Good Practices of National Regulatory Authorities in Implementing the Collaborative Registration Procedures for Medical Products. WHO Technical Report Series, No. 1019, 2019, Annex 6
(2019; 53 pages)

Abstract

This guideline is focused mainly on the collaborative procedure for WHO-prequalified pharmaceutical products and vaccines and the collaborative procedure for pharmaceutical products and vaccines approved by SRAs. In addition, the principles, practical steps and tools described in this guideline may apply to a stand-alone setting outside the collaborative registration approach, for example, where the NRA specifies other authorities as reference authorities for its own reliance purposes. Although, the published Procedures apply for pharmaceutical products and vaccines, the general principles may also apply to medical devices, including in vitro diagnostics, for which the collaborative procedure guideline is under development.

This document provides recommendations to NRAs that are participating in the Procedures. Nonetheless, reliance or risk-based approaches follow the principles of good regulatory practices (GRP) and are also applicable and practised among the well-resourced and mature regulatory agencies. This enables a greater alignment and convergence with international standards for the NRAs, while they can also maximize efficient use of their own resources. Moreover, the NRAs are able to focus on value-adding activities and therefore reduce the burden of duplication of work done by trusted authorities and duplication of work for applicants/manufacturers.

In the case of national applications for registration of products assessed and prequalified by WHO or registered by reference authorities, it is possible that national applications can be submitted by other persons/legal entities that act on behalf of manufacturers with WHO-prequalified products or products approved by reference authorities. It is necessary to consider these options, and existing CRPs includes arrangements for such situations. If the applicant for national registration is not the same as the manufacturer with the WHO-prequalified or reference authority-approved product, the manufacturer with the WHO-prequalified or reference authority-approved product confirms to the NRA and WHO/reference authority by an authorization letter that the applicant is acting for, or pursuant to rights derived from, the manufacturer with the WHO- prequalified or reference authority-approved product and that they agree with the application of the procedure in the country concerned.

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