WHO Public Assessment Reports (WHOPARs) published
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News
Update on Nitrosamine Impurities
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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.
New EUL Listing: MPXV IVD
IVD
The PQT/AMD team has added a new product to the Emergency Use Listing (EUL):
WHO's Public Assessment Reports (WHOPARs) Updates
IVD
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
Two PQT Medicines workshops for manufacturers
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The PQT Medicines 8th Annual Medicines Quality Workshop for Manufacturers will take place from 27 to 30 October 2025.
EUL listing of an additional MPXV test
IVD
In a continuing effort to best support the MPXV response, the Prequalification Unit has listed the Monkeypox Virus
WHO has listed an additional TB test
IVD
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).
Additional HPV tests listing
IVD
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
Training for IVDs assessors for WHO Prequalification WHO Academy Lyon, 7-9 October 2025
IVD
A core component of the Prequalification assessment process relates to technical review of the product dossier and change requests.
First lenacapavirs prequalified
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Gilead’s Lenacapavir Tablet and Injection Products Prequalified by WHO
PQ IVDs Newsletter Q3 2025
IVD
We are pleased to announce that the PQ IVDs Newsletter Issue 50 - Q3 2025 has just been released today.
WHO Expands IVD Prequalification Scope to Support TB Diagnosis
IVD
TB and drug-resistant TB remain underdiagnosed globally.
WHO's announcement on PQ performance evaluations for HPV assays
IVD
WHO adopting the fulfilment of Meijer’s 2009 criteria in independent evaluations as WHO’s prequalification independent performance evaluation component for HPV nucleic acid tests.
Incepta’s medroxyprogesterone susp for injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Annual UN meeting with manufacturer and suppliers: Updates on IVDs
IVD
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
REGISTRATION OPEN - 2025 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers
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IVD
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VCP
On behalf of the United Nations Population Fund (UNFPA), the United Nations Children Fund (UNICEF) and the World Health Organization (WHO), we invite you to the 2025 UNFPA-UNICEF-WHO Annual Meeting
New EUL product listed for IVD
IVD
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
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
New EUL listing
IVD
An additional in vitro diagnostic has been listed under the Emergency Use Listing procedure.
Ajanta’s pyrimethamine/sulfadoxine +amodiaquine dispersible tablets prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Strides' cycloserine prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Dr Reddy’s rituximab now prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Lupin’s pretomanid tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
TB403 Pretomanid 200mg tablets - Lupin Limited - INDIA
Velvet-Med’s artemether/lumefantrine prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
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
Macleods’ miltefosine 50 mg capsule prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
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:
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: