WHO TRS (Technical Report Series) 1019, 2019 Annex 6


WHO TRS (Technical Report Series) 1019, 2019 Annex 6

Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products

1. Background:

In 2014, the 67th World Health Assembly resolution, WHA67.20, recognized that effective regulatory systems are an essential component of health  system strengthening and contribute to better public health outcomes, that regulators are an essential part of the health workforce, and that inefficient regulatory systems themselves can be a barrier to access to safe, effective and quality medical products (1).

Nonetheless, regulators, globally, and in particular low- and middle-income countries, face an increasingly complex regulatory environment, with limited resources and a need to avoid duplication by communicating, collaborating, cooperating and forming coalitions to ensure product quality, safety and efficacy, as well as supply-chain security.

To this end, collaborative registration procedures (CRPs) with a view to accelerating national registrations and the regulatory life-cycle of products prequalified by the World Health Organization (WHO), or approved by reference stringent regulatory authorities (SRAs), have been developed and implemented (2, 3). Based upon WHO’s experience with the collaborative procedure for WHO prequalified pharmaceutical products and vaccines (2), and the pilot collaborative procedure of products approved by SRAs (3), it is possible to facilitate and accelerate national registration processes using this approach in the management of registrations and post-registration regulatory product life cycle, based on reliance on the expertise and regulatory outcomes of recognized reference authorities.

Available assessment and inspection reports of reference SRAs or the WHO Prequalification Team (PQT), in addition to the registration dossiers, can facilitate and accelerate the adoption of national regulatory decisions by assuring national regulatory authorities (NRAs) of the positive benefit–risk of a product and its identical quality with the product already approved elsewhere, while allowing them to reflect their own judgement on the benefit–risk balance as it relates to their specific country situation and the legislation in place. This contributes substantially to savings in regulatory resources, improvements in the quality of regulatory decisions and faster availability of needed therapies for patients.

Click on the following title for full details: pdf

Table of Contents

1. Background 

2. Aims and objectives 

3. Scope 

4. Glossary 

5. Key principles 

6. Essential elements of a registration system (in the context of collaborative registration procedures) 


Appendix 1: An example of information to applicants for registration via the WHO collaborative registration procedure

Appendix 2: Verification for product submitted under the WHO collaborative procedure

Appendix 3: Abridged/abbreviated review for product submitted under the WHO collaborative procedure 

Appendix 4: Additional information to be included in the screening checklist 

Appendix 5: Example of a national regulatory authority reliance model approach: information, documentary evidence and assessment activity

Appendix 6: Model acknowledgement or approval letter for variations of products registered through the WHO collaborative procedure

WHO TRS (Technical Report Series) 1019, 2019 Annex 6:

Post a Comment


Post a Comment (0)