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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 has published an update on the status of ongoing Emergency Use Listing (EUL) applications for in vitro diagnostics (IVDs) for Bundibugyo virus disease (BDBV).

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.

A WHO workshop brought together manufacturers of IVDs, to advance access to quality-assured diagnostics, with a focus on strengthening understanding of prequalification req

WHO has published detailed submission instructions for the Emergency Use Listing (EUL) of in vitro diagnostics for Bundibugyo virus disease (BDBV)

• Public Report for Aptima HPV 16 18/45 Genotype Assay, (PQDx 0634-078-00)

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.

WHOAPI-431 (Albendazole) manufactured by Rakshit Drugs Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.

WHO has prequalified the cobas® MTB‑RIF/INH assay, confirming its compliance with international quality, safety, and performance requirements under the WHO Prequalification progra

A training for assessors is being conducted at the WHO Academy in Lyon from 21 to 24 April 2026 to strengthen capacity for the WHO prequalification of in vitro diagnostics (IVDs).

The cobas® MTB test by Roche Diagnostics has been added to the WHO Prequalification list, supporting access to quality‑assured molecular tuberculosis diagnostics.

WHO will hold a Prequalification Workshop for manufacturers of in vitro diagnostics (IVDs) from 8–10 June 2026 at WHO headquarters in Geneva.

Between 1 March and 16 April 2026, several WHO Public Assessment Reports (WHOPARs) were updated to reflect changes in product l

The WHO Prequalification Unit is expanding its scope and is establishing a roster of consultants to s

WHO Prequalification has listed three malaria rapid diagnostic tests: 

• BIOCREDIT Malaria Ag Pf (pLDH)

In 2026 more frequent dossier assessment sessions have been planned to facilitate timely review of IVD product dossiers and corrective

Lamivudine manufactured by Arene Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.

Tenofovir disoproxil fumarate manufactured by SMS Pharmaceuticals Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.

The purpose of this Request for Quotations (RFQ) is to enter into a contractual agreement with a successful bidder and select a suitabl

WHO Prequalification Unit (PQT) added the below new product to its prequalified list:

Access to affordable insulin remains a critical public health priority.

WHO Prequalification Unit (PQT) added the below new product to its prequalified l

WHO Prequalification Unit (PQT) added the below new product to its prequalified l

WHO Prequalification Unit (PQT) added the below new product to its prequalified l

The journey began 25 years ago in 2001 with the guiding motto “working for countries, with countries,” marked by the convening

Darunavir (ethanolate) manufactured by Arene Life Sciences Private Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.

• Cipla Ltd, Plot D-27, Unit II - Desk Assessment

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.