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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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FDA - In September 2024, the U.S. FDA issued a Warning Letter to the Indian company MMC Healthcare Ltd.
17th October 2024Inspected March 2024
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EMA - Veterinary Scientific Guidance Update
4th October 2024EMA adopted and draft guidance
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VICH - Veterinary Scientific Guidance Update
4th October 2024New Guidance
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FDA - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
2nd October 2024This guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs.
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MHRA - webinar on Implementing the new UK Clinical Trials regulations
30th September 2024Registration now open.
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MHRA - Drug Safety Update Newsletter
27th September 2024September 2024
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World Health Organization - 2024 Guidance for Best Practices in Clinical Trials
26th September 2024The World Health Organisation (WHO) has developed some guidance on best practices for clinical trials was developed following extensive global input, including public consultations.
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MHRA - An update on our plans for Med Tech regulatory change
25th September 2024New Blog Post
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MHRA - AI Airlock pilot call for applications
24th September 2024Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
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MHRA - Wholesalers and manufacturers guidance following agreement of the Windsor Framework
13th September 2024Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
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EMA - Human Medicines Newsletter
5th September 2024August 2024
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FDA - Bioresearch Monitoring Technical Conformance Guide
5th September 2024Final guidance available
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FDA - New Final Guidances Issued by Center for Veterinary Medicine
5th September 2024CVM GFI #63 (VICH GL1) and CVM GFI #64 (VICH GL2)
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FDA - Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
5th September 2024Final Guidance Released
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FDA - Roundup, 30th August 2024
5th September 2024An at-a-glance summary of news from around the agency
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FDA - Warning Letter to Italian Company
5th September 2024The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. 3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
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MHRA - Advertising Investigations
5th September 2024Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
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MHRA - Appointments of four MHRA Non-Executive Directors extended until 31 August 2025
5th September 2024Extended from 1 September 2024 until 31 August 2025.
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MHRA - Consultation on Statutory Fees
5th September 2024Proposals on ongoing cost recovery
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MHRA - Pharmacovigilance following agreement of the Windsor Framework
5th September 2024MHRA have published information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
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WHO - Guidance aims to curb antibiotic pollution from manufacturing
5th September 2024New global guidance released
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MHRA - Performance Metrics Published
16th August 2024MHRA performance metrics for clinical trials and established medicines assessment.
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EMA - Veterinary Scientific Guidance Update - Adopted and Draft Guidance
14th August 2024New adopted and draft guidelines relating to Veterinary Products
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MHRA - Medicines Pipeline data
14th August 2024New Guidance Published
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MHRA - Pre-submission Advice & Support
14th August 2024New Guidance Published
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VICH - Veterinary Scientific Guidance Updates
14th August 2024Updates from 2024
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EMA - CTIS Simplification Force
13th August 2024As part of the work of the CTIS Simplification Force, EMA are proposing some changes to the CTIS roles matrix.
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EMA - Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 5)
6th August 2024Released 26th July 2024
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EMA - Real-world evidence framework to support EU regulatory decision-making
1st August 20242nd report on the experience gained with regulator-led studies from February 2023 to February 2024.
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MHRA - Drug Safety Update
1st August 2024Volume 18, 1st August 2024
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HRA - Demographic Survey Report
31st July 2024The HRA community were asked to complete a diversity and inclusion survey. The results help build a picture of who HRA's members are, help them understand who isn’t part of their community, and help them to take action so that members better reflect the diversity of society.
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HMA/EMA - Multi-Stakeholder Workshop on AI
24th July 20245th November 2024
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EMA public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimisation measures and its Addendum II
22nd July 2024The European Medicines Agency (EMA) is hosting an online event to launch the revised guideline on good pharmacovigilance practices (GVP) Module XVI and its Addendum II. The event will provide an overview of how stakeholder comments from the public consultation on these documents have been addressed. This will be followed by a questions and answers session for answering audience questions.
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EMA - Article on RWE
19th July 2024Co-authored by EMA and published in the Clinical Pharmacology & Therapeutics journal.
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eClinical Forum - New version of eCF Requirements and Webinar
19th July 2024The eClinical Forum is releasing this version (V2023.3PR) as a service to the eClinical Community.
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EMA - ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines
9th July 2024This reflection paper was co-developed by the European Medicines Agency, the United States of America's (USA) Food and Drug Administration (FDA), and Health Canada and adopted in June 2024 by the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024
9th July 202410 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
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FDA - Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
9th July 2024Draft Guidance Released
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FDA - M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
9th July 2024Draft Guidance Released
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FDA - Updates to Guidance to Further Empower Companies to Address the Spread of Misinformation
9th July 2024The U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health.
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HMA-EMA - 5th HMA/EMA Big Data Stakeholder Forum
9th July 2024Announced for Thursday, 28 November 2024.
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MHRA - Procurement at MHRA
9th July 2024MHRA have released information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.
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WHO - MeDevIS platform announced
9th July 2024The first global open access clearing house for information on medical devices.
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WHO - Updates to laboratory biosecurity guidance
9th July 2024WHO recently issued updated guidance for national authorities and biomedical laboratories to manage biological risks.
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