The In Vitro Diagnostics Assessment Team has published the Q2 2025 Newsletter summarizing the main news. 

You can access the New

We have been informed that, as part of the implementation of the

All applicants should note that all post PQ and EUL Change Request applications must now be submitted exclusively via the

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 (WHO IMD-PQS) is delighted to announce the opening of the NEW WHO e-Prequalification System (ePQS) – an online por

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

Rifampicin (WHOAPI-520) manufactured by Hebei Xingang Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.

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

PQT/MED currently has two major prequalification pathways – the full assessment pathway for generics not approved by a Stringent Regulatory A