TRs 1060 - Annex 7: Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products
15 April 2025
| Technical document
Overview
This guideline is intended to serve as a best practice model for NRAs for implementing CRPs in their overall marketing authorization system for medical products, and it should be read in conjunction with the full text of the collaborative procedures (4–6). The document also outlines the recommended approaches an NRA should take to process different types of applications, based on prior decisions and documentary evidence from the WHO Prequalification Unit or WLAs.
WHO Team
Access to Medicines and Health Products (MHP),
Health Product Policy and Standards (HPS),
Norms and Standards for Pharmaceuticals (NSP),
Technical Standards and Specifications (TSS)
Number of pages
64