First rifapentine product prequalified
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TB336: Rifapentine - 150mg - Film-coated tablets - Sanofi-Aventis U.S. LLC - USA
5th Invitation to Manufacturers of Medicinal Products for Treatment of Neglected Tropical Diseases
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The following products were added:
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Miltefosine 10mg and 50mg capsule
BTIF revised
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The revisions to the BTIF (Bioequivalence Trial Information Form) include the following changes to facilitate study assessment:
12th Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) for prequalification
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The following active pharmaceutical ingredients (APIs) were added:
- Benzathine benzylpen
11th Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs)
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The 11th invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API prequalification to the WHO Prequalification Team: medicines (PQTm
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
ID
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