WHO TRS (Technical Report Series) 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

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.

To address this issue, WHO proposes a scheme for NRAs and pharmaceutical manufacturers to facilitate registrations of the vaccines and pharmaceutical products, including biotherapeutic products approved by reference SRAs. WHO recognizes the scientific evaluation of medicines by reference SRAs as they apply similarly stringent standards for quality, safety and efficacy to those recommended by WHO.

Based on WHO experience with the Collaborative procedure of WHO prequalified pharmaceutical products and vaccines, it is possible to facilitate and accelerate national registration processes by provision of detailed assessment and inspection outcomes generated by respected regulatory bodies. Assessment and inspection reports of reference SRAs made available in addition to the registration dossiers can facilitate the adoption of national regulatory decisions by assuring NRAs about the positive risk–benefit profile of a product and that its quality is identical with the product already approved elsewhere. 

Normally, publicly available versions of assessment and inspection outcomes do not provide all the necessary information in sufficient detail to enable regulatory decisions to be adopted. Therefore, detailed assessment and inspection outcomes that include commercially sensitive data must be shared. Whether to make such information sharing possible is up to interested pharmaceutical manufacturers, which should provide consent to information exchange among reference SRAs and NRAs, to which a product is submitted for regulatory approval. Pharmaceutical manufacturers benefit from accelerated and facilitated regulatory processes. For their part, it is up to interested NRAs to provide sufficient assurance that shared data will be treated with necessary care and respect for confidentiality. Nonetheless, in some jurisdictions, publicly available information such as public assessment or inspection reports, and databases of compliance with good manufacturing practices (GMP) contain substantial summarized regulatory information that can facilitate the decision-making process in less well-resourced NRAs as well.

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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

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

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