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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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EMA - CTIS Newsflash, 17th December 2024
17th December 2024Key updates on CTIS and links to useful reference materials.
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MHRA - Small and Medium-sized Enterprises (SMEs) Highlights Newsletter
16th December 2024December 2024
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MHRA - Webinar on Modular Manufacture and Point of Care Regulations
13th December 202414:00 – 15:30 (GMT) on Tuesday 28 January 2025.
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EMA - Clinical Trials Highlights December 2024
12th December 2024New newsletter released
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 December 2024
12th December 2024Outcomes of the recent CVMP meeting
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FDA - FDA Roundup: 10th December 2024
12th December 2024An at-a-glance summary of news from around the agency
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ICH - ICH Q9(R1) IWG Updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers
12th December 2024Now available on the ICH website
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MHRA - MedRegs Blog, December 2024
12th December 2024Festive reflections on Med Tech
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MHRA - new clinical trials framework being laid in parliament today
12th December 2024Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today
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EMA - Data Quality Framework for EU medicines regulation: application to Real-World Data Public Consultation
11th December 2024The European Medicines Agency has published for public consultation a new document: Data Quality Framework for EU medicines regulation: application to Real-World Data.
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EMA - HMA-EMA Real-World Data (RWD) Catalogues Survey
11th December 2024Following their launch in February we are interested to know about your experience with the RWD Catalogues and how we could further improve them.
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EMA - The European Medicines Agency has published for public consultation the ICH Guideline for Good Clinical Practice E6(R3) Annex 2
11th December 2024Comments by 28th February 2025
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EMA - public consultation the ICH M15 Guideline on general principles for model-informed drug development
11th December 2024This guideline provides general recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development (MIDD).
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EMA - CTIS Newsflash, 3rd December 2024
5th December 2024New edition out now.
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EMA - Veterinary Medicines Highlights, December 2024
5th December 2024Quarterly news, activities and interviews from EMA Veterinary Medicines Division
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MHRA - Five Innovative AI Technology Trials
5th December 2024MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach
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MHRA - Final Call to Comply with Windsor Framework
2nd December 2024The MHRA issues final call to comply with Windsor Framework arrangements for medicines from January 2025
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OECD - Position Paper on Good Laboratory Practice and IT Security
2nd December 2024This position paper was developed by the OECD Working Party on Good Laboratory Practice (GLP) via a drafting group led by Denmark (Medical Products) and consisting of Austria, Belgium, Canada, France (Medical Products), Germany and Switzerland.
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World Medical Association announces adoption of the 2024 Revision of the Declaration of Helsinki
2nd December 2024Adopted in October 2024
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EMA - CTIS Newsflash - 19th November 2024
27th November 2024This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Three Public Consultations
26th November 2024The European Medicines Agency has published for public consultation two documents relating to Regulatory Science Research:
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MHRA - Regulating and evaluating digital mental health technologies
22nd November 2024Newsletter 2, November 2024
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MHRA - Implementing the new UK Clinical Trials regulations Webinar
21st November 2024Link available now.
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MHRA - Windsor Framework Webinar Recordings
21st November 2024Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
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EMA - Human Medicines Highlights - November 2024
19th November 2024November 2024 Edition
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MHRA - MHRA GCP & Laboratories Symposium
18th November 202411th - 12th Feb 2025
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ICH E6(R3) Annex 2 - Draft Released
15th November 2024The draft of ICH E6(R3) Annex 2 was released by ICH EWG and is available for public consultation from today.
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EDQM Podcast
14th November 2024Learn how the EDQM protects consumer health
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EMA - First certification of a veterinary vaccine platform technology master file
14th November 2024Platform technologies enable rapid response to emerging infectious disease threats
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EMA - Meeting Minutes
14th November 2024PRAC, CVMP and CHMP Meeting Minutes
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EMA - Public consultation - list of enabling tools
14th November 2024Comments to be provided by 30th November 2024
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FDA - Draft Guidance - Integrating Randomised Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
14th November 2024Submit comments by 17th December 2024
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FDA - Final Guidance Conducting Clinical Trials With Decentralised Elements
14th November 2024This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralised elements in clinical trials.
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ICH - Assembly Meeting, Montréal, Canada, November 2024
14th November 2024The Assembly of the International Council for Harmonisation (ICH) met in-person on 5 & 6 November 2024, in Montréal, Canada in parallel of meetings of 11 Working Groups and 1 Discussion Group, and preceded by meetings of the ICH Management Committee (MC) and the MedDRA MC.
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ICH - Training Programme for Q8/Q9/Q10
14th November 2024This training material is comprised of a comprehensive presentation which addresses the implementation of the three guidelines, ICH Q8(R1), ICH Q9(R1) and ICH Q10, and how they work together.
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MHRA - Clinical Trials Regulations webinar recordings
14th November 2024Watch the MHRA webinar on Implementing the new UK Clinical Trials regulations, which took place on Tuesday 15 October 2024.
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MHRA - Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices
14th November 2024The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.
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MHRA - views on pre-market regulations for medical devices
14th November 2024The MHRA seeks views on pre-market regulations for medical devices to improve patient access and strengthen patient safety
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RQA - Collaboration Agreements
14th November 2024Collaboration is always high on the agenda; RQA has several initiatives in the pipeline, with many more under discussion.
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FDA - Roundup - 8th November 2024
8th November 2024An at-a-glance summary of news from around the agency.
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MHRA - Statement of policy intent: relaunch of the Innovative Licensing and Access Pathway
6th November 2024The Innovative Licensing and Access Pathway (ILAP) aims to get the most transformative new medicines to patients in the National Health Service (NHS) more quickly.
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EMA - CTIS Newsletter - 5th November 2024
5th November 2024Latest CTIS newsletter released
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MHRA - Emerging Roadmap and transition provisions
1st November 2024New MHRA Blog Post
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