WHO Academy, Lyon, France | 9-12 November 2026
The WHO Prequalification Unit (PQT) has launched eCTD submission capability through the ePQS Portal.
The WHO Prequalification Assessment of Medical Devices (PQT/AMD) is seeking Request for Quotations (RFQs) from interested Notified Bodies to assist in technical documentation review activities for
WHO Prequalification Unit (PQT) added the below new product to its prequalified l
WHO Prequalification Unit (PQT) added the below new products to its prequalified
WHO Prequalification Team - Medicines (PQT/MED) has issued an updated version of its guidance on the recommended style to be used for visual description of oral dosage forms in WHOPARs.
Lamivudine manufactured by Jiangxi Desano Pharmaceutical Co. Ltd. has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Bedaquiline (fumarate) manufactured by Arene Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Effective 1 September 2026, WHO is expanding the scope of its prequalification programme for in vitro diagnostics (IVDs) to include:
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO Prequalification is expanding its scope to include Interferon-Gamma Release Assays (IGRAs) and targeted Next-Generation Sequencing (tNGS) assays for tuberculosis diagnos
Pyrazinamide manufactured by Resonance Specialities Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
A 43rd invitation to manufacturers of Active Pharmaceutical Ingredients (API) to submit an Expression of Interest (EOI) for API evaluation to the WHO Prequalification of Medicine
The first Invitation to Manufacturers of Medicinal Products for the Treatment of Childhood Cancer to submit applications for evaluation under the WHO Prequalification Programme has been issued foll
The RealStar Filovirus Screen RT-PCR Kit 1.0, manufactured by Diagnostics GmbH, and the RADIONE Ebola/Marburg Detection Kit, manufactured by KH Medical Co., Ltd., have now received WHO Emergency Us
Ritonavir manufactured by Qidong Dongyue Pharmaceutical Co., Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
The following APIs were added:
Between 20 June and 21 July 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product labelling, documentation, and other relevant post-prequ
The 1st Invitation for the submission of medicinal products for the treatment of Sickle Cell Disease for product evaluation by prequalification has been issued, based on a reques
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Dolutegravir (sodium) manufactured by M/s.
Between 27 May and 19 June 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product labelling, documentation, and other relevant post-prequa
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:
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
The World Health Organization Prequalification Teams - Medicines Assessment and Inspections - will be attending the Shanghai SNIEC CPhi on 16-18 June 2026, in Shanghai, China.
The World Health Organization (WHO), through its Department of Regulation and Prequalification, provides guidance to the United Nations Children’s Fund, other interested United Nations agencies, Me
Between 17 April and 27 May 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product labelling, documentation, and other relevant post-prequ
The following APIs were added:
The 1st Invitation to manufacturers of medicinal products for treatment of substance use disorders to submit an application for product evaluation by prequalification has been issued based on a req
The Invitation to Manufacturers of human insulin and insulin analogues was recently updated and renamed as Invitation to Manufacturers of medicinal products for management of diabetes to Submit an
Amodiaquine (hydrochloride) manufactured by Anuh Pharma Ltd. has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
