Desogestrel (WHOAPI-479) manufactured by Hunan KYF Pharmaceutical Co. Ltd. has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
The invitation to Manufacturers of Antimalarial Medicines to submit an Expre
The Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interes
Lamivudine, manufactured by SMS Pharmaceuticals Limited, has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
The survey on the updated Post PQ Change Request process and PQDx 121 guidance shows that manufacturers are broadly satisfied with recent improvements to the system.
WHOAPI-429 (tenofovir disoproxil fumarate) manufactured by Styrax Pharma Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
A Position Note on Accessories has been published by the Assessment of Medical Devices Team.
New WHO Public Inspection Reports (WHOPIRs) were published today:
On 11 February 2026 WHO published an amended invitation to manufacturers of Monkeypox virus IVDs
The ePQS Portal is the externally-facing Salesforce Community site of the WHO Prequalification Unit’s new ePQS system.
WHO has added the Measles Vaccine (Live) (Attenuated, Freeze-Dried) to its list of prequalified vaccines
New WHO Public Inspection Reports (WHOPIRs) were published today:
WHO is pleased to announce that the Prequalification of IVDs programme scope has been expanded to the following types of products:
A Notice of Concern (NOC) has been published by the World Health Organization (WHO), through its Prequalification Unit (PQT), for Meril Diagnostics Pvt Ltd.
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Levonorgestrel manufactured by Jiangsu Lianhuan Pharmaceutical Co., Ltd.
Effective 1 January 2026, the WHO Prequalification Programme will introduce an annual 10% increase on all applicable fees that have remained unchanged since 2017.
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
The invitation to Manufacturers of Antimalarial Medicines to submit an Expression of Interest for Product Evaluation to t
The following API was deleted:
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
In September 2023, PQT/MED issued a call to manufacturers to revisit and update their risk assessments for Finished Pharmaceutical Products (FPP) containing APIs with vulnerable amine groups.
The PQT Medicines 8th Annual Medicines Quality Workshop for Manufacturers will take place from 27 to 30 October 2025.
Gilead’s Lenacapavir Tablet and Injection Products Prequalified by WHO
