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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
WHO statement on notification of withdrawal of the United States-of-withdrawal-of-the-united-states
26th January 2026Title: WHO statement on notification of withdrawal of the United States
EMA CVMP meeting highlights – 13–14 January 2026
21st January 2026The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) published key outcomes from its January 2026 meeting, including opinions on new veterinary medicines and updated guidance initiatives.
EMA PRAC meeting highlights — 12–15 January 2026
21st January 2026The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) met in mid-January 2026 to review emerging safety data and ongoing pharmacovigilance activities.
FDA draft guidance on Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
21st January 2026The U.S. Food and Drug Administration (FDA) has issued draft guidance to help sponsors apply Bayesian statistical methods more consistently in clinical trials supporting drug and biologics approvals.
FDA issues warning letter to Darmerica, LLC for significant CGMP and labelling violations
21st January 2026The U.S. Food and Drug Administration (FDA) on 8th December 2025 issued a warning letter to Darmerica, LLC following an inspection that identified major manufacturing and labelling deficiencies.
ICH E22 General Considerations for Patient Preference Studies (Step 2 Draft Guideline)
21st January 2026The International Council for Harmonisation (ICH) has released the Step 2 draft of the E22 guideline — General Considerations for Patient Preference Studies (PPS) — endorsed on 19 November 2025 and now open for public consultation.
ICH Expert Working Groups issue updated technical documents for three guidelines
21st January 2026The International Council for Harmonisation (ICH) has published new technical support documents for three key harmonised guidelines, helping stakeholders interpret and implement them.
M4Q(R2) — The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (FDA draft guidance)
21st January 2026The US Food and Drug Administration (FDA) has released the M4Q(R2) draft guidance outlining updated recommendations for how quality information should be structured in regulatory submissions.
EMA webpage dedicated to the reform of the EU pharmaceutical legislation
19th January 2026Following 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.
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.
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