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FDA warns Safrel Pharmaceuticals over significant CGMP violations
11th September 2026FDA has issued a Warning Letter to Safrel Pharmaceuticals following an inspection that identified significant weaknesses in its quality systems and oversight of contract manufacturers.
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Independent Commission sets out blueprint for safe AI adoption in healthcare
11th September 2026New recommendations aim to help the NHS adopt AI more quickly while maintaining patient safety, transparency and public trust.
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MHRA and Manchester NHS launch health innovation sandbox
11th September 2026A new partnership will test emerging healthcare technologies, including AI, in real NHS settings to support safer and faster adoption.
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National Commission sets out recommendations for future AI regulation in healthcare
11th September 2026A new report proposes a more proportionate, lifecycle-based and system-wide approach to regulating AI in UK healthcare.
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MHRA regulatory reform amendments tabled in Government’s Health Bill
2nd September 2026Proposed amendments aim to modernise UK medicines and medical device regulation, including information sharing, more adaptable legislation and potential future MHRA licensing of medical devices.
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Turning possibility into progress: health innovation in Wales
2nd September 2026Wales’ connected health and life sciences ecosystem could provide an agile environment for developing, evaluating and adopting healthcare innovation.
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European study identifies regulatory research priorities for AI in medicines
18th August 2026New research highlights the key regulatory science priorities needed to support trustworthy AI use across the medicines lifecycle.
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Human Medicines Highlights: August 2026
5th August 2026EMA's latest Human Medicines Highlights features new medicine recommendations, faster regulatory pathways and updates on innovation across human medicines.
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HRA Latest: July 2026 updates on research approvals, guidance and study set-up
31st July 2026The HRA's latest newsletter highlights faster clinical trial approvals, new research guidance and improvements to study set-up across the UK.
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London Region I MHRA Regulatory Sandbox: call for expressions of interest
31st July 2026MHRA has opened expressions of interest for organisations wishing to take part in its London Region I regulatory sandbox, supporting the safe evaluation of AI-enabled medical devices in NHS settings.
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MHRA News: July 2026 highlights innovation, AI and regulatory developments
31st July 2026The latest MHRA newsletter highlights regulatory innovation, AI guidance, clinical trials improvements and international collaboration.
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Clinical Trials Highlights: July 2026
29th July 2026The latest Clinical Trials Highlights newsletter focuses on improving transparency in clinical research, key CTIS developments and upcoming changes affecting clinical trial sponsors.
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EMA consults on guidance for RNA-based veterinary therapies
29th July 2026The EMA has opened a public consultation on a new guideline covering the quality and safety of RNA interference and RNA antisense oligonucleotide therapies for veterinary medicines.
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EMA consults on revision of veterinary fixed combination products guideline
29th July 2026The EMA has launched a public consultation on plans to revise its guideline for pharmaceutical fixed combination veterinary medicinal products.
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European Commission updates Q&A on safety features for human medicines
29th July 2026The European Commission has published Version 22 of its Questions and Answers document on the safety features required for medicinal products for human use.
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WHO - Draft Guidelines on GCP
29th July 2026The WHO has recently published a draft guideline, including two annexes, on Good Clinical Practice (GCP) for clinical trials involving medicinal products. Comments on these documents may be submitted until 6 September 2026 (which can be done on the PleaseReviewTM online platform).
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New UK-Swiss workshop explores scaling pharmaceutical research in space
23rd July 2026The UK and Switzerland have launched a new collaboration to explore how microgravity research and in-orbit pharmaceutical manufacturing can be scaled from scientific promise to commercial reality.
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Concept paper on the revision of EU-PIC/S GMP Annex 15 (Qualification and validation) - Corrigendum
22nd July 2026EMA and PIC/S have published a corrigendum to the concept paper on revising GMP Annex 15, with an updated timetable following public consultation.
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MHRA delivers record performance as 2025 to 2026 Annual Report and Accounts confirms growing global influence
22nd July 2026The MHRA's latest Annual Report highlights record performance, faster regulatory delivery and growing international influence while supporting innovation across medicines and healthcare.
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Public consultation for reflection paper on particulars for safety signals for (traditional) herbal medicinal products
22nd July 2026The European Medicines Agency has published for public consultation a draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products.
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MHRA safety review gives UK plasma donations go ahead
10th July 2026MHRA has concluded that UK-donated plasma can be safely used to manufacture five additional plasma-derived medicines, supporting a more resilient domestic supply of vital treatments.
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Veterinary Medicines Highlights – Summer 2026
10th July 2026EMA's latest Veterinary Medicines Highlights newsletter includes regulatory updates, new guidance, IT system enhancements and upcoming opportunities for stakeholder engagement.
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Four sentenced to nearly 15 years combined jail time following major MHRA investigation into illegal online supply of medicines
9th July 2026Four members of an organised criminal group have been sentenced following an MHRA investigation into the large-scale illegal online supply of medicines across the UK.
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Medicines and Healthcare products Regulatory Agency (MHRA) Economic Growth Goals
9th July 2026The MHRA has published its Economic Growth Goals, outlining how regulation will support innovation, investment and patient access to medicines and medical technologies across the UK.
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Clinical Trials Highlights issue 34 - June 2026
2nd July 2026EMA's latest Clinical Trials Highlights provides updates on ACT EU, CTIS developments, sponsor responsibilities and new initiatives to improve the efficiency and transparency of clinical trials across Europe.
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MHRA updates best practice guidance on patient information leaflets
2nd July 2026The MHRA has updated its guidance to reflect the UK's post-EU regulatory framework while reinforcing best practice for developing clear, accessible patient information leaflets.
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MHRA updates guidance on warning statements for medicine labels and leaflets
2nd July 2026The MHRA has updated its guidance on the warning statements that should appear on the labels and patient information leaflets of certain medicines.
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CHMP meeting highlights: 22 to 25 June 2026
1st July 2026The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended several new medicines for approval and adopted key opinions on the safety and use of medicines at its June 2026 meeting.
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CVMP meeting highlights: 16 to 18 June 2026
1st July 2026The EMA's Committee for Veterinary Medicinal Products (CVMP) has adopted recommendations on veterinary medicines and discussed key regulatory developments at its June 2026 meeting.
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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
1st July 2026The FDA has published final guidance outlining its current recommendations for demonstrating substantial evidence of effectiveness for human drugs and biological products.
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Digital mental health technology
1st July 2026The MHRA's digital mental health technology collection brings together guidance, research and resources to support the safe regulation and evaluation of digital mental health technologies.
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MHRA News: June 2026
1st July 2026The latest MHRA newsletter highlights recent regulatory developments, approvals, guidance and safety updates from across the medicines and medical devices sector.
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MHRA Safety Roundup: June 2026
1st July 2026The MHRA's June 2026 Safety Roundup highlights the latest medicines and medical device safety updates, recalls and regulatory advice for healthcare professionals and patients.
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Master Protocols for Drug and Biological Product Development
1st July 2026The FDA has published final guidance on the use of master protocols to support more efficient and flexible drug and biological product development.
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PRAC meeting highlights: 8 to 11 June 2026
1st July 2026The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has published the key safety recommendations and regulatory outcomes from its June 2026 meeting.
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The ILAP and the Aligned Pathway: What's the difference?
1st July 2026An MHRA blog explains the differences between the Innovative Licensing and Access Pathway (ILAP) and the Aligned Pathway, helping innovators choose the most appropriate route for developing and bringing medicines to patients.
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The next frontier: Unlocking in-orbit manufacturing of medicines
1st July 2026An MHRA blog explores how manufacturing medicines in space could transform pharmaceutical development and highlights the UK's role in supporting this emerging field.
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MHRA launches Innovation Accelerator for innovative products
30th June 2026The new service brings MHRA innovation support into a single route for developers seeking regulatory advice.
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MHRA sets standards for AI use in GxP inspection responses
30th June 2026The MHRA has clarified how AI can be used for inspection submissions without replacing human accountability.
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UK sets out pathway for medicines manufactured in orbit
26th June 2026The MHRA and UK Space Agency are developing regulatory support for medicines made in microgravity.
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Update on the PATHWAYS Clinical Trial
22nd June 2026MHRA has confirmed that a modified protocol for the PATHWAYS clinical trial has met regulatory standards, allowing the study to proceed with strengthened participant safeguards.
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EMA Annual Report 2025
19th June 2026European Medicines Agency’s annual report for 2025, highlighting progress in bringing innovative, safe and effective medicines to patients.
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EMA SME Highlights Issue 69: New Support for Innovation, AI and Clinical Developm
19th June 2026EMA’s June 2026 SME newsletter outlines new initiatives, regulatory support tools and upcoming opportunities for small and medium-sized enterprises developing medicines and medical devices.
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MHRA and FDA Launch Unique Liaison Programme to Strengthen Regulatory Collaboration
16th June 2026The MHRA and US FDA have established a new liaison programme to deepen cooperation and support innovation in medicines and medical devices regulation.
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MHRA Launches AI Sandbox to Accelerate Medicines Development and Improve Safety
11th June 2026A new MHRA AI Sandbox programme will provide a controlled environment for testing artificial intelligence tools used in medicines development and regulation.
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National AI Commission "Ask Me Anything" Highlights Public Priorities for AI in Healthcare
11th June 2026MHRA's public webinar explored how AI should be regulated in healthcare, with patient safety, transparency and accountability emerging as key concerns.
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Advancing AI Regulation in Healthcare: Insights from AI Airlock Phase 2
9th June 2026MHRA shares early lessons from the second phase of its AI Airlock programme, helping shape the future regulation of AI-powered medical devices in healthcare.
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Advancing AI Regulation in Healthcare: Insights from AI Airlock Phase 2
9th June 2026MHRA shares early lessons from the second phase of its AI Airlock programme, helping shape the future regulation of AI-powered medical devices in healthcare.
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ICH E6(R3) Annex 2 Finalised at Step 4, Expanding GCP Guidance for Modern Clinical Trials
5th June 2026ICH has adopted the final Step 4 version of E6(R3) Annex 2, providing additional Good Clinical Practice guidance for decentralised, pragmatic and real-world data-enabled clinical trials.
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MHRA publishes 2026 performance data to improve transparency
25th May 2026New data release highlights how the MHRA is performing across key regulatory activities.
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Oxford scientists race to develop Ebola vaccine for rare outbreak
22nd May 2026A new Ebola vaccine could enter clinical trials within months as cases rise in DR Congo.
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Landmark plans bring rare disease treatments a step closer
21st May 2026New UK plans aim to speed up access to innovative therapies for rare disease patients.
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MHRA and NICE launch real world evidence scientific dialogue
21st May 2026New joint initiative aims to strengthen the use of real world evidence in decision making.
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MHRA consults on new framework to boost rare disease therapies
21st May 2026Proposals aim to position the UK as a global leader in developing treatments for rare diseases.
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MHRA to support life sciences growth in Wales
20th May 2026New MHRA initiative aims to strengthen the life sciences sector across Wales.
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ICH M11 Expert Working Group publishes final overview presentation
18th May 2026Final materials released to support implementation of the ICH M11 guideline on clinical study protocols.
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PRAC highlights from May 2026 meeting
18th May 2026Key safety updates and regulatory recommendations from EMA’s Pharmacovigilance Risk Assessment Committee.
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Professor Joann Rhodes calls for flexible regulation to unlock life sciences potential
18th May 2026A call for more adaptable policies and stronger collaboration to accelerate innovation in life sciences.
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VMD launches new online contact form
18th May 2026A new digital contact form aims to improve how stakeholders engage with the Veterinary Medicines Directorate.
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WHO launches online course to strengthen good clinical trial practices
18th May 2026A new WHO course aims to improve global standards in the conduct of clinical trials.
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Consultation on the regulation of gene therapy medicinal products
15th May 2026The UK government is seeking views on how gene therapy medicines should be regulated in the future.
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MHRA invites views on proposed changes to medical device regulation
15th May 2026The MHRA is consulting on reforms to strengthen the regulation of medical devices in the UK.
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MHRA supports Northern Ireland life sciences sector with new hub
14th May 2026A new MHRA hub aims to strengthen innovation and support for life sciences in Northern Ireland.
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CTIS Quarterly Meeting
8th May 2026A range of resources from the recent EMA meeting, 30th April 2026
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EMA Human Medicines Highlights - May 2026
8th May 2026Out Now.
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CTIS Newsletter - April 2026
30th April 2026Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
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MHRA Safety Roundup: April 2026
30th April 2026Latest updates on medicine and medical device safety from the MHRA.
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MHRA hires top global tech talent to modernise regulatory systems
30th April 2026New digital expertise aims to strengthen how medicines and devices are regulated in the UK.
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Diagnostic radiopharmaceutical IMPs and GMP requirements
28th April 2026Guidance clarifies GMP expectations for diagnostic radiopharmaceuticals used in clinical trials.
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ICH E6 Good Clinical Practice guidance now in force in the UK
28th April 2026Updated GCP guidance aligned with ICH E6 is now officially in force for UK clinical trials.
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Launch of clinical trial reforms
28th April 2026UK government announces major reforms to improve the speed and efficiency of clinical trials.
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Notification of serious breaches of GCP or the trial protocol
28th April 2026Guidance outlines how and when to report serious breaches in clinical trials.
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Route B substantial modifications pilot: the results are in
27th April 2026MHRA shares findings from its pilot to improve how substantial clinical trial modifications are handled.
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OpenAI launches GPT-Rosalind for life sciences workflows
21st April 2026A new OpenAI model aims to speed up biology and drug development research while keeping scientists firmly in control.
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National AI Commission: Ask Me Anything
20th April 2026Insights from the National AI Commission addressing key questions on AI’s future in the UK.
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Shaping the future of healthcare - MHRA Blog
17th April 2026How regulatory innovation and collaboration are driving the future of healthcare.
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Clinical trials for medicines: roles and responsibilities
16th April 2026MHRA guidance outlining who is responsible for what in UK clinical trials.
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MHRA Annual Accountability Review Minutes 2024 to 2025 Published
16th April 2026Key discussions and performance updates from MHRA’s annual accountability review.
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How to seize the growing opportunities of AI and technology ahead
14th April 2026MHRA highlights how organisations can embrace AI and emerging technologies in regulated environments.
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MHRA/NICE Aligned decisions, faster patient access Webinar
10th April 2026Available to view now.
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CTIS - New FAQ Document Released
9th April 2026EMA would like to inform you of the publication of a new document of frequently asked questions (FAQ) for sponsors on the Clinical Trials Information System (CTIS).
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EMA Veterinary Medicines Highlights - April 2026
9th April 2026Out now
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Access Consortium sets 2026 priorities to accelerate work sharing and improve patient access to innovative medicines
8th April 2026Global regulators outline plans to streamline collaboration and speed up access to new treatments.
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Cities unite to put One Health into action
8th April 2026Urban leaders commit to collaborative approaches linking human, animal and environmental health.
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MHRA expands AI Airlock programme with £36 million funding boost over three years
8th April 2026New investment aims to accelerate safe adoption of AI in healthcare regulation.
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Strengthening One Health through coordinated action on implementation, science, policy and financing
8th April 2026WHO highlights the need for joined-up action to tackle global health threats across sectors.
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UK and US deepen regulatory cooperation on medical devices
8th April 2026Strengthened partnership aims to align approaches and support innovation in medical devices.
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Updated and expanded ICH Q9(R1) Quality Risk Management briefing pack now available
8th April 2026New materials support implementation of revised quality risk management principles.
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Approving Clinical Investigations in the UK
2nd April 2026Guidance outlines the process for gaining approval to conduct clinical investigations in the UK.
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EMA Inspectors Working Group 3-Year Work Plan
2nd April 2026EMA outlines priorities and objectives for inspection activities over the next three years.
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EMA Newsletters Available Now
2nd April 2026Industry Highlights edition 1 and Clinical Trials Highlights edition 31.
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Environmental Risk Assessments in Medicines
2nd April 2026UK guidance sets out requirements for assessing environmental risks of medicinal products.
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UK Guidance on Compliance with ICH E6 Good Clinical Practice
2nd April 2026Updated UK guidance outlines expectations for complying with ICH E6 Good Clinical Practice in clinical trials.
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UK Guidance on Quality and Risk Proportionality in Clinical Trials
2nd April 2026New UK guidance highlights a proportionate approach to quality and risk management in clinical trials.
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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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