AMA training
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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
News
WHO launches a pilot parallel WHO Prequalification and TB policy assessment process for new TB IVDs
IVD
To streamline and optimize WHO assessment of new in vitro diagnostics, the WHO Prequalification Unit (PQT) within the Department of Regulation and Prequa
Announcement of the opening of the WHO e-Prequalification System (ePQS) for immunization device prequalification
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WHO Immunization Devices prequalification (WHO IMD-PQS) is delighted to announce the opening of t
Artesunate powder for solution for injection 30 mg, an additional strength involving a single solvent system
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Macleods’ miltefosine 50 mg capsule prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO prequalifies first two spatial emanator products for use in vector control
VCP
WHO has prequalified the first two spatial emanators products, Mosquito Shield and Guardian, manufactured by SC Johnson & Son, Inc., alongside t
WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination goals
IVD
On 10 July 2025, the World Health Organization (WHO) prequalified the first bundled set of three in vitro rapid diagnostic tests (RDTs) capable of simultaneously detecting HIV, hepatitis B virus (H
WHO Prequalifies First Antigen-Based TB Skin Test: A Milestone for Detection of TB Infection Globally
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ pediatric dispersible dolutegravir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shanghai Desano’s emtricitabine/tenofovir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Ipca’s primaquine tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Active Pharmaceutical Ingredient (API) Prequalified
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Dolutegravir sodium (WHOAPI-445) manufactured by Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.
39th Invitation of Active Pharmaceutical Ingredients (APIs)
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The following API was added:
WHO prequalifies the first triple diagnostic test
IVD
WHO has granted the first prequalification listing of a bundle of three diagnostics tests to be used for pregnant women for the qualitative detection of HIV, Hepatitis B Surface Antigen, and Trepon
23rd Invitation to Manufacturers and Suppliers of Medicinal Products for HIV Infections and Related Diseases to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit
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The 23rd EOI for HIV/AIDS Products includes the addition of a co-pack of Cabotegravir extended-release intramuscular injection + Rilpivirine extended release intramuscular injection, as well as the
Active Pharmaceutical Ingredient (API) Prequalified
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Rifampicin form I (WHOAPI-521) manufactured by Hebei Xingang Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Pediatric artemether/lumefantrine tabl from Velvet Med-Healthcare Solutions prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s pediatric abacavir/dolutegravir/lamivudine dispersible tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s pediatric dispersible linezolid tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
- TB409 Linezolid 150mg dispersible - Lupin Limited – INDIA
Macleods’ pediatric rifapentine dispersible tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Q2 2025 Newsletter
IVD
The In Vitro Diagnostics Assessment Team has published the Q2 2025 Newsletter summarizing the main news.
You can access the New
The third IVDs assessment session in 2025 successfully completed
IVD
The third assessment session for in vitro diagnostics in 2025 took place from 16 to 20 June 2025 in a fully virtual format.
WHO Immunization Devices prequalification announces the opening of the WHO e-prequalification system (ePQS) & Immunization Devices website
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WHO Immunization Devices prequalification (WHO IMD-PQS) is delighted to announce the opening of the NEW WHO e-Prequalification System (ePQS) – an online por
FAQs and Key Updates on the New Change Request Process for Prequalified and EUL IVDs
IVD
This edition features a brief Q&A addressing the most common questions related to the updated Change Request (CR) application process for in vitro diagnostics listed un
First eCTD application for Active Pharmaceutical Ingredient (API) Prequalification received at WHO PQT via the ePQS Portal
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The WHO Prequalification Unit (PQT) is pleased to announce the successful submission of its first eCTD formatted dossier for API Prequalification via the recently opened ePQS Portal.
First eCTD application received at WHO PQT via the ePQS Portal
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The WHO Prequalification Unit is pleased to announce the successful submission of its first eCTD formatted dossier via the recently opened ePQS Portal.
Two PQT Medicines trainings for regulators
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The PQT Medicines Annual Quality Assessment Training for regulators will take place from 9 to 12 June 2025.
Active Pharmaceutical Ingredient (API) Prequalified
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Rifampicin (WHOAPI-520) manufactured by Hebei Xingang Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Virtual meeting held with Prequalification of IVDs PELs
IVD
A virtual meeting of Performance Evaluation Laboratories (PELs) was organized on 28 May 2025 to introduce the new procedure for WHO’s performance evaluation of in vitro diag
Expanded reliance mechanisms
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PQT/MED currently has two major prequalification pathways – the full assessment pathway for generics not approved by a Stringent Regulatory A
Two additional MPXV tests listed by WHO under the Emergency Use Listing procedure
IVD
We are pleased to announce that two additional MPXV tests have been listed under WHO's Emergency use listin
The WHO Prequalification Unit is pleased to announce the opening of the ePQS portal to external users
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The WHO Prequalification (PQT) Unit is pleased to announce the opening of the ePQS portal to external users on 19 May 2025.
Join us for Informative webinar on the latest new WHO guidance on reportable changes to WHO PQ and EUL IVDs_19 May 2025
IVD
Dear colleagues,
You are invited to a Zoom webinar.
An additional HIV RDT was prequalified by WHO
IVD
The professional use only version of
WHO prequalified the first HIV-1 self-test by Urine
IVD
The WANTAI HIV SELF TEST BY URINE Rapid Urine Test for Detection of Antibody to Human Immunodeficiency Vir
Publication of updated Guidance and Application Form for Reportable changes to WHO prequalified and emergency use listed in vitro diagnostics
IVD
WHO is pleased to announce the publication of the revised guidan
Prequalification of IVDs scope expanded to haemoglobin PoC analysers
IVD
WHO is pleased to announce that the Prequalification of in vitro diagnostics programme has been expanded to point-of-care analysers intended for: