News

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

The Collaboration for Global Health

The following API was deleted: 

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

WHO’s Prequalification of In Vitro Diagnostics

During the week of 27–31 October 2025, the World Health Organization (WHO) publ

Cowingene Monkeypox Typing Detection Kit, manufactured by Taizhou Cowingene Biotech Co., Ltd., has been listed under the WHO Emergency Use Listing (EUL).

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These assays - Aptima HPV 16 18/45 Genotype Assay and the Aptima HPV Assay provide advanced nucleic acid amplification technology for detecting high-risk HPV type

In September 2023, PQT/MED issued a call to manufacturers to revisit and update their risk assessments for Finished Pharmaceutical Products (FPP) containing APIs with vulnerable amine groups.

The PQT/AMD team has added a new product to the Emergency Use Listing (EUL):

During the week of 20–24 October 2025, the World Health Organization (WHO) published updates to several WHO’s Public Assessment Reports (WHOPARs) on its In Vitro Diagnostics (IV

The PQT Medicines 8th Annual Medicines Quality Workshop for Manufacturers will take place from 27 to 30 October 2025.

In a continuing effort to best support the MPXV response, the Prequalification Unit has listed the Monkeypox Virus

The World Health Organization (WHO) has prequalified the Xpert MTB/XDR test, a quality-assured molecular diagnostic tool that enables rapid drug susceptibility testing (DST) for tuberculosis (TB).

WHO has prequalified two more products:

The BD Onclarity™ HPV Assay for the BD COR™ System is an amplified DNA test for the qualitative dete

A core component of the Prequalification assessment process relates to technical review of the product dossier and change requests.

Gilead’s Lenacapavir Tablet and Injection Products Prequalified by WHO

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

The 2025 UNFPA-UNICEF-WHO Annual Meeting is taking place online from 29 September to 3 October 2025.  The theme of the 2025 Joint Meeting was “Delivering in times of D

On 17 September 2025, the Monkeypox Virus Lyo-PCR Kit, manufactured by Shanghai ZJ Bio-Tech Co., Ltd, was listed as an additional in vitro diagnostic under the Emergency Use Listi

On 17, 18 and 19 September 2025, the WHO Prequalification Unit, Medicines Assessment Team is organizing a Training for African Assessors and EMP-TC Members under AMRH and the future African Medicin

An additional in vitro diagnostic has been listed under the Emergency Use Listing procedure.

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