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Notice of Concern

On 19 August 2024, the revised 34th Invitation of APIs now includes baloxavir

News

22 August, 2024 - 00:12 (CEST)

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Related Documents

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38th Invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API evaluation to the WHO Prequalification Unit pdf

Latest News

30 June, 2025 - 09:52 (CEST)

Reportable changes to IVDs: Implementation of REACH Regulation

26 June, 2025 - 12:08 (CEST)

Submission of change requests for PQ-ed and EUL-listed IVDs

23 June, 2025 - 14:37 (CEST)

The third IVDs assessment session in 2025 successfully completed

23 June, 2025

WHO Immunization Devices prequalification announces the opening of the WHO e-prequalification system (ePQS) & Immunization Devices website

12 June, 2025 - 14:45 (CEST)

FAQs and Key Updates on the New Change Request Process for Prequalified and EUL IVDs

Featured News

11 June, 2025 - 11:00 (CEST)

First eCTD application for Active Pharmaceutical Ingredient (API) Prequalification received at WHO PQT via the ePQS Portal

10 June, 2025 - 10:00 (CEST)

First eCTD application received at WHO PQT via the ePQS Portal

14 May, 2025 - 09:00 (CEST)

The WHO Prequalification Unit is pleased to announce the opening of the ePQS portal to external users

5 May, 2025 - 09:00 (CEST)

WHO launches new learning catalogue to upskill regulatory workforce

31 March, 2025 - 09:00 (CEST)

Information on the GMP status of Mylan Laboratories Ltd (Viatris, Inc.) manufacturing facility situated at Indore, Pithampur (Madhya Pradesh, India)

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