PQ IVDs Newsletter Q3 2025
IVD
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.
REGISTRATION OPEN - 2025 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers
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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
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
WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination goals
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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
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.
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.