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EMA - CTIS Newsflash Replaced with Clinical Trials Highlights Newsletter
24th June 2025From July 2025
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MHRA - AI Airlock Phase 2 application
24th June 2025The call for application for phase 2 of the AI Airlock is now open.
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MHRA - AI breakthroughs drive expansion of ‘Airlock’ testing programme
24th June 2025AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
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MHRA - Fast, Expert and Open – how the MHRA is poised to become a global leader in risk-proportionate regulation
19th June 2025New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.
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MHRA - Electronic Common Technical Document (eCTD) submissions update
18th June 2025Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.
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MHRA - First major overhaul of medical device regulation comes into force across Great Britain
16th June 2025New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
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MHRA - Human Medicines Highlights June 2025
16th June 2025The newsletter for patients, consumers and healthcare professionals
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MHRA - Unprecedented boost for clinical trials under 10 Year Health Plan
16th June 2025Millions will take part in clinical trials under the 10 Year Health Plan which will speed up clinical research.
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EMA - Overview of comments received on ICH M11 Technical Specification Updated Step 2b
12th June 2025Comments Published
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Pharmacovigilance News - March 2025 to May 2025
12th June 2025The RQA GPvP Committee have collated relevant pharmacovigilance news and will share quarterly.
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MHRA - Decentralised Manufacture Guidance Documents
11th June 2025Updated and published guidance on decentralised manufacture released.
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MHRA - Human medicines Modular Manufacture and Point of Care regulations 2025: Overview
11th June 2025Information to help you understand and prepare for the main regulatory changes that The Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 will introduce for the manufacture of medicines at - or close to - the point of patient care.
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MHRA - Documentation for implementation of data requirements under the new Post-Market Surveillance regulations
10th June 2025Documentation changed to support changes to Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs)
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MHRA - MHRA launches new digital hub in Leeds to drive innovation and regional growth
6th June 2025A new digital hub in Leeds is being launched by the Medicines and Healthcare products Regulatory Agency (MHRA), marking a significant step in the agency’s long-term commitment to advancing innovation and strengthening its presence across the UK.
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MHRA - RegulatoryConnect Webinar Added
5th June 202522nd May 2025 Webinar added to page
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MHRA Blog - A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors
4th June 2025Blog post by Dr Christopher Watson, 4 June 2025
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FDA - FDA Launches Agency-Wide AI Tool to Optimise Performance for the American People
3rd June 2025The U.S. Food and Drug Administration (FDA) launches Elsa.
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EMA - Veterinary Medicines Highlights
2nd June 2025May 2025 Quarterly news, activities and interviews from EMA Veterinary Medicines Division
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MHRA - Digital mental health technology webinar
2nd June 2025The Wellcome Trust has funded a 3-year project focusing on effective regulation and evaluation of digital mental health technology.
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MHRA - MHRA Licensing National assessment procedure for medicines webinar
2nd June 2025Recording from 6th May 2025 now available
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MHRA - Safety Roundup: May 2025
2nd June 2025Now available to download
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MHRA Newsletter May 2025
2nd June 2025The essential industry newsletter where we update you on our most recent activities.
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EDQM - Launch of the all-digital 12th edition of the European Pharmacopoeia
27th May 2025Soon available on an online platform.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025
27th May 2025Highlights from meeting 19-22 May 2025
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 May 2025
27th May 2025Highlights from 13-15 May 2025
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MHRA - First MHRA Board meeting held in Scotland
27th May 2025Underlining agency’s commitment to regional health equality and growth
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MHRA - Launches of Real-world Data Consultation
27th May 2025MHRA highlights “remarkable” progress and launches real-world data consultation on International Clinical Trials Day
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MHRA Blog - Are you prepared for Post-Market Surveillance?
27th May 2025Blog Post by Joseph Burt, May 2025
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MHRA - Consultation Results on ICH E6(R3)
13th May 2025The ICH Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) GCP guideline.
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HRA - Clinical trial regulations reform
7th May 2025The Health Research Authority (HRA) has been working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to amend the Medicines for Human Use (Clinical Trials) Regulations 2004.
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HRA - Our work as part of UKCRD to streamline and reform study set-up
7th May 2025The Department of Health and Social Care (DHSC) has established the UK Clinical Research Delivery (UKCRD) programme, a cross-sector programme of work aimed at creating a faster, more efficient, more accessible and more innovative clinical research delivery system – making the UK a world leader in clinical trials.
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EMA - New guidance for HMA-EMA Catalogues of real-world data sources and studies published
29th April 2025We are pleased to inform you about the publication of new guidance that provide valuable insights on best practices for the users of the HMA-EMA Catalogues of real-world data sources and studies (RWD Catalogues): Good practice guide - provides regulators, researchers and other stakeholders with recommendations on effectively using the Catalogues to identify and assess the suitability of data sources for studies on the use, safety, and effectiveness of medicines. The guide underwent public consultation and has been adopted by the Methodology Working Party and the Committee for Medicinal Products for Human Use (CHMP). A new user guide - primarily aimed at users creating data records in the Catalogues, this guide includes detailed instructions on submitting and maintaining records, along with descriptions of the metadata fields. Updated list of metadata elements - includes an improved description of data sources and study records based on users’ feedback. The RWD Catalogues, which were launched a year ago, enhance transparency and access to real-world data for research and regulatory purposes. They serve two key roles: Open access resource: the Catalogues allow for the pre-registration of RWD studies in Europe and beyond, promoting transparency and reproducibility. Data sources hub: they act as a central resource for regulators, companies, and researchers to identify suitable data sources to investigate the use, safety, and effectiveness of medicines. Since their launch in February 2024, the Catalogues have steadily grown, now featuring 3053 registered studies and 246 data sources. Researchers can add information about their studies in the Catalogues following this link: Catalogue of RWD studies. Data holders can add information about their data source in the Catalogues following this link: Catalogue of RWD sources. More information: Real-world evidence | European Medicines Agency (EMA)
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MHRA - MHRA Licensing – National assessment procedure for medicines webinar
29th April 20256th May 2025
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EMA - Clinical Trials Highlights April 2025
23rd April 2025Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
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EMA - ICH Q1 Draft Guideline & Step 2
23rd April 2025Presentation Now Available on the ICH Website
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EMA - GMP Q&A Updated
16th April 2025EMA has published updated GMP Q&A's.
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025
16th April 2025Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025
16th April 2025PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use
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EMA/HMA - Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU
16th April 2025EMA and HMA encourage strengthening Europe’s production capacity
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MHRA - Risk minimisation measures for medicines Guidance
16th April 2025Guidance for healthcare professionals on risk minimisation options for medicines.
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MHRA Blog - MedTech regulatory reform and the importance of partnerships
16th April 2025Medical technologies will play a critical role in delivering the government’s 10 Year Health Plan and its three shifts: hospital to community; analogue to digital; and sickness to prevention.
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WHO - WHO Member States conclude negotiations and make significant progress on draft pandemic agreement
16th April 2025Proposal to be submitted to World Health Assembly in May for consideration
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MHRA - Clinical Trials regulations signed into law
12th April 202512-month roll-out begins today for the biggest regulatory shake up of clinical trials in 20 years
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EMA - Big Data Highlights April 2025
10th April 2025Network Data Steering Group quarterly news on data and AI in medicines regulation
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MHRA - Analysis of UK clinical trial applications finds new opportunities to drive medical breakthroughs for patients
10th April 2025Press release, 9th April 2025
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MHRA - WHO confirms MHRA to continue playing vital role in ensuring the quality of global biological medicines
10th April 2025News story, 9th April 2025
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EMA - CTIS Designated as a Primary Registry
3rd April 2025by WHO
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MHRA - Blog Post by Dame June Raine
1st April 2025How innovations are transforming regulation and speeding new treatments to healthcare
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MHRA - MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner
1st April 2025Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted an event for the seven newly established Centres of Excellence for Regulatory Science and Innovation June Raine, MHRA Chief Executive, said: “At our CERSIs event this week, the depth of expertise was impressive and there was real excitement about the progress being made. The discussions highlighted a strong commitment to improving access to innovation for patients, shared with our partners Innovate UK, Office of Life Sciences and the MRC. Through the CERSIs, we have a major opportunity to drive advances in regulatory science in the UK – now is the time to turn that potential into action.”
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MHRA - Updates to Innovative Licensing and Access Pathway (ILAP) Guidance
1st April 2025Updates have been made to these pages.
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MHRA - March 2025 Newsletter
28th March 2025The essential industry newsletter where we update you on our most recent activities
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MHRA - Performance Data
28th March 2025Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
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EMA - Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028
26th March 2025EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS).
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)
26th March 202511-13 March 2025
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EMA - interim report on the scientific advice pilot for high-risk medical devices.
26th March 2025Added 24th March 2025
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FDA - FDA Roundup 21st March 2025
26th March 2025An at-a-glance summary of news from around the agency:
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ICH - The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process
26th March 2025Announced 20th March 2025 The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025. The eCTDv4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group on the eCTDv4.0 Implementation Package, and further to receiving new Change Requests, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.9. The eCTDv4.0 Q&A v1.9 is available for download on the ICH ESTRI page for eCTD v4.0 here.
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MHRA - MHRA launches new monthly safety bulletin
26th March 2025Sign up today
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MHRA - Safety communications concerning medicines, medical devices and other healthcare products
26th March 2025New Guidance
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MHRA Blog - Exploring AI in Healthcare: Insights from the AI Airlock Pilot
26th March 2025Blog post by Jincy Robin, 26th March 2025
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
26th March 202510-13 March 2025
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WHO - Announces new collaborating centre on AI for health governance
26th March 2025The World Health Organisation (WHO) designated the Digital Ethics Centre at Delft University of Technology in the Netherlands as a WHO Collaborating Centre on artificial intelligence (AI) for health governance.
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EMA - Small and Medium-sized Enterprises (SMEs) Highlights
25th March 2025March 2025
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EMA - Human Medicines Highlights
20th March 2025The newsletter for patients, consumers and healthcare professionals, March 2025 Edition
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EMA - ICH M11 Guideline
20th March 2025ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
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MHRA - Decentralised manufacture hub - New Regulation
20th March 2025Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025.
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EMA - Centralised Procedures Q&A Document Updated
11th March 2025Updated Feb 2025
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EMA - Extension to GDP Regulatory Expectations and Certificates Ends
11th March 2025The GMP / GDP Inspectors Working Group extended the validity of GDP certificates as a temporary regulatory flexibility in 2021. The working group prolonged this extension until the end of 2024. From 2025, this extension no longer applies.
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EMA - Veterinary Medicines Highlights March 2025
10th March 2025The 20th edition of the Veterinary Medicines newsletter.
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MHRA - Government response to statutory fees
10th March 2025MHRA consultation on statutory fees: proposals on ongoing cost recovery The MHRA held a public consultation on proposed amendments to its statutory fees. The consultation ran between 29 August 2024 and 24 October 2024 and was held jointly with the Department of Health in Northern Ireland, in accordance with Section 45(1) of the Medicines and Medical Devices Act 2021. This document summarises the responses to the consultation and outlines our response to feedback and proposed next steps.
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MHRA - New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infections
10th March 2025In a UK-first, the Medicines and Healthcare products Regulatory Agency (MHRA) and Barts Health NHS Trust have developed a DNA sequencing approach that can be implemented onsite in hospitals so they can diagnose bacterial infections faster and more accurately.
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MHRA - Board Meeting - March 2025
5th March 2025The next MHRA Board Meeting held in public will be conducted virtually by webinar.
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MHRA - New Chief Executive appointed
4th March 2025Following an extensive recruitment process, Mr Tallon will begin the role from 1 April 2025.
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EMA - CTIS Newsflash 25th February 2025
26th February 2025This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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UKRI - Report calls for action to tackle decline in clinical researchers
26th February 2025Urgent action is required to address falling numbers of clinical researchers and meet the needs of the nation’s health and economy, according to a new report
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EMA - certification for its environmental efforts
24th February 2025Eco-Management and Audit Scheme (EMAS) certificate is a mark of environmental excellence in the EU
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MHRA Blog - New Leadership and a focus on Software
24th February 2025Rob Reid, 21 February 2025
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MHRA - Updates to PV Exceptions and Modifications Document
20th February 2025Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
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EMA - CTIS Newsflash 11th Feb 2025
19th February 2025This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Clinical Trials Highlights Feb 2025
19th February 2025Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
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EMA - Human Medicines Highlights Feb 2025
19th February 2025The newsletter for patients, consumers and healthcare professionals
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EMA - Regular procedure for scientific advice on certain high-risk medical devices
12th February 2025Manufacturers can request advice on their medical device clinical development programme
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FDA - Institutional Review Board (IRB) Written Procedures
12th February 2025Guidance for Institutions and IRBs OHRP's and FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes OHRP's and FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
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MHRA - Exceptions and modifications to the EU guidance on good pharmacovigilance practices
12th February 2025This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) - guidance notes updated.
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MHRA - MHRA Real-World Evidence Scientific Dialogue Programme
12th February 2025Link to Expression of Interest form added 10th Feb. 2025
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MHRA - Implementation of ICH E6(R3)
11th February 2025Confirmation of when it is expected to come into force.
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MHRA - Digital mental health technology: qualification and classification Guidance
4th February 2025Released 3rd Feb 2025
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HRA - Developing a New Strategy Blog
3rd February 2025Our current strategy was written to last three years, and now we’re planning a new strategy, starting in 2025, which will set out what we are going to do to deliver our mission over the next three years.
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HRA - Shaping the future of UK life sciences
3rd February 2025Blog post - how regulators can support growth which helps everyone
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MHRA - Current approaches to product marking
3rd February 2025New guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors.
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EMA - CTIS Newsflash 28th Jan 2025
30th January 2025New issue released.
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EMA - European Shortages Monitoring Platform Operational
30th January 2025European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU
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MHRA - Drug Safety Update Jan 2025
30th January 2025Out now.
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MHRA - Graduate Scheme
30th January 2025Detailed released.
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MHRA - Innovative Licensing and Access Pathway (ILAP)
30th January 2025Full details have been published today of the refreshed UK-wide Innovative Licensing and Access Pathway (ILAP), that will offer a clearer, more streamlined and integrated process for developers to help get transformative new medicines to patients in the National Health Service (NHS) in the shortest time possible.
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ICH - E6(R3) Training Available
27th January 2025The ICH E6(R3) Introductory Training Presentation is now available on the ICH website
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ICH - ICH E6(R3) - Step 5
27th January 2025ICH E6(R3) (Principles and Annex 1), has reached Step 5 and will be effective from June 2025, and adopted on the 23rd July. ICH E6 (R2) remains in effect until 11 June 2025.
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EMA - CVMP Meeting highlights 14-15 Jan 2025
21st January 2025Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 January 2025
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EMA - PRAC Meeting Highlights - 13-16 Jan 2025
21st January 2025Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2025
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MHRA - Advertising investigations: December 2024
21st January 2025Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines - published 20th Jan 2025.
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PIC/S - AUDA-NEPAD - a new PIC/S Associated Partner Organisation
21st January 2025The African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD) becomes a new PIC/S Associated Partner Organisation
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WHO - United States to Withdraw
21st January 2025US intends to withdraw from WHO
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EMA - ICH E6(R3) Revision Workshop and Annex 2
20th January 202519th-20th February 2025
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MHRA - Medical Devices Regulation 2024
20th January 2025The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation Medical devices: periodic safety update report (PSUR)
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EMA - Human Medicines Highlights Newsletter, Jan 2025
16th January 2025Out now
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EMA - Concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use.
15th January 2025Open for consultation
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EMA - IRIS Documentation
15th January 2025Released January 2025
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FDA - Advanced Manufacturing Technologies Designation Program
15th January 2025Final guidance released
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FDA - Roundup, 14th January 2025
15th January 2025An at-a-glance summary of news from around the agency
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MHRA - Good Clinical and Laboratory Practice Symposia
15th January 202511th and 12th February 2025
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MHRA - ICH M15 Model Informed Drug Development (MIDD) Guideline
15th January 2025Blog post by Essam Kerwash The International Council for Harmonisation (ICH) M15 Model informed Drug development (MIDD) Guideline has reached Step 2b and is available for public consultation. As a clinical pharmacology assessor at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I was involved with the development of this guidance.
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MHRA - MHRA guidance on new Medical Devices Post-Market Surveillance requirements
15th January 2025A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).
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EMA - CTIS Newsflash - 14th January 2025
14th January 2025Out now!
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ICH - ICH E6 (R3) - Step 4
14th January 2025The ICH E6(R3) Guideline reached Step 4 of the ICH process on 6 January 2025.
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MHRA - Patient Involvement Strategy: an assessment of progress
14th January 2025The Medicines and Healthcare products Regulatory Agency (MHRA) published its first Patient Involvement Strategy in October 2021, covering the period to 2025.
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MHRA - Real-World Evidence Scientific Dialogue Programme
14th January 2025A programme to help facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and Health Technology Assessment (HTA) evaluations relevant to the UK.
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FDA - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
8th January 2025Open for Consultation
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PIC/S - Two guidance documents for inspectors on remote assessments
8th January 2025"Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment.
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