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Notice of Concern

New WHO Public Assessment Reports (WHOPARs) published

News

12 December, 2017 - 04:00 (CET)

Announcement

M

Related Documents

M

TB315

Moxifloxacin (hydrochloride)

400mg - Film-coated tablets

Hetero Labs Ltd

India

Latest News

12 June, 2025 - 14:45 (CEST)

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

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

9 - 13 June, 2025 - 15:00 - 18:00 (CEST)

Two PQT Medicines trainings for regulators

9 June, 2025 - 00:12 (CEST)

Active Pharmaceutical Ingredient (API) Prequalified

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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