WHO: TRS 1060 regulatory Guidelines published

In April 2025, the WHO published the new guideline package TRS 1060 on its website - see also an overview of the main topics of the associated Annexes 2 to 9 in the news item 'New WHO Guideline Package: TRS 1060 published". These include 'TRS 1060 - Annex 7: Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products' and 'TRS 1060 - Annex 8: Collaborative registration procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products'. Both annexes are thematically assigned to the regulatory subject areas and are explained below.

TRS 1060 - Annex 7: Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products

This new guideline contains recommendations for national authorities on collaboration during the registration of medicinal products and is divided into the following main chapters and annexes:

Abbreviations
1. Introduction
2. 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 Verification review or abridged or abbreviated review of pharmaceuticals or vaccines submitted under the WHO collaborative registration procedure
Appendix 3 Abridged or abbreviated review of WHO-prequalified in vitro diagnostic medical devices submitted under the WHO collaborative registration procedure
Appendix 4 Additional information to be included in the screening checklist
Appendix 5 Model acknowledgement or approval letter for variations of products registered through the WHO collaborative procedure

Chapters 5 and 6 of 'TRS 1060 - Annex 7: Best practices of national regulatory authorities in the implementation of cooperative registration procedures for medical devices' are each divided into subchapters.

TRS 1060 - Annex 8: Collaborative registration procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products

This Annex 8 of TRS 1060 is an updated version of the Annex 8 of the "TRS 996 Collaborative procedure between the World Health Organization (WHO) Prequalification Unit and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines" from 2016 and now also specifically lists vector products.
The main chapters and appendices of the directive are listed below:

Background
1. Introduction
2. Scope
3. Glossary
4. Principles and general considerations
5. Steps in the collaboration for national registration of a prequalified VCP
6. Collaboration mechanisms for post-prequalification or post-registration variations or changes
7. Withdrawal, suspension or delisting of prequalified VCPs and national deregistration
References
Appendix 1 National regulatory authority participation agreement and undertaking
for national regulatory authority focal points
Appendix 2 Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the Procedure
Appendix 3 Expression of interest to national regulatory authority (NRA) in the assessment and accelerated national registration, acceptance by NRA and notification of Procedure outcomes 4
Appendix 4 Report on post-registration actions in respect of a product registered under the Procedure

Chapters 1 and 4 each contain subchapters.

On the WHO website you can find Annex 7 and Annex 8 of TRS 1060.