News Archive

Sponsor responsibilities — safety reporting requirements and safety assessment for IND and BA/BE studies

24th December 2025

The FDA has issued guidance setting out how sponsors should assess safety information and submit timely, meaningful safety reports during IND and bioavailability/bioequivalence studies.

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EMA Human Medicines Highlights - December 2025

18th December 2025

Read online now

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Health Institution Exemption for General Medical Devices

18th December 2025

The MHRA has published updated guidance explaining how the Health Institution Exemption (HIE) works for general medical devices used in UK health and care settings.

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MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices

18th December 2025

New MHRA guidance helps health institutions safely make or adapt general medical devices for their own patients in Great Britain.

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EMA welcomes political agreement on new EU pharmaceutical legislation

15th December 2025

The European Medicines Agency (EMA) has welcomed a landmark political agreement to reform the EU’s pharmaceutical legislation — the biggest overhaul in more than two decades.

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Good clinical practice for clinical trials – updated December 2025

15th December 2025

The MHRA’s Good Clinical Practice (GCP) guidance for clinical trials in the UK was refreshed on 12 December 2025, clarifying expectations for compliance and inspections.

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UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies

15th December 2025

The UK and Singapore have established a first-of-its-kind regulatory innovation corridor to help patients access cutting-edge health technologies more quickly.

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EMA - Clinical Trials Highlights Newsletter December 2025

11th December 2025

Out Now

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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.

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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

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