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Immunization Devices Stream Menu

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Vaccines Stream Menu

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Inspection Services Stream Menu

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WHO Public Assessment Reports (WHOPARs) published

News

2 December, 2024 - 10:42 (CET)

Announcement

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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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