PQT/MED currently has two major prequalification pathways – the full assessment pathway for generics not approved by a Stringent Regulatory Authority (SRA), and the abridged prequalification pathway for products that have been approved by an SRA*.
Given WHO's initiative to assess and publicly designate national regulatory authorities (NRAs) as WHO Listed Authorities (WLA) or as being at maturity level 3 or 4 (ML 3 or ML 4 NRAs), new opportunities are emerging to expand reliance-based prequalification pathways. Consequently, a revised prequalification procedure - Procedure for prequalification of pharmaceutical products - has been issued to introduce these new pathways. This revised procedure is available for public consultation under the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP): https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/2025-04-02_pq-procedure-_revised_01.pdf?sfvrsn=bf98c403_3
To provide further detail PQT/MED has prepared a guidance document for pilot implementation outlining how PQT/MED intends to implement the reliance-based prequalification pathways described in the revised prequalification procedure.
This additional guidance describes how PQT/MED intends to expand collaborations with WLAs and ML3/4 NRAs for the purpose of prequalifying products approved by these NRAs.
Stakeholders are invited to provide comments on the draft guidance note. Any comments should be sent to Dr. Matthias Stahl, Team Lead PQT/MED, (stahlm@who.int) by 30 September 2025.
*Note: Additionally, PQT/MED has an alternative listing procedure whereby products approved by SRAs for use outside of the SRA region can be included in the list of prequalified products (under the SRA reference number).
As an option to the alternative listing procedure PQT/MED recently issued additional guidance on the expansion of the abridged prequalification procedure to permit formal prequalification of such “export only” products (with the assignment of a WHO reference number).