- Home
-
Learn, develop, connect
*NEW* Global Guideline for GCP Audit
The much-anticipated guideline is now available for RQA members.
More information
8th Global QA Conference
Mind the gap - connected by quality. 4th - 6th November 2026, London.
More information -
Membership
Become part of RQA today
RQA membership is a great way to connect with your QA colleagues.
More information
RQA Community Hub
Join the community - networking, discussion and more. Open to all.
More information -
Knowledge Hub
Contribute to Quasar Magazine
Could you write an interesting article for the RQA community?
More information - About us
News Archive
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M4Q(R2) — The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (FDA draft guidance)
21st January 2026The US Food and Drug Administration (FDA) has released the M4Q(R2) draft guidance outlining updated recommendations for how quality information should be structured in regulatory submissions.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.
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.
- Home
- Learn, develop, connect
- Membership
- Knowledge Hub
- About us