According to WHO’s Procedure for prequalification of pharmaceutical products (TRS 961, Annex 10), “WHO recognizes the evaluation of relevant products by SRAs which apply standards for quality equivalent to those recommended by WHO.” Indeed, since the start of WHO’s Prequalification Programme, products could be prequalified based on their SRA status and according to WHO’s Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities (SRA guideline). Similarly, products approved by SRAs for export only purposes have been included in the list of prequalified products based on the alternative listing procedure
The current SRA guideline and its abridged procedure for prequalification of SRA approved products and the alternative listing procedure for export only products, however, do not support facilitation of national registrations utilizing WHO’s Collaborative Registration Procedure (CRP) due to the absence of full PQT/MED assessment and inspection reports for sharing in the context of CRP.
Based on the experience of the above abridged procedure and comments from stakeholders, PQT/MED aims to make products prequalified based on SRA approval eligible for CRP as prequalified products, thereby facilitating their national registrations. The new guideline can be found at Procedure to enable national registration of products prequalified based on SRA approval utilizing WHO’s Collaborative Registration Procedure for prequalified products.
To allow for prequalification of products approved by SRAs for export only purposes and make such products eligible for national registration utilizing CRP for prequalified products a further guideline has been drafted. The new guideline can be found at Procedure to enable prequalification of products approved by SRAs for use outside the SRA region.
Both the above procedures will be piloted in an initial phase. Stakeholders are invited to provide comments on the corresponding draft guidelines. Any comments should be sent to Dr. Matthias Stahl, Team lead, (stahlm@who.int) by 30 June 2025.
Note: All SRAs are being transited to the WHO Listed Authorities (WLA) list based on abbreviated performance evaluation such that the term SRA is replaced with WLA. The above stated new guidelines apply only for products approved by SRAs/WLAs that have supported prequalification of products over a long time based on the abridged procedure (i.e., EMA, BfArM, MHRA, MPA, CBG/MEB, Swissmedic, TGA, FAMHP and USFDA). A separate guideline for prequalification of products approved by other WLAs is to be issued.