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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FDA - Draft Guidance - Integrating Randomised Controlled Trials for Drug and Biological Products Into Routine Clinical Practice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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Efpia - Annual Regulatory GMP/GDP Inspection Survey 2023 Data
21st June 2024A report by European Federation of Pharmaceutical Industries and Associations
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FDA-NIH - Glossary for Clinical Research
21st June 2024Open for comment now.
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ICH - M14 Guideline Available for Comment
21st June 2024ICH M14 Guideline on General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines.
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EMA - Faster access to clinical trial information in Europe
18th June 2024The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable today in Europe.
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EMA - Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape
17th June 2024Article co-authored by EMA.
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EMA - Generating clinical evidence for treatment and prevention options for long COVID
17th June 2024Article co-authored by EMA
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MHRA - Guidance Released Machine learning medical devices: transparency principles
14th June 202413th June 2024
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MHRA - Updated Guidance Software and artificial intelligence (AI) as a medical device
14th June 2024This guidance provides access to important Software Group outputs that might be of assistance.
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EMA - ACT EU launching two advice pilots
13th June 2024The Accelerating Clinical Trials in the EU (ACT EU) initiative is today (10th June 2024) launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe.
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FDA - Research on AI/ML-Based Medical Devices
13th June 2024CDRH’s Office of Science and Engineering Laboratories (OSEL) Information.
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ICH - Assembly Meeting
13th June 2024ICH Assembly Meeting Write Up, Fukuoka, Japan, June 2024 The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 & 5 June 2024, in Fukuoka, Japan in parallel of meetings of 13 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. The ICH continues to expand and welcomed ANMAT, Argentina and JFDA, Jordan as new ICH Members, bringing ICH to a total of 23 Members and 35 Observers.
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ICH E6(R3) EWG Work Plan
11th June 2024Published Work Plan
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EMA - Annual Report 2023
6th June 2024Published on 30th May 2024 EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive features, the report offers insights into EMA's strategic initiatives and priority areas that guided its work in 2023.
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EMA - Human Medicines Highlights Newsletter
6th June 2024May 2024 The newsletter for patients, consumers and healthcare professionals
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
6th June 202427-30 May 2024
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)
6th June 202421st - 22nd May 2024
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FDA - Platform Technology Designation Program for Drug Development
6th June 2024Guidance Document available for comment
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FDA - Processes and Practices Applicable to Bioresearch Monitoring Inspections
6th June 2024The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”
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FDA - Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of BIMO Inspections
6th June 2024Guidance document open for comment.
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FDA Roundup: 4th June 2024
6th June 2024An at-a-glance summary of news from around the agency.
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ICH - M12 Guideline reaches Step 4 of the ICH Process
6th June 2024The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.
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EMA - Horizon scanning on veterinary novel therapies
30th May 2024The European Medicines Agency has launched a horizon scanning survey on veterinary novel therapies.
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