WHO TRS 1010, 2018 Annex 11

WHO TRS (Technical Report Series) 1010, 2018 Annex 11

Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities - Annex 11

Click on the titles below for complete guidelines

TABLE OF CONTENTS

1. Background information 

2. Glossary

3. Principles of collaborative procedure 

4. Medicines 

5. Collaboration mechanisms for management of post-registration variations 

Appendix 1  Agreement of the national regulatory authority to participate in the collaborative procedure in assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities 

Appendix 2  Example of information included in the list of participating reference stringent regulatory authority(ies) 

Appendix 3A  Manufacturer’s consent for information sharing with participating national regulatory authority(ies) and the World Health Organization 

Appendix 3B  Manufacturer’s request for stringent regulatory authority’s (SRA’s) permission for sharing SRA-owned non-public information with participating national regulatory authority(ies) and the World Health Organization 

Appendix 4  Quality information summary of the finished pharmaceutical product or vaccine approved by the reference SRA (QIS- SRA (crp)) 

Appendix 5  Proposed documentation for collaborative procedure for reference SRA-approved pharmaceutical products and vaccines 

Appendix 6  Requirements for provision of a bridging report for reference SRA-approved pharmaceutical product and vaccines for consideration of registration in participating countries 

Appendix 7  Expression of interest to national regulatory authority 

Appendix 8  Confidential disclosure agreement 

Appendix 9  Notification of an outcome of the national registration provided by the participating manufacturer to the World Health Organization 

1. Background information

Management of diseases known to be of major relevance to public health in countries with limited regulatory resources is often jeopardized by delayed access to new or needed therapies. Although many medicines successfully pass a regulatory review process conducted by internationally respected regulatory bodies, also known as stringent regulatory authorities (reference SRAs), or may in addition have been prequalified by the World Health Organization (WHO), local regulatory approvals tend to consume additional time and resources of national regulatory authorities (NRAs) before these therapies can be made available to patients.

WHO TRS (Technical Report Series) 1010, 2018 Annex 11