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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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News Archive
Declaration of Helsinki and clinical trial regulations – alignment
13th January 2026The MHRA has published guidance explaining how UK clinical trial regulations align with the ethical principles of the Declaration of Helsinki.
ICH E6(R3) annotations — UK guidance published
13th January 2026The MHRA has published annotated ICH E6(R3) guidance to help sponsors interpret and apply the updated Good Clinical Practice standard in the UK.
Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation
13th January 2026Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation
Professor Sir Aziz Sheikh: Towards next-generation pharmacovigilance capabilities for the UK
12th January 2026The MHRA’s latest strategy blog — written by Professor Sir Aziz Sheikh — sets out ideas for transforming how the UK monitors medicine and medical product safety using real-world data and digital systems.
MHRA welcomes Professor Jacob George as he starts Chief Medical and Scientific Officer role
6th January 2026Professor Jacob George has started as MHRA’s first ever Chief Medical and Scientific Officer, bringing senior clinical and scientific leadership to the regulator.
2025 in MedTech: a year of innovation, global leadership and regulatory milestones
24th December 2025The MHRA reflects on key med-tech achievements and regulatory milestones from 2025.
2025 – A year of collaboration, new beginnings and long-standing commitments (EDQM)
24th December 2025EDQM reflects on a year of major change — strengthening partnerships, modernising the European Pharmacopoeia and reaffirming its public-health mission.
Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
24th December 2025EMA has launched a concept paper to modernise GMP Annex 3 for radiopharmaceuticals, reflecting major scientific and regulatory changes since 2008.
EMA Management Board: highlights of December 2025 meeting
24th December 2025EMA’s Management Board welcomed political agreement on new EU pharma legislation and set out priorities and investment plans for 2026 and beyond.
FDA guidance on using Real-World Evidence (RWE) for medical device regulatory decisions
24th December 2025The FDA has updated guidance on how Real-World Evidence can support medical device approvals and post-market decisions.
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