Recent News

If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.

• EMA - Human Medicines Highlights - November 2024

  19th November 2024

  November 2024 Edition

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• MHRA - MHRA GCP & Laboratories Symposium

  18th November 2024

  11th - 12th Feb 2025

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• ICH E6(R3) Annex 2 - Draft Released

  15th November 2024

  The 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 2024

  Learn how the EDQM protects consumer health

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• EMA - First certification of a veterinary vaccine platform technology master file

  14th November 2024

  Platform technologies enable rapid response to emerging infectious disease threats

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• EMA - Meeting Minutes

  14th November 2024

  PRAC, CVMP and CHMP Meeting Minutes

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• EMA - Public consultation - list of enabling tools

  14th November 2024

  Comments 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• FDA - Draft Guidance - Integrating Randomised Controlled Trials for Drug and Biological Products Into Routine Clinical Practice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 2024

  Submit comments by 17th December 2024

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• FDA - Final Guidance Conducting Clinical Trials With Decentralised Elements

  14th November 2024

  This 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 2024

  The 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 2024

  This 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 2024

  Watch 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 2024

  The 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 2024

  The 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 2024

  Collaboration 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 2024

  An 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 2024

  The 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 2024

  Latest CTIS newsletter released

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• MHRA - Emerging Roadmap and transition provisions

  1st November 2024

  New 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 2024

  Inspected March 2024

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• EMA - Veterinary Scientific Guidance Update

  4th October 2024

  EMA adopted and draft guidance

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• VICH - Veterinary Scientific Guidance Update

  4th October 2024

  New Guidance

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• FDA - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

  2nd October 2024

  This 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 2024

  Registration now open.

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• MHRA - Drug Safety Update Newsletter

  27th September 2024

  September 2024

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• World Health Organization - 2024 Guidance for Best Practices in Clinical Trials

  26th September 2024

  The 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 2024

  New Blog Post

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• MHRA - AI Airlock pilot call for applications

  24th September 2024

  Apply 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 2024

  Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework

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• EMA - Human Medicines Newsletter

  5th September 2024

  August 2024

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• FDA - Bioresearch Monitoring Technical Conformance Guide

  5th September 2024

  Final guidance available

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• FDA - New Final Guidances Issued by Center for Veterinary Medicine

  5th September 2024

  CVM 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 2024

  Final Guidance Released

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• FDA - Roundup, 30th August 2024

  5th September 2024

  An at-a-glance summary of news from around the agency

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• FDA - Warning Letter to Italian Company

  5th September 2024

  The 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 2024

  Decisions 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 2024

  Extended from 1 September 2024 until 31 August 2025.

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• MHRA - Consultation on Statutory Fees

  5th September 2024

  Proposals on ongoing cost recovery

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• MHRA - Pharmacovigilance following agreement of the Windsor Framework

  5th September 2024

  MHRA 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 2024

  New global guidance released

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• MHRA - Performance Metrics Published

  16th August 2024

  MHRA performance metrics for clinical trials and established medicines assessment.

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• EMA - Veterinary Scientific Guidance Update - Adopted and Draft Guidance

  14th August 2024

  New adopted and draft guidelines relating to Veterinary Products

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• MHRA - Medicines Pipeline data

  14th August 2024

  New Guidance Published

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• MHRA - Pre-submission Advice & Support

  14th August 2024

  New Guidance Published

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• VICH - Veterinary Scientific Guidance Updates

  14th August 2024

  Updates from 2024

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• EMA - CTIS Simplification Force

  13th August 2024

  As 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 2024

  Released 26th July 2024

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• EMA - Real-world evidence framework to support EU regulatory decision-making

  1st August 2024

  2nd 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 2024

  Volume 18, 1st August 2024

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• HRA - Demographic Survey Report

  31st July 2024

  The 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 2024

  5th 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 2024

  The 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 2024

  Co-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 2024

  The 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 2024

  This 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 2024

  10 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 2024

  Draft 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 2024

  Draft Guidance Released

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• FDA - Updates to Guidance to Further Empower Companies to Address the Spread of Misinformation

  9th July 2024

  The 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 2024

  Announced for Thursday, 28 November 2024.

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• MHRA - Procurement at MHRA

  9th July 2024

  MHRA 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 2024

  The first global open access clearing house for information on medical devices.

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• WHO - Updates to laboratory biosecurity guidance

  9th July 2024

  WHO 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 2024

  A report by European Federation of Pharmaceutical Industries and Associations

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• FDA-NIH - Glossary for Clinical Research

  21st June 2024

  Open for comment now.

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• ICH - M14 Guideline Available for Comment

  21st June 2024

  ICH 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 2024

  The 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 2024

  Article co-authored by EMA.

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• EMA - Generating clinical evidence for treatment and prevention options for long COVID

  17th June 2024

  Article co-authored by EMA

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• MHRA - Guidance Released Machine learning medical devices: transparency principles

  14th June 2024

  13th June 2024

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• MHRA - Updated Guidance Software and artificial intelligence (AI) as a medical device

  14th June 2024

  This 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 2024

  The 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 2024

  CDRH’s Office of Science and Engineering Laboratories (OSEL) Information.

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• ICH - Assembly Meeting

  13th June 2024

  ICH 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 2024

  Published Work Plan

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• EMA - Annual Report 2023

  6th June 2024

  Published 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 2024

  May 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 2024

  27-30 May 2024

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• EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)

  6th June 2024

  21st - 22nd May 2024

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• FDA - Platform Technology Designation Program for Drug Development

  6th June 2024

  Guidance Document available for comment

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• FDA - Processes and Practices Applicable to Bioresearch Monitoring Inspections

  6th June 2024

  The 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 2024

  Guidance document open for comment.

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• FDA Roundup: 4th June 2024

  6th June 2024

  An 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 2024

  The 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 2024

  The European Medicines Agency has launched a horizon scanning survey on veterinary novel therapies.

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