The third IVDs assessment session in 2025 successfully completed
IVD
The third assessment session for in vitro diagnostics in 2025 took place from 16 to 20 June 2025 in a fully virtual format.
WHO Immunization Devices prequalification announces the opening of the WHO e-prequalification system (ePQS) & Immunization Devices website
ID
WHO Immunization Devices prequalification (WHO IMD-PQS) is delighted to announce the opening of the NEW WHO e-Prequalification System (ePQS) – an online por
FAQs and Key Updates on the New Change Request Process for Prequalified and EUL IVDs
IVD
This edition features a brief Q&A addressing the most common questions related to the updated Change Request (CR) application process for in vitro diagnostics listed un
Active Pharmaceutical Ingredient (API) Prequalified
M
Rifampicin (WHOAPI-520) manufactured by Hebei Xingang Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Virtual meeting held with Prequalification of IVDs PELs
IVD
A virtual meeting of Performance Evaluation Laboratories (PELs) was organized on 28 May 2025 to introduce the new procedure for WHO’s performance evaluation of in vitro diag
Expanded reliance mechanisms
M
PQT/MED currently has two major prequalification pathways – the full assessment pathway for generics not approved by a Stringent Regulatory A