Good practices of national regulatory authorities - Annex 6

Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products - Annex 6

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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) 

References 

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

Appendix 2  VerificationforproductsubmittedundertheWHOcollaborativeprocedure 

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 

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).

Good practices of national regulatory authorities - Annex 6