WHO Releases TRS 1060 Guidelines on Collaborative Registration Procedures

In April 2025, the World Health Organization (WHO) published its new Technical Report Series (TRS) 1060, including Annexes 7 and 8, which provide updated guidance for national regulatory authorities (NRAs) on collaborative registration processes.

Annex 7 outlines best practices for NRAs in registering medical products through collaborative procedures. It covers objectives, scope, key principles, and essential system elements, with appendices offering templates, checklists, and review processes for pharmaceuticals, vaccines, and in vitro diagnostic devices.

Annex 8 updates the 2016 TRS 996 guidelines, extending the collaborative registration framework to WHO-prequalified vector control products. It details steps for national registration, post-registration changes, and procedures for suspension or withdrawal. Appendices include agreements, consent forms, and reporting templates.

These annexes aim to streamline regulatory processes, accelerate product availability, and strengthen cooperation between WHO and NRAs. Full texts are available on the WHO website.

10-08-2025