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News Archive
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.
FDA sets out investigator responsibilities for safety reporting in investigational drug and device studies
24th December 2025The FDA has published draft guidance clarifying what investigators must report, and when, during clinical research involving investigational drugs and devices.
MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare
24th December 2025The MHRA is asking the public, clinicians and industry to help shape future rules for AI in healthcare. Link to press release.
Processes and practices applicable to Bioresearch Monitoring (BIMO) inspections (FDA)
24th December 2025The FDA has issued final guidance setting out what sponsors and research sites should expect during BIMO inspections, and how to manage inspection communications and records requests.
Regulation of AI in healthcare – MHRA Call for Evidence
24th December 2025The MHRA is inviting views on how AI used in healthcare should be regulated, as part of work to shape a new UK framework for AI medical devices.
Sponsor responsibilities — safety reporting requirements and safety assessment for IND and BA/BE studies
24th December 2025The FDA has issued guidance setting out how sponsors should assess safety information and submit timely, meaningful safety reports during IND and bioavailability/bioequivalence studies.
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