WHO certification scheme on the

quality of pharmaceutical products

WHO certification scheme on the
quality of pharmaceutical products
 © World Health Organization 2025
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Contents
Acknowledgements iv

1. Introduction  1

2. Background 2

3. Purpose and evolution of the WHO Certification Scheme 3

Evolution of the Scheme 3

Key changes to the Scheme 4

4. Regulatory ecosystem and other tools  5

5. Experiences from regulatory authorities and industry perspectives 6

5.1 Reflections from National Regulatory Authority of Cuba, Center for State Control of Medicines,
Medical Equipment and Devices (CECMED)  6
5.2 European Medicines Agency (EMA) 9
5.3 Singapore Health Sciences Authority (HSA) 10
5.4 Reflections from Industry – International Federation of Pharmaceutical Manufacturers
and Associations (IFPMA) 11

6. Strengths and limitations of the Certification Scheme 14

7. The way forward  15

References 16

iii
Acknowledgements
This publication was a true collaborative effort, Medical Equipment and Devices (CECMED),
and we would like to express our sincere gratitude La Habana, Cuba.
to the collaborators for their technical expertise
and dedication developing, writing and revising Ms Virginia Rojo Guerra, Head of the Procedures
this publication: Office, European Medicines Agency (EMA),
Amsterdam, The Netherlands.
Dr Samvel Azatyan, Team Lead of Regulatory
Convergence and Networks, WHO headquarters, Ms Alice Lim, Senior Regulatory Specialist,
Geneva, Switzerland. Licensing and Certification Branch, Audit and
Licensing Division, Health Products Regulation
Dr Luther Gwaza, Team Lead of Norms Group, Singapore Health Sciences Authority (HSA),
and Standards for Pharmaceuticals, WHO Singapore, Singapore.
headquarters, Geneva, Switzerland.
Ms Nevena Miletic, co-Chair of the International
Dr Djamila Reis, Technical Officer at Regulatory Federation of Pharmaceutical Manufacturers
Convergence and Networks, WHO headquarters, and Associations (IFPMA) Certification of
Geneva, Switzerland. Pharmaceutical Products (CPP) Network and Ms
Mandy Zeigler, co-Chair of the IFPMA CPP Network
Dr Celeste Sánchez, Head of Policy and Regulatory (at the time of discussing the content), Geneva,
Affairs, Center for State Control of Medicines, Switzerland.

iv
1. Introduction
Medical products play a significant role in global of cooperation to control the quality of medicines
public health, and ensuring their quality is vital circulating in the global market (1).
for protecting human health and the well-being
of communities across the globe. Without the The World Health Organization (WHO) developed
assurance of quality, the public is exposed to the the Certification Scheme on the quality of
dangers of medicines that may not be effective, pharmaceutical products moving in international
or worse may be harmful. The recent cases of commerce (hereinafter referred to as “the
contamination of cough syrup causing preventable Scheme”) to help Member States ensure the
deaths of young children emphasize the urgency of quality of medicines circulating in the global
the collective use of available tools and resources market.
to prevent such events. These cases in which well-
This document provides an overview of the
known toxic substances, such as diethylene and
Scheme, its purpose, evolution and regulatory
ethylene glycol were present in locally produced
ecosystem, as well as its strengths, weaknesses
and exported products, highlight the importance
and recommendations for its use in the context of
other available regulatory tools.

1
2. Background
The WHO Certification Scheme on the quality still a serious global challenge. Access to and use of
of pharmaceutical products circulating in all medical products at country and regional level
international commerce was established in 1969 depends on regulatory approval and this requires
to help Member States ensure the quality of regulatory authorities to have at least a minimum
medicines circulating in the global market. At that capacity for regulation of medical products.
time, the Scheme was focused on the certification
of finished pharmaceutical products only. Over the Unfortunately, less than one third of the national
years the Scheme has evolved, and several other regulatory authorities (NRAs) of WHO Member
tools have been introduced to complement the States have the capacity to perform the key
certification process. The Scheme was initiated regulatory functions (2) and the remaining
in response to the increasing circulation of countries are struggling to improve their regulatory
substandard and falsified medicines in the global capacity and ability to perform. Moreover, the
market. It was designed to establish a common gap between regulatory authorities in low and
standard for the evaluation of pharmaceutical middle-income countries and those in high-income
products, particularly those that were to be countries persists. Given the globalization of the
exported from one country to another. The Scheme markets, the complexity of health technologies,
was established as a voluntary programme, the sophistication of information technologies,
which means that countries and pharmaceutical the increasing difficulties faced by the supply
manufacturers could choose whether or not chains and the revolutionary change in regulatory
to participate. science, combined with much higher public
expectations, the framework for NRAs’ activities is
The importance of the Scheme lies in its role in increasingly challenging.
promoting access to medical products, which is

2 WHO certification scheme on the quality of pharmaceutical products

3. Purpose and evolution of the WHO
Certification Scheme
The Scheme was proposed with the objective in the Scheme notifies the WHO Director-General.
of ensuring the safety, quality and efficacy of In the context of the Scheme, there is no provision
the medical products that are in circulation in for external inspection or assessment of Member
Member States. The Scheme is the oldest example States National Regulatory Authorities before they
of regulatory reliance and has been implemented join the Scheme. Therefore, each Member State
since 1969. However, the world has changed joining the Scheme assumes the responsibility for
since that time and WHO has introduced many determining, through a process of self-assessment,
tools and programmes to strengthen regulatory whether they fulfil the conditions described in
systems globally, especially for vulnerable the guidance. After receipt of the notification, a
populations in low-income countries. Among the formal response is sent to the Member State and
many developments is the guidance document the information on the WHO website is updated.
on good reliance practices (3). Despite all these Most of the WHO Member States are already
changes, the Scheme remains an established tool, participating in the Scheme, with participation
still considered relevant by Member States and reaching more than 90% in some WHO regions.
effective in protecting public health. However, it
requires collective input from many stakeholders
and regular revisions to ensure it remains fit
Evolution of the Scheme
for purpose.
In 1963 a World Health Assembly resolution
The Scheme is an international voluntary
called for an examination of the ways and
agreement, created to provide assurance to
means of ensuring that medicines exported
participating countries regarding the quality of
from a producing country comply with control
medical products in the international market and
requirements applied in that country for domestic
circulating in their domestic markets. Several
use. This was the beginning of the discussions
different documents are issued under the Scheme,
on the development of the WHO Certification
but the primary document is the Certificate of
Scheme, established in 1969 with the World Health
Pharmaceutical Product (CPP).
Assembly resolution WHA 22.50 (4).
The overarching key principles of the Scheme are
The Scheme is designed to be flexible, so that it
to foster international cooperation, to make best
can be continuously improved ensuring that it
use of available resources and expertise, and avoid
remains fit for purpose. Over the decades during
duplication while preparing for national regulatory
which the Scheme has been implemented, many
decisions. It is therefore considered as an
challenges have been identified by Member
administrative tool for use by Member States’ NRAs
States and other stakeholders, specifically the
to support the exchange of regulatory information
pharmaceutical industry. Those challenges and
based on a voluntary non-binding agreement. The
lessons learned triggered the periodic revisions.
procedure for joining the Scheme is based on self-
In 1975, resolution WHA 28.65 expanded the
assessment and there are no other assessment
scope of the Scheme to include the regulatory
mechanisms. A Member State willing to participate

3
status of the product in the exporting country countries. Focusing on improving efficacy and
as well as compliance with good manufacturing communication, the mains changes are as follows:
practices (GMP) (5). Later, in 1988, in accordance
with resolution WHA 41.18, there were revisions • A framework was established to enable regional
concerning active ingredients, veterinary products, organizations, such as the European Medicines
and product information and labelling (6). Agency, to join the Scheme and allow others to
Further revisions were made in 1992 and 1997 in do so in the future.
line with resolutions WHA 45.29 and WHA 50.3, • The mandatory requirement for a CPP is to be
respectively (7,8). In 2007, the forty-second Expert discouraged if the receiving authority has the
Committee on Specifications for Pharmaceutical capability to conduct a full review of quality,
Preparations (ECSPP) discussed and identified safety and efficacy. For example, if regulators
several problems with the operation of the can perform GMP inspections themselves, no
Scheme (9). In 2008, after considering the WHO CPP should be required, ensuring that it is not
consultation and working documents and in light redundant and does not impose an unnecessary
of the changing environment, including the rapid administrative burden.
globalization of the pharmaceutical manufacturing • Inclusion of contact details using updated tools
sector, coupled with regulatory and procurement such as websites and e-mails to enable the
changes, the forty-third ECSPP recommended that receiving authorities to verify the authenticity
the WHO Certification Scheme on the quality of of the certificates with the exporting country
pharmaceutical products moving in international through direct communication between
commerce should be revised (10). Following the the regulators.
recommendations of the fifty-second ECSPP in • A standard time frame was included to
2017 (11), the WHO Secretariat prepared a proposal stimulate efficiency and ensure predictability
for revision of the Scheme and submitted it for of the processes and thus allow industry to
public consultation. plan accordingly.
The revised Scheme followed the WHO process • Legalization processes should be discouraged.
of consultations, discussions with stakeholders To ensure authenticity, many countries
and inclusion of their feedback. Additionally, after require legalization by the embassies, which
the comments were received, several external is a cumbersome process. It is important to
meetings were held to promote consensus. highlight that there are or could be other ways
available to verify the authenticity of the CPP.
• Inclusion of different trade names to reflect
current procurement practices and facilitate
Key changes to the Scheme more extensive information exchange
To the extent possible, the revised Scheme aligns between regulators.
with the available tools introduced by WHO as • As the use of the electronic CPP (eCPP) has
well as with current regulatory and scientific become more common, this option was
thinking. At the same time, it maintains the included as a key change for facilitating the
original core principles as a voluntary non-binding Scheme, although revision of the legislation is
system based on self-assessment and open to necessary for some NRAs.
all WHO Member States, currently more than 140

4 WHO certification scheme on the quality of pharmaceutical products

4. Regulatory ecosystem and other
tools
The challenges of assuring the quality of medicines participating in this scheme rely on each other
circulating in international commerce persist, when it comes to GMP inspections. Other
whether the products are imported or produced mechanisms include the WHO prequalification
locally, and need to be addressed. It is important programme (13) and the Collaborative Registration
to underline that the Scheme is one of many tools Procedure (CRP) (14). The bilateral agreements
available to regulators in terms of reliance, which between countries also are part of this new
also include information sharing, collaborative regulatory context.
procedures and mutual recognition. It noteworthy
that in the 1960s, when the Scheme was first Being one of the first reliance mechanisms
implemented, few countries were producing and introduced in regulatory practice, it is important
exporting pharmaceutical products. Furthermore, to ensure that the CPP Scheme is not leading to
few of these countries had a regulatory system duplication of efforts or imposing an unnecessary
in place to control pharmaceuticals and even administrative burden when requested in
fewer had a strong regulatory system. Since a regulatory context that may make its use
then, the number of exporting countries has redundant. It is therefore important to situate the
multiplied and there are very complex supply Scheme within this broader context of available
chains for pharmaceuticals, but there is also regulatory tools to better understand the revision
improved regulatory oversight in many countries. process, based on feedback and various requests
As an example of regulatory improvement, more from stakeholders. The update process must
countries now require a dossier for marketing ensure that the Scheme evolves over time to
authorization than in the 1960s. Moreover, other reflect best practices, bridging the gaps and using
reliance mechanisms are now available, such all reliance tools in a complementary way that is
as the Pharmaceutical Inspection Co-operation tailored to the national regulatory framework.
Scheme (PIC/S Scheme (12)): the regulators

5
5. Experiences from regulatory
authorities and industry perspectives
Regulatory authorities from different WHO regions requirements for drug registration processes
have varying experiences with the Scheme. This in the Region of the Americas. Towards more
section presents some examples. timely access to medicines and more convergent
regulatory approaches”, which was undertaken
jointly with the regional pharmaceutical
industry association (Latin American Federation
5.1 Reflections from National
of the Pharmaceutical Industry, FIFARMA).
Regulatory Authority of Cuba, Center
• CECMED participated in the eighteenth
for State Control of Medicines, International Conference of Drug Regulatory
Medical Equipment and Devices Authorities (ICDRA) Workshop 2: “Certification
(CECMED) of Pharmaceutical Products: Is it still ‘fit for
purpose’ in a modern environment?”
• CECMED participated in public consultations
Background
and meetings of the NRA on updating the
Scheme and collaborated with WHO in assessing
The former Center for State Control of Drug
comments and proposing texts for the updated
Quality (currently CECMED), joined the WHO
guidelines approved during the fifty-fifth
Certification Scheme on 18 June 1997, without
meeting of the ECSPP.
reservations for both imported and exported
pharmaceutical products. CECMED issues CPP • In 2021 CECMED worked on preparing an
certificates for medicines to be exported (as the article with officers of WHO on updating the
certifying NRA) and also requests CPP certificates Certification Scheme, which was published in
(from the exporting country) when importing the section on regulatory news in WHO Drug
medicines. In November 1997, the Ministry of Information (17).
Public Health issued an Instruction stipulating
the issuance characteristics of the CPPs and, Results and challenges for the Region of the
starting in 2000, expanded the Sanitary License Americas
System to all pharmaceutical operations. The
CPP is a requirement for marketing authorization, The study by CECMED-FIFARMA with the
established in Cuban regulations. participation of the NRAs of the Region of the
Americas identified strengths and weaknesses
The current CECMED has been involved in several
in the implementation of the WHO Scheme.
global activities related to the Scheme and the
Challenges were associated with:
CPP, which are outlined below:
• varying practices and guidelines on the
• From 2018 to 2021, CECMED coordinated the
use of the CPP and lack of uniformity in the
Project of the Pan American Network for Drug
methodology for requesting CPPs;
Regulatory Harmonization (PANDRH), “Assessing
the Certificate of Pharmaceutical Product (CPP)

6 WHO certification scheme on the quality of pharmaceutical products

• CPP as a requirement for starting the process • limited number of issuing/applicant-certifying
of assessment for marketing authorization, authorities accepting eCPP, indicating
associated with extended delay; that the region is not yet prepared to work
• no reduction of the time or extent of the with electronic documentation, despite its
assessment of the dossier when a CPP is numerous advantages.
available; it does not imply fast tracking,
The final recommendations of the project were
nor simplified procedures for marketing
addressed to PANDRH, and most of them were
authorization;
included in the updated WHO Scheme guidelines.
• lack of accurate information on alignment with
WHO GMP between participating countries; Situation in Cuba regarding the Guidelines on the
• lack of support from the CPP for trade names of implementation of the WHO certification scheme on
a product that differ between the CPP-issuing the quality of pharmaceutical products moving in
country and the importing country; international commerce
• delay in registration because of consular
Table 1 shows the status of implementation by
legalization requirements established by law in
CECMED of new or modified requirements of
several countries;
WHO´s updated guidelines.

Table 1. Implementation of WHO’s updated guidelines on the Scheme in Cuba

Updated guidelines Implementation in Cuba

Issuing a certificate of a pharmaceutical product (CPP)
The recommended time for the initial issuance For CPPs and copies the time allowed is 10 working
of the CPP is 30 working days and for copies, days. CPPs are issued in Spanish and Spanish/English,
20 days, promoting better practices and to avoid unnecessary translations.
greater efficiency.
The certifying authority should officially stamp CECMED officially stamps and dates any certificates
and date any certificates issued or certify them issued but, for the moment, it does not have in place
using a secure electronic system/electronic an electronic system for these operations, and it is not
certificate (e-certificate). yet ready for issuing e-certificates.
Every effort should be made to ensure that According to the current regulation (several pieces),
certificates and all annexed documentation are the CPP, as part of the legal documentation required
consistent with the version of the marketing for marketing authorization, must be legalized by the
authorization operative on the date of issue. Cuban Embassy.
Nevertheless, requesting authorities are
discouraged from introducing legalization
procedures or any form of authentication
procedures, such as notarization, embassy
legalization or apostilles that may cause the
undue delay of certificates.

5. Experiences from regulatory authorities and industry perspectives 7

 Main changes in the model CPP
1.Basic information. The brand name used in the foreign country, when
different, is included as declared by the applicant for
Name: ...if possible, the brand name for the
the CPP from the Cuban pharmaceutical industry.
foreign country as declared by the requester,
(if different); ...
2. Information on marketing authorization. The link with the information on the marketing
authorization of the product is available on CECMED´s
2.A.7. Web link to the product marketing
webpage www.cecmed.cu
authorization information (if available)
3. Information on manufacturing and The information exists and records are available,
inspections but it is difficult to retrieve. The current Registration
Certificate does not include all the information listed
3.1 List of names and addresses of the
in the guidelines. For full implementation, changes
manufacturing sites and activities
in the working procedures will need to be introduced
gradually, which presents a challenge.
Contact information
Stamp and date (electronic All contact information is available in CECMED, but
whenever possible). not yet in electronic format. A plan is underway to
include the electronic signature with the national
legal recognition.
Explanatory notes
(2) The requirements for good manufacturing GMP inspections conducted by CECMED are aligned
practices and quality control of with WHO’s updated guidelines.a,b
pharmaceutical products referred to in the
certificate are those included in WHO Good
manufacturing practices for pharmaceutical
products: main principles.a Recommendations
specifically applicable to biological products
have been formulated by the WHO Expert
Committee on Biological Standardization.b

a
Good manufacturing practices for pharmaceutical products: main principles (15).
b
WHO Good manufacturing practices for biological products (16).

Although there are many challenges to overcome • capacity-building for the all the staff involved
to comply with the revised guidelines of the in activities related to the Scheme, not only for
Scheme, the Cuban NRA considers them as a guide those who issue CPPs;
to improve efficiency and regulatory practices to • reorganizing the working routines to make the
facilitate access to medicines. information that could be included in CPPs
more easily available; and
Currently, CECMED is looking for ways to
• making regulation more flexible and open to
overcome the limitations identified, including
facilitate inclusion of new technologies and
them in the Institutional Development Plan and
security mechanisms for certifications as well
seeking collaboration opportunities to support
as to minimize legalization procedures to avoid
implementation. The activities include:
undue delays for the applicants for CPPs.

8 WHO certification scheme on the quality of pharmaceutical products

 verification for electronic certificates |
5.2 European Medicines Agency (EMA) European Medicines Agency). Any interested
party can always confirm the authenticity of the
Some highlights of EMA’s experience in
details of an e-certificate issued by EMA by entering
implementing the new version of WHO’s template
the unique certificate number and request number
for CPPs are summarized below.
(found on the first page of the certificate) in the
Certification was one of the first reliance tools online tool. The tool will then display the following
used in the regulatory area and remains a key eCPP details: importing country, medicinal
reliance tool for smart regulation. The purpose product/pharmaceutical form, date, signatory
of the EMA certification scheme is to confirm the and confirmation of validity. These details are
medicine’s marketing authorization status and that sufficient to verify that the eCPP has been issued
it complies with GMP standards. This is intended to by EMA. This information is available from the day
support the work of health authorities outside the following the issue of the eCPP by EMA. It is also
European Union (EU), facilitate trade and enhance important to highlight that e-certificates contain
trust in the evaluation of the quality, safety and an electronic signature and safety features in
efficacy of medicines. compliance with the EU regulation on electronic
transactions (eIDAS) to fully assure the integrity of
EMA has been issuing certificates based on the certificates in such a way that any subsequent
the WHO Certification Scheme for many years, unauthorized manipulation is detectable. All these
ensuring that they contain the information measures were put in place to increase confidence
recommended by WHO and are accepted by the in the authenticity of certificates and avoid the
authorities participating in the Scheme. need for further legalization and notarization.

As part of the EMA drive for digital Since 16 January 2023, EMA has been issuing
transformation, increased efficiency and going e-certificates in accordance with the latest version
green (reduction of paper usage and waste), the of the WHO template. The previous template used
Agency started to issue electronic certificates by EMA already contained much of the information
(eCPP) in March 2020. This ensured that EMA could included in this new version, so the transition
provide certificates during the COVID-19 pandemic did not represent a major change from previous
without any business disruption, facilitating practice.
regulatory compliance and timely access for
medicines in importing countries. Although the The main differences from the previous template
initiative was launched during the COVID-19 used by EMA are as follows:
pandemic, it was never intended as a temporary
• Certificates contain mutually exclusive parts
measure but a step forward in the digitalization
“2.A” – for the centrally authorized products and
of administrative procedures. Therefore, the
“2.B” – for products under consideration and
e-certificate has completely replaced the paper
Medicines 4-All products (formerly Article 58).
form, which is no longer in use. EMA will continue
Only the relevant section is shown in the
to issue certificates in electronic format in
certificate based on the status of the product
the future.
requested.
One of the main concerns raised by the authorities • Stating the marketing authorization holder
of importing countries in relation to e-certificates status in the certificate follows the same
is how to ensure their authenticity. For this lettering as that of the manufacturing sites
reason EMA launched the online verification and with more granularity than previously
tool, available from its website (Authenticity (section 2.A.3).

5. Experiences from regulatory authorities and industry perspectives 9

• Certificates include a hyperlink to EMA’s All the documentation published on EMA’s
webpage for the product where the latest website has been updated to reflect these
information, any recent press release or safety changes. An email address is available for queries
restriction can be found. Therefore, although related to certificates or concerns from importing
the product information is still attached, press countries. It can be used by authorities, marketing
releases or information on safety restrictions are authorization holders and any other interested
no longer attached. Any receiving authority can party (certificate@ema.europa.eu).
use this hyperlink to find the latest information
that has been published. EMA is always available to share its experience
in implementing the new template with any
• Expression of manufacturing activities: Each
issuing authorities.
manufacturing activity that is requested in
the application form has a corresponding
letter assigned to it and is stated as such in
the certificate, next to the name and address 5.3 Singapore Health Sciences
of the manufacturing site (no longer stated as Authority (HSA)
free text). Thus, the information is now more
specific, and description of the activities is Singapore HSA has been a party to the Scheme
harmonized. since 1994. CPPs are issued through an e-service
portal known as PRISM (Pharmaceutical
Other changes implemented simultaneously with Regulatory Information System), which has
the introduction of the new template include been in operation since the early 2000s. PRISM
the option for issuing the certificates in English, e-services offer users the convenience of carrying
Spanish, French or Portuguese language and in out transactions, such as pharmaceutical product
any combination thereof and they are no longer registration and dealers’ licence applications,
bound by space constraints as in the previous and allows them to search for related information
template. A full compilation of changes is available online.
on the website (Implementation of the new WHO
certificate template – compilation of changes). The CPP module of PRISM has the function of
pulling data from the pharmaceutical product
Communication with stakeholders was key during registration and dealer licence database and
the implementation of the new WHO template. populating the essential information in the
EMA actively participated in the discussions that predefined sections of the CPP template. After
led to the publication of the new WHO template verification of information, CPPs are generated
and active communication was maintained with by the system, eliminating the risk of errors
stakeholders (industry associations and receiving associated with manual data entry, and ensuring
authorities) on the expected implementation of secured and controlled printing of the certificates.
the new format, proposed changes and timelines. With the change in the CPP format as described
During the first 6 months of the implementation in WHO Technical Report Series 1033 (18), the
of the new format (starting on 16 January 2023), main challenge is the need to enhance the current
EMA issued more than 5900 electronic certificates PRISM to incorporate the revised CPP format. This
for more than 120 importing authorities. There is involves introducing new sections in the CPP and
no information on any certificate being refused in pulling information from the PRISM database to be
any importing country and no negative comments reflected in these new sections. Where the required
have been received from receiving authorities. information is not available in the PRISM database,
product registrants would need to file a variation
to their product registration.

10 WHO certification scheme on the quality of pharmaceutical products

HSA will continue to use the current PRISM to and efficiency of the CPP globally. IFPMA also
generate CPPs. The implementation approach engages with relevant partners on key industry
involves immediate action to continue issuing CPP issues.
the CPPs in the previous format, with additional
information included either in a free text field or as
an attachment to the certificate. In the short term, Modernization of the Scheme and eCPP
the PRISM would undergo enhancement to address
With the increasing number of CPPs required
the major revisions of the CPP format. Ultimately,
for regulatory submissions generating an
there are plans to develop a new computerized
administrative burden for both regulators and
system to generate CPPs in the revised format. This
industry, the next step is the move towards an
major project would require extensive effort due
eCPP. During the COVID-19 pandemic, the need
to the complexity of the system and is part of the
to maintain the critical service of issuing CPPs
long-term plan to provide CPPs in the new WHO
prompted regulators to start implementing the
format.
eCPP in line with the WHO Certification Scheme
and relevant regulations on electronic signatures.
Many regulatory authorities started issuing
5.4 Reflections from Industry – eCPPs (EMA, Health Canada, UK Medicines and
International Federation of Healthcare products Regulatory Agency, US
Pharmaceutical Manufacturers and Food and Drug Administration etc.), considering
the eCPP as a permanent solution, part of the
Associations (IFPMA)
move towards full digitalization of administrative
The IFPMA represents more than 90 innovative processes. Many NRAs are also accepting eCPP
pharmaceutical companies and associations applications. In the era of digitalization, as
around the world. The industry’s almost three CPP-dependent countries start to implement
million employees discover, develop and electronic submissions, dossiers and CPPs
deliver medicines and vaccines that advance submitted electronically should be more widely
global health. Based in Geneva, IFPMA has accepted. This is also reflected in the ICDRA 2021
official relations with the United Nations and recommendations, where eCPPs, e-signatures
contributes industry expertise to help the and digital submissions are listed as best practices
global health community improve the lives of introduced during the COVID-19 pandemic, which
people everywhere. should be maintained in the post-pandemic setting
and become the new normal.
Within IFPMA, the CPP Network gathers industry
perspectives on the topic of CPP. This network The use of eCPPs has several benefits for all
supports best practices and raises awareness of stakeholders. These have been described in detail
the purpose of WHO’s Certification Scheme, its in the IFPMA position paper on eCPP (19), which
applicability and opportunities or alternatives also includes proposals for implementation of a
in the registration and subsequent lifecycle complete CPP process.
management of innovative medicinal products
worldwide, as well as in the context of establishing
Role of CPP: key challenges and considerations
regulatory reliance.
CPPs and eCPPs should facilitate faster submission
IFPMA has continuously engaged with WHO
and approval of a marketing authorization,
and other relevant stakeholders towards
or other activities throughout the product
modernization of the Scheme to improve the use
lifecycle. Within the work of the CPP Network,

5. Experiences from regulatory authorities and industry perspectives 11

industry identified the following challenges CPP and eCPP as a reliance tool
and considerations related to the use of CPPs
and eCPPs. The CPP was established several decades ago and
is the oldest reliance tool. Over the years, the initial
• The timeframe for the provision of the proof intention of providing CPPs (which was a partial or
of approval by the reference agency (CPP or full substitute for the quality, safety and efficacy
alternative) by the sponsor in the context of (QSE) review), has sometimes been misinterpreted
the approval process should be kept flexible and by CPP-requesting authorities, which considered
ideally lead to accelerated, abridged or reliance- the CPP as yet another administrative document.
based assessments. The eCPP should facilitate
earlier submission and approval of a marketing The publication of two important documents:
authorization, and other activities throughout Guidelines on the implementation of the
the product lifecycle. WHO Certification Scheme on the quality of
• The authenticity and integrity assurance pharmaceutical products moving in international
of the CPP. Although it is important to ensure commerce (18) and Good Reliance practices in the
a CPP’s authenticity and integrity, there are regulation of medical products: high level principles
sometimes redundant local requirements and considerations, reemphasizes the role of the
that go beyond the Scheme’s provisions. For CPP as a reliance tool (3). The WHO Certification
instance, many CPP-requesting countries Scheme is referred to as a reliance mechanism,
require further legalization of CPPs. Local stipulating that the CPP should be used as a
requirements for legalization of eCPPs are not substitute for a full or partial QSE assessment for
supported by WHO and the recommendation is marketing authorization.
to remove the requirement for the notarization
Also, in its guidance on the Collaborative Procedure
or legalization of the eCPP either by apostille
for Accelerated Registration (14), WHO gives
or using consulate/embassy services, as this
additional recommendations for the appropriate
provides no additional value.
requirements for documents to be submitted
• The acceptance of the new electronic format.
depending on the assessment procedure
According to the eCPP survey conducted in 2022
performed by an NRA, including guidance on
jointly by IFPMA and the European Federation
whether there is a need to submit a CPP, and also
of Pharmaceutical Industries and Associations
at what point during the assessment procedure
there was limited experience of acceptance of
this should happen.
the new electronic format due to the limited
number of authorities issuing eCPPs at that
time. Also, many CPP-requesting countries face General comments
legal and technical challenges related to local
legislation and/or technical tools that are not The industry proposes that the following
ready for accepting electronic submissions, suggestions be considered for the future
including eCPPs. implementation of the WHO Certification Scheme:

IFPMA is working with all the stakeholders to • Utilize the CPP as a tool for reliance and
ensure awareness of the ways in which eCPPs eliminate additional supporting documents.
can be authenticated and accepted without • Link the use of the Certification Scheme
additional requirements. with WHO Global Benchmarking Tool (GBT)
assessment. Linking the issuance of CPPs
with the GBT maturity level will ensure that

12 WHO certification scheme on the quality of pharmaceutical products

 certification authorities are qualified to conduct regulatory operations for the oversight of medical
regulatory assessments and inspections. This products. The Certification Scheme unequivocally
alignment provides greater assurance to CPP- demonstrated its importance during the COVID-
requesting authorities regarding the product’s 19 pandemic, and the value of this established
quality, safety, and efficacy. tool is growing in the broader context of reliance.
• No CPP requirement should exist when a The eCPP should be fully integrated with other
complete QSE review is conducted by NRAs, as it digital systems used for dossier submission and
is redundant in this case. review, including e-signatures and electronic
dossier submissions. Legalization of the eCPP is
• All issuing NRAs should consistently implement
discouraged.
the revised WHO CPP template. If consistency
is seen from the issuing NRAs through
In conclusion, eCPPs will increase the efficiency
implementation of the WHO CPP template,
and the integrity of regulatory systems. For that
recipient NRAs will also see the benefits of
purpose, eCPPs should be recognized as a reliance
harmonization of CPP requirements.
tool by all stakeholders, and ultimately will lead to
faster access to medicinal products.
To sum up, reliance is an important means of
improving the efficiency and effectiveness of

5. Experiences from regulatory authorities and industry perspectives 13

6. Strengths and limitations of the
Certification Scheme
The WHO Certification Scheme has several using the WHO GBT, but this would necessitate
strengths. It provides a framework for Member a change of the initial concept of a voluntary
States to share information and establish reliance, agreement, and it was not accepted by all the
ensuring the safety, quality and efficacy of medical Member States. The fact is that, currently, the
products that are in circulation in their markets. CPP is as reliable as the regulatory maturity of the
issuing country allows. Another limitation is that
Nevertheless, the Scheme has some limitations. this Scheme does not cover active ingredients and
One of these is that, in some countries, the CPP excipients, which may have contributed to cases of
may be issued even though the manufacturer does contamination with dangerous substances, such as
not comply with GMP requirements. This highlights diethylene glycol, causing fatalities.
the need for a system for verifying that a Member
State issuing a CPP meets certain criteria that are
independently verified. Discussions have been
held on linking the Scheme to the assessments

14 WHO certification scheme on the quality of pharmaceutical products

7. The way forward
The Certification Scheme, being the oldest using the synergies in the current regulatory
established reliance mechanism, is a tool that ecosystem. It is also important to encourage
continues to be considered relevant by Member national authorities to make better use of
States and remains effective in protecting its potential as a reliance pathway, avoiding
public health. duplication of efforts and enabling faster access
to medicines.
The current changes to the Scheme maintain
the key principles that need to be addressed and In this process, WHO is committed to maintaining
implemented within a transformed regulatory its support to countries, clarifying issues related
ecosystem where the Scheme must coexist with to the implementation of the Scheme, promoting
other reliance mechanisms. Participating countries regulatory compliance, reliance and global
will take time to adjust as they will need to adapt cooperation. This in turn will contribute to
their regulatory frameworks and information preventing more tragedies related to substandard
systems to ensure compliance with requirements and falsified medicines as well as ensuring
for additional information and digital certificates. patient safety.

The way forward will certainly be to bridge the

gaps between the different reliance mechanisms,

15
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References 17
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