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News Archive
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5th March 2026The FDA has published draft guidance based on the ICH E2D(R1) guideline, which updates international standards for managing and reporting post-approval safety data for medicines.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.
Small and Medium-sized Enterprises (SMEs) Highlights
5th March 2026The European Medicines Agency has published the latest issue of SMEs Highlights, a newsletter providing regulatory updates and information relevant to small and medium-sized enterprises involved in medicines development in the EU.
UK sets out world-leading pathway for space-manufactured drugs
5th March 2026UK sets out world-leading pathway for space-manufactured drugs
HRA guidance on changes to the clinical trials regulations
2nd March 2026The Health Research Authority has published guidance explaining the changes introduced by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which will take effect on 28 April 2026.
New pilot launched to get feedback on Information Governance guide
2nd March 2026The Health Research Authority (HRA) has launched a pilot to gather feedback on a new Information Governance (IG) guide for research.
Updates to Good clinical practice for clinical trials guidance – new CAPA guidance
2nd March 2026The MHRA has updated the Good Clinical Practice for clinical trials guidance to include new Corrective Action and Preventive Action (CAPA) support for inspection responses.
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