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*NEW* Global Guideline for GCP Audit
The much-anticipated guideline is now available for RQA members.
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8th Global QA Conference
Mind the gap - connected by quality. 4th - 6th November 2026, London.
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RQA membership is a great way to connect with your QA colleagues.
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News Archive
Good clinical practice for clinical trials – updated December 2025
15th December 2025The 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.
UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies
15th December 2025The UK and Singapore have established a first-of-its-kind regulatory innovation corridor to help patients access cutting-edge health technologies more quickly.
EMA - Clinical Trials Highlights Newsletter December 2025
11th December 2025Out Now
EMA post-authorisation procedural advice for users of the centralised procedure – tracked changes (updated December 2025)
11th December 2025The 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.
FDA issues warning letter to Apotex Inc for major CGMP violations
11th December 2025The 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
Strengthening collaboration between the MHRA and the Department of Health Northern Ireland
11th December 2025The MHRA and Northern Ireland partners have agreed a new programme of collaboration to support innovation and patient safety.
EMA Veterinary Newsletter
9th December 2025December 2025
GCP Regulatory News
9th December 2025The GCP Committee have put together some news from the past quarter.
CTIS Change Management Survey
4th December 2025Extended deadline 16 January 2026
Centres of Excellence for Regulatory Science and Innovation (CERSIs)
4th December 2025The MHRA has launched a UK-wide network of Centres of Excellence to advance regulatory science and bring innovative treatments to patients sooner.
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