The much-anticipated guideline is now available for RQA members.
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More informationFollowing EMA's communication last month regarding the landmark political agreement between the European Parliament and the Council of the European Union on the reform of the EU pharmaceutical legislation, they are pleased to announce that an EMA webpage dedicated to the implementation of this new legislation has now been published.
The MHRA has published guidance explaining how UK clinical trial regulations align with the ethical principles of the Declaration of Helsinki.
The 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
The 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.
Professor Jacob George has started as MHRA’s first ever Chief Medical and Scientific Officer, bringing senior clinical and scientific leadership to the regulator.
The MHRA reflects on key med-tech achievements and regulatory milestones from 2025.
EDQM reflects on a year of major change — strengthening partnerships, modernising the European Pharmacopoeia and reaffirming its public-health mission.
EMA has launched a concept paper to modernise GMP Annex 3 for radiopharmaceuticals, reflecting major scientific and regulatory changes since 2008.
EMA’s Management Board welcomed political agreement on new EU pharma legislation and set out priorities and investment plans for 2026 and beyond.