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WHO PREQUALIFICATION
OF IN VITRO DIAGNOSTICS UPDATE
Issue 37 - Q1 2022
PREQUALIFIED IVDs
TrinScreen HIVproduct code : 5551100 Manufacturer : Trinity Biotech Manufacturing Ltd Date of prequalification : |
COVID-19 PANDEMIC AND EMERGENCY USE LISTING
Emergency Use Listing (EUL) for candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 remains ongoing.
WHO has expanded the scope of EUL to include SARS-CoV-2 AgRDTs intended for self-testing and invited manufacturers to contact WHO PQ as early as possible to discuss their EUL application.
CALL FOR PUBLIC COMMENTS: TECHNICAL SPECIFICATION SERIES (TSS)
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DRAFT - TSS 17 In vitro diagnostic (IVD) medical devices used for the qualitative detection of Mycobacterium tuberculosis complex (MTBC DNA) and mutations associated with drug-resistant tuberculosis (DR-TB). This is a draft, the content of this document is not final. For the full article, please click in the link below. |
TUBERCULOSIS (TB) IN VITRO DIAGNOSTICS (IVDs) COMING TO PQ
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The World Health Organization (WHO), through its Prequalification Unit and Global Tuberculosis Programme, announced future changes to the WHO procedure to determine procurement eligibility for tuberculosis (TB) in vitro diagnostics (IVDs). For the full article, please click in the link below. |
ANNUAL UN MEETING WITH MANUFACTURERS AND SUPPLIERS
The 2022 Joint UNICEF–UNFPA–WHO Meeting with Manufacturers and Suppliers of Contraceptive Devices, In Vitro Diagnostics, Vaccines and Immunization Devices, Finished Pharmaceutical Products, Active Pharmaceutical Ingredients and Vector Control Products was held virtually from 08 to 10 March 2022.
The agenda and presentations are available in the link below.
NEW PRIORITY CATEGORIZATION OF PQ AND EUL APPLICATIONS
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The prequalification team is committed to meeting the expectations and needs of Member States and UN procurement agencies. In order to manage the large For the full article, please click in the link below. |
In Vitro Diagnostics Assessment Team
Prequalification Unit
Regulation and Prequalification Department
Access to Medicines and Health Products Division
World Health Organization
