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MHRA Implementing the new UK Clinical Trials Regulations - Recording Available Now
26th March 2026Watch the MHRA webinar on Implementing the new UK Clinical Trials regulations, which took place on Thursday, 12 March 2026.
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Shaping the future of healthcare through global regulatory innovation
26th March 2026The MHRA highlights the importance of international collaboration to drive innovation in healthcare regulation.
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The new ILAP TDP: de-risking development through early insights and improved coordination
26th March 2026A new approach to the Innovative Licensing and Access Pathway aims to provide earlier guidance and greater predictability for developers.
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MHRA Chief Executive update to MHRA staff on clinical trial pathways
25th March 2026An update outlining MHRA’s progress and future direction for improving clinical trial pathways in the UK.
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New guidance published to improve patient information
19th March 2026UK guidance sets out how to make patient information clearer and more accessible.
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EMA Management Board highlights key outcomes from March 2026 meeting
18th March 2026The EMA Management Board has shared updates and key decisions from its March 2026 meeting.
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EMA introduces new PRIME tools to accelerate medicine development
18th March 2026The European Medicines Agency has launched new tools to support faster development of promising medicines.
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FDA releases draft guidance on alternatives to animal testing in drug development
18th March 2026The FDA has issued draft guidance promoting the use of non animal methods in drug development.
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HRA launches follow up survey to assess improvements in study set up at sites
18th March 2026The Health Research Authority is seeking feedback to measure progress in improving study set up across the UK.
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Patients to access new medicines up to six months earlier under MHRA and NICE collaboration
18th March 2026A new joint approval process aims to speed up patient access to innovative medicines in the UK.
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New EMA Industry Highlights Quarterly Newsletter
17th March 2026The European Medicines Agency (EMA) Industry Highlights is a new quarterly newsletter for industry stakeholders providing updates on the latest regulatory and policy developments, with a focus on topics that directly impact industry and may require action.
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EMA issues new guidance on conducting clinical trials during public health emergencies in the EU
12th March 2026The European Medicines Agency has released new guidance to support clinical trials during public health emergencies.
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FDA launches new Adverse Event Look-up Tool
12th March 2026The US Food and Drug Administration has introduced a new tool to improve access to adverse event data.
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FDA publishes CDER Guidance Agenda outlining planned drug guidance documents
12th March 2026The US Food and Drug Administration has published its latest CDER Guidance Agenda setting out potential guidance documents for drug regulation.
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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.
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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.
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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.
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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.
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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.
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Human Medicines Highlights March 2026
6th March 2026The newsletter for patients, consumers and healthcare professionals
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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.
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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.
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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.
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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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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.
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UK sets out world-leading pathway for space-manufactured drugs
5th March 2026UK sets out world-leading pathway for space-manufactured drugs
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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.
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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.
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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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Strengthening supply chain cyber security at the MHRA
27th February 2026The MHRA has published its new approach to bolstering cyber security across its supply chains to better protect regulated products and services.
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EMA Human Medicines Highlights – February 2026
26th February 2026The European Medicines Agency’s Human Medicines Highlights newsletter provides key regulatory updates for medicines in the EU.
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Regulation as an enabler of innovation — a regional perspective
26th February 2026The MHRA shares insights on how regulatory frameworks can drive innovation and economic growth across UK regions.
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Get integrated scientific advice from the MHRA and NICE for medicines
23rd February 2026The MHRA and NICE now offer a joined-up scientific advice service to help medicine developers align regulatory and health technology assessment evidence needs early in development.
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UK medical device testing hits record high as MHRA backs growth in brain and AI technology
19th February 2026UK medical device testing hits record high as MHRA backs growth in brain and AI technology
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Concept paper on revision of the guidelines on good manufacturing practice for medicinal products - annex 6 manufacture of medicinal gases
18th February 2026Consultation open: 11/02/2026 to 11/04/2026
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Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation
18th February 2026Consultation dates: 09/02/2026 to 09/04/2026
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EMA CVMP Meeting Highlights — 10–12 February 2026
18th February 2026he European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) published outcomes from its February 2026 plenary meeting, covering new product opinions, variations, pharmacovigilance updates and draft guidance.
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EMA PRAC Meeting Highlights — 9–12 February 2026
18th February 2026The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a major safety review and issued key risk-management recommendations for human medicines.
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Global commitment on display as countries negotiate key annex to the Pandemic Agreement
18th February 2026WHO Member States have shown strong unity in advancing negotiations on a critical annex to the global Pandemic Agreement aimed at improving pandemic preparedness and equity.
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Medical Devices Regulations – Targeted Consultation on the Indefinite Recognition of CE-Marked Devices
18th February 2026The MHRA is consulting on proposals to allow CE-marked medical devices to be recognised indefinitely in Great Britain.
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Mock example developed to illustrate quality modules of ICH M4Q (R2) Common Technical Document
18th February 2026The International Council for Harmonisation (ICH) has published a mock example to help stakeholders understand the revised quality modules in the updated CTD guideline.
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Timelines for acceptance of CE-marked medical devices in Great Britain (GB)
18th February 2026MHRA has published expected timelines for when CE-marked medical devices and IVDs can continue to be accepted in Great Britain.
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Updates to Clinical Trials Regulations — Transitional Arrangements Guidance
18th February 2026The MHRA has updated its clinical trials transitional guidance to clarify timelines and labelling requirements under the new UK clinical trial regime.
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Chemical Safety and Biosafety Progress Report
11th February 2026February 2026 (OECD)
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Impact of the amended CIR 520/2012 to UK-authorised products Blog
11th February 2026The MHRA Inspectorate explains how recent changes to the EU’s pharmacovigilance implementing regulation (CIR 520/2012) affect UK-authorised medicines and how companies should respond.
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FDA guidance on Computer Software Assurance for production and quality management system software
10th February 2026The FDA has published final guidance explaining how manufacturers can use a risk-based approach to assure software used in production and quality systems.
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Updates to CIR 520/2012 – information for UK Marketing Authorisation Holders
10th February 2026The MHRA has published guidance clarifying how amendments to Commission Implementing Regulation (CIR) 520/2012 affect UK-authorised medicines from 12 February 2026.
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Mila to Millions: A New Era of Individualized Medicines
3rd February 2026MHRA publishes a powerful guest blog by Julia Vitarello on why the UK must lead the way in personalised medicines that treat people with rare genetic diseases.
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EMA Guidelines on Veterinary Medicine - open for consultation
30th January 2026EMA has published four documents relating to veterinary medicine for public consultation.
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MHRA Newsletter January 2026
30th January 2026The MHRA’s industry newsletter highlights key regulatory news and updates as the year begins.
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Clinical Trials Highlights - January 2026
29th January 2026Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
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EMA webinar on the use of platform technologies in the non-clinical and clinical domains
29th January 2026The EMA are pleased to inform you that a webinar on the use of platform technologies in the non-clinical and clinical domains will be held on 2 March 2026 from 09:25 to 12:15 CET.
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FDA Clinical Decision Support Software – Final Guidance
29th January 2026The FDA’s Clinical Decision Support Software guidance explains the agency’s regulatory approach for CDS tools used in healthcare.
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Veterinary Medicines Highlights - January 2026
29th January 2026Quarterly news, activities and interviews from EMA Veterinary Medicines Division
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MHRA takes over chair of the International Access Consortium for 2026
27th January 2026The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has begun its 2026 term as Chair of the Access Consortium, strengthening global regulatory collaboration to improve patient access to new medicines.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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EMA Human Medicines Highlights - December 2025
18th December 2025Read online now
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Health Institution Exemption for General Medical Devices
18th December 2025The MHRA has published updated guidance explaining how the Health Institution Exemption (HIE) works for general medical devices used in UK health and care settings.
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MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices
18th December 2025New MHRA guidance helps health institutions safely make or adapt general medical devices for their own patients in Great Britain.
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EMA welcomes political agreement on new EU pharmaceutical legislation
15th December 2025The European Medicines Agency (EMA) has welcomed a landmark political agreement to reform the EU’s pharmaceutical legislation — the biggest overhaul in more than two decades.
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Good clinical practice for clinical trials – updated December 2025
15th December 2025The MHRA’s Good Clinical Practice (GCP) guidance for clinical trials in the UK was refreshed on 12 December 2025, clarifying expectations for compliance and inspections.
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UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies
15th December 2025The UK and Singapore have established a first-of-its-kind regulatory innovation corridor to help patients access cutting-edge health technologies more quickly.
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EMA - Clinical Trials Highlights Newsletter December 2025
11th December 2025Out Now
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EMA post-authorisation procedural advice for users of the centralised procedure – tracked changes (updated December 2025)
11th December 2025The European Medicines Agency (EMA) has released its updated post-authorisation procedural advice for centrally authorised medicines, with changes marked in the tracked-changes PDF to help Marketing Authorisation Holders (MAHs) see recent updates clearly.
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FDA issues warning letter to Apotex Inc for major CGMP violations
11th December 2025The U.S. Food and Drug Administration (FDA) has issued a warning letter to Canadian drugmaker Apotex Inc. after identifying significant quality and sterility failures at its Richmond Hill facility
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Strengthening collaboration between the MHRA and the Department of Health Northern Ireland
11th December 2025The MHRA and Northern Ireland partners have agreed a new programme of collaboration to support innovation and patient safety.
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EMA Veterinary Newsletter
9th December 2025December 2025
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GCP Regulatory News
9th December 2025The GCP Committee have put together some news from the past quarter.
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CTIS Change Management Survey
4th December 2025Extended deadline 16 January 2026
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Centres of Excellence for Regulatory Science and Innovation (CERSIs)
4th December 2025The MHRA has launched a UK-wide network of Centres of Excellence to advance regulatory science and bring innovative treatments to patients sooner.
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Get regulatory advice from MHRA — Medical Devices
4th December 2025MHRA offers formal “regulatory advice” to help device developers and manufacturers understand how UK medical-device regulations apply to their products.
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Landmark UK–US pharmaceuticals deal to safeguard medicines access and drive vital investment for UK patients and businesses
4th December 2025The UK and US have struck a new trade agreement that removes tariffs on UK medicines exports to the US, aiming to boost investment and improve access to new treatments.
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EDQM issues draft revised guideline on revision/renewal of CEPs for public consultation
2nd December 2025The EDQM has released a draft update to its guideline on revising and renewing Certificates of Suitability (CEPs) to the European Pharmacopoeia (Ph. Eur.) — and is now inviting public consultation.
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EMA Human Medicines Highlights
2nd December 2025November 2025 Edition out now
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FDA Drafts Guidance on Where to Submit Cross-Center Master Files
2nd December 2025The U.S. Food and Drug Administration (FDA) has issued draft recommendations clarifying which centre should host “cross-centre” Master Files (MFs) when they support multiple product types.
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FDA Issues New Guidance on CGMP for Medical Gases
2nd December 2025The Food and Drug Administration (FDA) has published a draft guidance to support the implementation of updated manufacturing rules for medical gases.
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FDA expands artificial-intelligence capabilities with “agentic” AI deployment
2nd December 2025The U.S. Food and Drug Administration (FDA) has rolled out “agentic AI” to support staff across the agency — marking a major step in its internal AI rollout.
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ICH Assembly Meeting, Singapore — November 2025
2nd December 2025The International Council for Harmonisation (ICH) held its 2025 Assembly in Singapore, completing major guideline decisions and welcoming new members.
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International Council for Harmonisation (ICH) Assembly Welcomes New Members and Observers
2nd December 2025ICH expands its global regulatory network by admitting new members and observers during its November 2025 meeting.
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Meeting Highlights – European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 24–27 November 2025
2nd December 2025The EMA’s PRAC met 24–27 November to review safety-related issues for authorised medicines — concluding no new referral procedures, but continuing ongoing assessments and routine pharmacovigilance tasks.
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New MHRA-supported research reveals patterns of vaccine-derived poliovirus spread
2nd December 2025A major study offers new insight into how vaccine-derived poliovirus type 2 spreads and what this means for global eradication.
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Innovative approaches to Med Tech regulatory reform
28th November 2025The MHRA sets out new steps to modernise the UK’s medical technology regulatory framework.
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Insurance Review in Phase 1 Clinical Trials
28th November 2025The MHRA Inspectorate clarifies updated insurance requirements for Phase 1 clinical trials ahead of the 2026 regulations.
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MHRA Strategy Blog Series
20th November 2025The MHRA has launched a strategy blog series bringing together external voices to discuss the future direction of UK medicines and medical devices regulation.
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Professor Alastair Denniston: The future regulation of AI in healthcare
20th November 2025Professor Alastair Denniston sets out core principles for a new UK framework to regulate AI in healthcare so it is safe, fast and trusted.
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EMA CHMP Meeting Highlights – 10-13 November 2025
19th November 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten new medicines for approval and four extensions of indication at its November 2025 session.
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EMA Improves Scientific Advice for Medicines Addressing Public Health Threats —including Antimicrobial Resistance
19th November 2025The European Medicines Agency (EMA) has enhanced its scientific advice services to better support the development of medicines tackling public-health threats like antimicrobial resistance.
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Multi-million-pound backing for cutting-edge projects by UK scientists and innovators
19th November 2025The UK government has announced substantial funding to accelerate scientific breakthroughs and innovation across key sectors.
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Quality Management System Information for Certain Premarket Submission Reviews
19th November 2025The Food and Drug Administration (FDA) has issued draft guidance outlining new expectations for Quality Management System (QMS) documentation in device pre-market submissions.
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The Importance of Accurate GTIN and 2D Barcode Data in the Modern Healthcare Environment
19th November 2025A new blog post by the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate highlights how precise Global Trade Item Number (GTIN) and 2D barcode information are critical to patient safety and supply-chain integrity.
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EMA partners with healthcare professionals & consumers for #ItTakesATeam medicine shortages campaign
13th November 2025The European Medicines Agency (EMA) has launched the #ItTakesATeam awareness campaign to emphasise that tackling medicine shortages in the EU requires collaboration among patients, professionals, and regulators
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MHRA-led study finds major inconsistencies in global microbiome research
13th November 2025New international benchmarks aim to make gut microbiome studies more reliable for diagnosis and treatment.
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100 Years of Protecting Patients Through Biological Standards for Medicines
15th October 2025On World Standards Day, 14th October 2025, the MHRA commemorates a century of ensuring the safety, efficacy, and consistency of medicines and vaccines through biological standards.
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Dr Nicola Rose: A New Antibiotic Is Positive News – But It Will Take More to Stay Ahead of Superbugs
15th October 2025The MHRA's Interim Executive Director of Science and Research discusses the approval of gepotidacin, the UK's first new antibiotic for urinary tract infections in nearly 30 years, and the broader challenge of combating antibiotic resistance.
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Veterinary Medicines Highlights – Issue 22
14th October 2025The European Medicines Agency (EMA) has released the 22nd edition of its quarterly newsletter, providing updates on veterinary medicines regulation as of October 2025.
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A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors
10th October 2025The MHRA explores the unique challenges of supplying medicines to remote locations via air and sea, emphasising compliance with Good Distribution Practice (GDP).
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EMA Management Board Highlights: October 2025
10th October 2025The European Medicines Agency (EMA) Management Board convened on 2nd October 2025, reviewing mid-year performance and endorsing strategic initiatives.
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EMA Seeks Public Input on Enhancing Patient Perspectives in Medicine Regulation
10th October 2025The European Medicines Agency (EMA) has released a draft reflection paper inviting public consultation on integrating patient experience data into the regulatory process.
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EMA's PRAC Meeting Highlights: 29th September – 2nd October 2025
10th October 2025The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) convened from 29th September to 2nd October 2025, addressing various aspects of medicine safety.
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FDA Issues Final Guidance on Assessing Drug Manufacturing Facilities Using Alternative Tools
10th October 2025The FDA has finalised guidance on employing alternative tools to evaluate drug manufacturing facilities in pending applications.
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MHRA Patient Safety Essay Competition 2025
10th October 2025The MHRA invites medical students and foundation doctors to explore how genetics can enhance prescribing safety and patient outcomes in the UK.
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MHRA Updates Guidance on Clinical Trials Involving In Vitro Diagnostic Devices
10th October 2025The MHRA has released updated guidance for conducting clinical trials that include in vitro diagnostic (IVD) devices.
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MHRA Updates Guidance on Clinical Trials Requiring Expert Advice
10th October 2025The MHRA has released updated guidance for clinical trials that necessitate expert advice from specialist groups or committees.
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MHRA Updates Guidance on Clinical Trials: Collection, Verification, and Reporting of Safety Events
10th October 2025The MHRA has released an updated version of its guidance on safety event management in clinical trials.
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MHRA Updates Guidance on Ending Clinical Trials
10th October 2025The MHRA has released updated guidance on the process for ending clinical trials, effective from 28th April 2026.
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MHRA Updates Guidance on Modifying Clinical Trial Approvals: Introduction of Route A and B Processes
10th October 2025The MHRA has updated its guidance on modifying clinical trial approvals, introducing Route A and B processes to streamline amendments.
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MHRA Updates Guidance on Non-Investigational Medicinal Products in Clinical Trials
10th October 2025The MHRA has released updated guidance on the use of non-investigational medicinal products (NIMPs) in clinical trials, effective from 28th April 2026.
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MHRA Updates Labelling Requirements for Investigational Medicinal Products (IMPs) in Clinical Trials
10th October 2025The MHRA has released updated guidance on labelling requirements for IMPs used in clinical trials, effective from 1st October 2025.
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MHRA and US FDA Forge New Collaboration on Medical Technologies and AI
10th October 2025The UK and US regulators have strengthened their partnership to accelerate innovation, enhance patient safety, and reduce market access barriers for medical technologies and AI-driven healthcare solutions.
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UK Clinical Trial Approval Times Halved with AI and Regulatory Reforms
10th October 2025The UK has reduced clinical trial approval times from 91 to 41 days, enhancing patient access to new treatments.
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WHO Launches Global Clinical Trials Forum to Strengthen Research Infrastructure
10th October 2025On 7th October 2025, the World Health Organization (WHO) officially launched the Global Clinical Trials Forum (GCTF), a collaborative network aimed at enhancing clinical trial environments and infrastructure globally.
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