News Archive

EMA - Clinical Trials Highlights Newsletter December 2025

11th December 2025

Out Now

Read More+

EMA post-authorisation procedural advice for users of the centralised procedure – tracked changes (updated December 2025)

11th December 2025

The European Medicines Agency (EMA) has released its updated post-authorisation procedural advice for centrally authorised medicines, with changes marked in the tracked-changes PDF to help Marketing Authorisation Holders (MAHs) see recent updates clearly.

Read More+

FDA issues warning letter to Apotex Inc for major CGMP violations

11th December 2025

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Canadian drugmaker Apotex Inc. after identifying significant quality and sterility failures at its Richmond Hill facility

Read More+

Strengthening collaboration between the MHRA and the Department of Health Northern Ireland

11th December 2025

The MHRA and Northern Ireland partners have agreed a new programme of collaboration to support innovation and patient safety.

Read More+

EMA Veterinary Newsletter

9th December 2025

December 2025

Read More+

GCP Regulatory News

9th December 2025

The GCP Committee have put together some news from the past quarter.

Read More+

CTIS Change Management Survey

4th December 2025

Extended deadline 16 January 2026

Read More+

Centres of Excellence for Regulatory Science and Innovation (CERSIs)

4th December 2025

The MHRA has launched a UK-wide network of Centres of Excellence to advance regulatory science and bring innovative treatments to patients sooner.

Read More+

Get regulatory advice from MHRA — Medical Devices

4th December 2025

MHRA offers formal “regulatory advice” to help device developers and manufacturers understand how UK medical-device regulations apply to their products.

Read More+

Landmark UK–US pharmaceuticals deal to safeguard medicines access and drive vital investment for UK patients and businesses

4th December 2025

The UK and US have struck a new trade agreement that removes tariffs on UK medicines exports to the US, aiming to boost investment and improve access to new treatments.

Read More+