Publication of updated Guidance and Application Form for Reportable changes to WHO prequalified and emergency use listed in vitro diagnostics
IVD
WHO is pleased to announce the publication of the revised guidan
Prequalification of IVDs scope expanded to haemoglobin PoC analysers
IVD
WHO is pleased to announce that the Prequalification of in vitro diagnostics programme has been expanded to point-of-care analysers intended for:
Active Pharmaceutical Ingredient (API) Prequalified
M
Dolutegravir (sodium) manufactured by Styrax Pharma Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Two PQT Medicines trainings for regulators
M
The PQT Medicines Annual Quality Assessment Training for regulators will take place from 9 to 12 June 2025.
A new HPV assay prequalified by WHO
IVD
On 27 March WHO prequalified one additional in vitro diagnostic, the
Active Pharmaceutical Ingredient (API) Prequalified
M
Nirmatrelvir manufactured by DongBang Future Tech & Life Co., Ltd.