The WHO Prequalification Unit (PQT) is pleased to announce the successful submission of its first eCTD formatted dossier for API Prequalification via the recently opened ePQS Portal.
The WHO Prequalification Unit is pleased to announce the successful submission of its first eCTD formatted dossier via the recently opened ePQS Portal.
The PQT Medicines Annual Quality Assessment Training for regulators will take place from 9 to 12 June 2025.
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
We are pleased to announce that two additional MPXV tests have been listed under WHO's Emergency use listin
The WHO Prequalification (PQT) Unit is pleased to announce the opening of the ePQS portal to external users on 19 May 2025.
WHO is pleased to announce the publication of the revised guidan
WHO is pleased to announce that the Prequalification of in vitro diagnostics programme has been expanded to point-of-care analysers intended for:
Dolutegravir (sodium) manufactured by Styrax Pharma Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
On 27 March WHO prequalified one additional in vitro diagnostic, the
WHO Prequalification Inspection Services performed an on-site for-cause inspection on Mylan’s Pithampur manufacturing site from 3 to 7 March 2025.
Nirmatrelvir manufactured by DongBang Future Tech & Life Co., Ltd.
According to WHO’s Procedure for prequalification of pharmaceutical products (TRS 961, Annex 10), “WHO recognizes the evaluation of relevant
The following API was added:
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
A first invitation to manufacturers of medicinal products for treatment of bacterial infections in children, to submit an Expression of Interest (EOI) for product evaluation has been published by t
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
A first invitation to manufacturers of Mycobacterium tuberculosis antigen-based skin tests (TBSTs), to submit an Expression of Interest (EOI) for product evaluation has been published by the WHO Pr
Albendazole (WHOAPI-427) manufactured by Sequent Scientific Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
TB395 Bedaquiline fumarate Tablet 100mg - MSN Lab - INDIA
Dihydroartemisinin manufactured by Guilin Pharmaceutical Co., Ltd.
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO Prequalification Unit (PQT) added the below new products to its prequalified list: