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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.

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

New WHO Public Inspection Reports (WHOPIRs) were published today:

This survey aims to gather feedback on the updated PQDx 121 guidance, the new change request submission form, and the overall submission and assessment process.

WHO is pleased to announce that the Prequalification of IVDs programme scope has been expanded to the following types of products:  

On 18th December the Loopamp MTBC Detection Kit manufactured by Eiken Chemical Co., Ltd. was prequalified.

Levonorgestrel manufactured by Jiangsu Lianhuan Pharmaceutical Co., Ltd.

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

The Prequalification of IVDs Q4 2025 Newsletter has been posted on the website.

Related links:  

For the first time, two SARS-CoV-2 antigen detection rapid tests have successfully transitioned from WHO’s Emergency Use Listing (EUL) to WHO Prequalification (PQ):

On 17 December 2025 the Assessment of Medical Devices Team held a webinar for stakeholders to introduce changes which will be implemented to the prequalification assessment

WHO recently hosted a successful workshop in The Westin Guangzhou, Guangzhou, China, bringing together over

The Monkeypox Virus (MPXV) Fast Real Time PCR Kit manufactured by Jiangsu Bioperfectus Technologies Co., Ltd.

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