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Immunization Devices Stream Menu

About Immunization Devices Prequalification
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WHO Catalogue of Prequalified Immunization Devices
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In Vitro Diagnostics Stream Menu

About In Vitro Diagnostic & Male Circumcision Device Prequalification
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Prequalified In Vitro Diagnostics
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Medicines Stream Menu

About Medicines Prequalification
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Pilot Prequalification of Biotherapeutic Products
Support to Manufacturers, CROs and QCLs
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eCTD

Vaccines Stream Menu

About Vaccines Prequalification
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eCTD

VCP Stream Menu

About Vector Control Products Prequalification
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Inspection Services Stream Menu

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WHO Public Assessment Reports (WHOPARs) published

News

22 July, 2025 - 09:03 (CEST)

Announcement

M

Latest News

17 - 19 September, 2025 - 13:00 - 18:00 (CEST)

AMA training

29 August, 2025 - 13:44 (CEST)

WHO launches a pilot parallel WHO Prequalification and TB policy assessment process for new TB IVDs

28 August, 2025 - 09:17 (CEST)

WHO Public Assessment Reports (WHOPARs) published

25 August, 2025 - 17:15 (CEST)

WHO Public Assessment Reports (WHOPARs) published

19 August, 2025 - 19:00 (CEST)

Announcement of the opening of the WHO e-Prequalification System (ePQS) for immunization device prequalification

Featured News

28 July, 2025

WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination goals

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

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