceutical Development
 Q9 : Quality Risk Management
 Q10 : Pharmaceutical Quality System
 Q11 : Development and Manufacture of Drug Substances
 Q12 : Lifecycle Management
 Q13 : Continuous Manufacturing of Drug Substances and Drug Products
 Q14 : Analytical Procedure Development
SAFETY GUIDELINES
 S1A - S1C : Carcinogenicity Studies
 S2 : Genotoxicity Studies
 S3A - S3B : Toxicokinetics and Pharmacokinetics
 S4 : Toxicity Testing
 S5 : Reproductive Toxicology
 S6 : Biotechnological Products
 S7A - S7B : Pharmacology Studies
 S8 : Immunotoxicology Studies
 S9 : Nonclinical Evaluation for Anticancer Pharmaceuticals
 S10 : Photosafety Evaluation
 S11 : Nonclinical Pediatric Safety
EFFICACY GUIDELINES
 E1 : Clinical Safety for Drugs used in Long-  E10 : Choice of Control Group in Clinical
TermTreatment Trials
 E2A - E2F : Pharmacovigilance  E11 - E11A : Clinical Trials in Pediatric
Population
 E3 : Clinical Study Reports
 E12 :Clinical Evaluation by Therapeutic
 E4 : Dose-Response Studies Category
 E5 : Ethnic Factors  E14 :Clinical Evaluation of QT
 E6 : Good Clinical Practice  E15 :Definitions in Pharmacogenetics /
 E7 :Clinical Trials in Geriatric Population Pharmacogenomics

 E8 : General Considerations for Clinical  E17 : Multi-Regional Clinical Trials

Trials  E18 : Genomic Sampling
 E9 :Statistical Principles for Clinical Trials
MULTIDISCIPLINARY GUIDELINES
 M1 : MedDRATerminology
 M2 : Electronic Standards
 M3 : Nonclinical Safety Studies
 M4 : Common Technical Document .
 M5 : Data Elements and Standards for Drug Dictionaries
 M6 : Gene Therapy
 M7 : Mutagenic impurities
 M8 : Electronic Common Technical Document (eCTD)
 M9 : Biopharmaceutics Classification System-based Biowaivers
 M10 : Bioanalytical Method Validation
THANK YOU