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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
MHRA News: £14bn opportunity identified through medicine reclassification
12th March 2026New analysis highlights the economic and healthcare benefits of expanding access to medicines through reclassification.
Singapore reaches WHO’s highest classification for medical device regulation
12th March 2026Singapore has become the first country to achieve the World Health Organization’s highest classification for medical device regulatory systems.
Global impact of UK health data resource highlighted in newly published paper
11th March 2026A new paper highlights the worldwide research impact of a major UK health data resource.
IMDRF launches consultation on clinical evidence for IVD medical devices
11th March 2026The International Medical Device Regulators Forum has opened a public consultation on new guidance for clinical evidence and performance evaluation of IVD medical devices.
MHRA publishes guidance on GMP and radiopharmaceutical investigational medicines in clinical trials
11th March 2026New UK guidance explains manufacturing and regulatory expectations for investigational medicines used in clinical trials.
Human Medicines Highlights March 2026
6th March 2026The newsletter for patients, consumers and healthcare professionals
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
5th March 2026The FDA has published draft guidance based on the ICH E2D(R1) guideline, which updates international standards for managing and reporting post-approval safety data for medicines.
Joint statement from the UK Space Agency, MHRA, the Regulatory Innovation Office and the Civil Aviation Authority
5th March 2026The UK Space Agency, MHRA, the Regulatory Innovation Office and the Civil Aviation Authority have issued a joint statement outlining how they will support the development of pharmaceuticals manufactured in space.
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers
5th March 2026The FDA has issued guidance explaining how the agency interprets and applies the three-year exclusivity provision for drug products that rely on new clinical investigations.
OECD Training Material on Test Item
5th March 2026This presentation has been prepared and agreed by the members of the OECD GLP Working Party. This presentation has been prepared and agreed by the members of the OECD GLP Working Party composed of representatives of all GLP Compliance Monitoring Authorities of the countries adherent to MAD (Mutual Acceptance of Data). This training material can be used to remind study personnel, especially the study directors, the requirements about test item as stated in the GLP Principles and clarified in OECD Document No. 19. The responsibility for GLP implementation remains with the sponsor/test facility.
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