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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

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:

WHO has prequalified the Determine™ Syphilis Advanced

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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.