News Archive

EMA - Transition to the Clinical Trials Information System (CTIS) by 31 January 2025

7th February 2024

All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.

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EMA - Veterinary medicines: Highlights of 2023

7th February 2024

On 24 January 2024 EMA published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.

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FDA - GMP for APIs Used in Veterinary Medicinal Products

7th February 2024

CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products Draft released and open for comments.

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FDA - Roundup, 6th February 2024

7th February 2024

An at-a-glance summary of news from around the agency

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MHRA - updates on to how to notify the MHRA of changes to the PV System

7th February 2024

Guidance updates on to how to notify the MHRA of changes to the PV System

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Union Health Ministry (India) notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945

7th February 2024

The revised Schedule M prescribes the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products; official says this will ensure Indian guidelines are at par with global standards.

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EMA - New Q&As on EU GMP Guide Annexe

2nd February 2024

Annex 1: Manufacture of sterile medicinal products

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MHRA - two new UK Approved Bodies to certify medical devices

2nd February 2024

MHRA announces two new UK Approved Bodies to certify medical devices

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EMA - Major update of the SME user guide

24th January 2024

The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.

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EMA - Highlights CVMP 16-17 Jan 2024

24th January 2024

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17 January 2024

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