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100 Years of Protecting Patients Through Biological Standards for Medicines
15th October 2025On World Standards Day, 14th October 2025, the MHRA commemorates a century of ensuring the safety, efficacy, and consistency of medicines and vaccines through biological standards.
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Dr Nicola Rose: A New Antibiotic Is Positive News – But It Will Take More to Stay Ahead of Superbugs
15th October 2025The MHRA's Interim Executive Director of Science and Research discusses the approval of gepotidacin, the UK's first new antibiotic for urinary tract infections in nearly 30 years, and the broader challenge of combating antibiotic resistance.
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Veterinary Medicines Highlights – Issue 22
14th October 2025The European Medicines Agency (EMA) has released the 22nd edition of its quarterly newsletter, providing updates on veterinary medicines regulation as of October 2025.
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A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors
10th October 2025The MHRA explores the unique challenges of supplying medicines to remote locations via air and sea, emphasising compliance with Good Distribution Practice (GDP).
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EMA Management Board Highlights: October 2025
10th October 2025The European Medicines Agency (EMA) Management Board convened on 2nd October 2025, reviewing mid-year performance and endorsing strategic initiatives.
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EMA Seeks Public Input on Enhancing Patient Perspectives in Medicine Regulation
10th October 2025The European Medicines Agency (EMA) has released a draft reflection paper inviting public consultation on integrating patient experience data into the regulatory process.
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EMA's PRAC Meeting Highlights: 29th September – 2nd October 2025
10th October 2025The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) convened from 29th September to 2nd October 2025, addressing various aspects of medicine safety.
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FDA Issues Final Guidance on Assessing Drug Manufacturing Facilities Using Alternative Tools
10th October 2025The FDA has finalised guidance on employing alternative tools to evaluate drug manufacturing facilities in pending applications.
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MHRA Patient Safety Essay Competition 2025
10th October 2025The MHRA invites medical students and foundation doctors to explore how genetics can enhance prescribing safety and patient outcomes in the UK.
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MHRA Updates Guidance on Clinical Trials Involving In Vitro Diagnostic Devices
10th October 2025The MHRA has released updated guidance for conducting clinical trials that include in vitro diagnostic (IVD) devices.
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MHRA Updates Guidance on Clinical Trials Requiring Expert Advice
10th October 2025The MHRA has released updated guidance for clinical trials that necessitate expert advice from specialist groups or committees.
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MHRA Updates Guidance on Clinical Trials: Collection, Verification, and Reporting of Safety Events
10th October 2025The MHRA has released an updated version of its guidance on safety event management in clinical trials.
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MHRA Updates Guidance on Ending Clinical Trials
10th October 2025The MHRA has released updated guidance on the process for ending clinical trials, effective from 28th April 2026.
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MHRA Updates Guidance on Modifying Clinical Trial Approvals: Introduction of Route A and B Processes
10th October 2025The MHRA has updated its guidance on modifying clinical trial approvals, introducing Route A and B processes to streamline amendments.
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MHRA Updates Guidance on Non-Investigational Medicinal Products in Clinical Trials
10th October 2025The MHRA has released updated guidance on the use of non-investigational medicinal products (NIMPs) in clinical trials, effective from 28th April 2026.
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MHRA Updates Labelling Requirements for Investigational Medicinal Products (IMPs) in Clinical Trials
10th October 2025The MHRA has released updated guidance on labelling requirements for IMPs used in clinical trials, effective from 1st October 2025.
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MHRA and US FDA Forge New Collaboration on Medical Technologies and AI
10th October 2025The UK and US regulators have strengthened their partnership to accelerate innovation, enhance patient safety, and reduce market access barriers for medical technologies and AI-driven healthcare solutions.
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UK Clinical Trial Approval Times Halved with AI and Regulatory Reforms
10th October 2025The UK has reduced clinical trial approval times from 91 to 41 days, enhancing patient access to new treatments.
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WHO Launches Global Clinical Trials Forum to Strengthen Research Infrastructure
10th October 2025On 7th October 2025, the World Health Organization (WHO) officially launched the Global Clinical Trials Forum (GCTF), a collaborative network aimed at enhancing clinical trial environments and infrastructure globally.
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New Commission to Accelerate NHS Use of AI
26th September 2025The UK establishes a National Commission to expedite safe AI integration into the NHS.
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FDA Issues Final Guidance on Computer Software Assurance for Production and Quality System Software
25th September 2025The FDA has released final guidance to streamline software assurance in medical device manufacturing.
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GVP Regulatory News 2025
22nd September 2025Now Available
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MHRA - Looking to Our Future: Reflections on Strategic Choices Ahead for the MHRA
17th September 2025The MHRA reflects on its future priorities to strengthen healthcare regulation and innovation.
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MHRA - New Regulations for Clinical Trials: Join Our Route B Substantial Modifications Pilot
17th September 2025The MHRA launches a pilot to test streamlined processes for substantial modifications in clinical trials.
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MHRA and Department for Education Embed Medicine Safety into School Curriculum
17th September 2025The MHRA is working with schools to teach young people about safe medicine use.
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MHRA Blog: Decentralised Manufacturing: Emerging Considerations
15th September 2025The MHRA explores the growing role of decentralised manufacturing in pharmaceuticals and its regulatory implications.
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MHRA - MHRA Publishes Standardised Format for Medical Device Post-Market Surveillance Reports
9th September 2025The MHRA has released a standardised template to improve post-market surveillance of medical devices.
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MHRA Seeks Input on Prioritisation of Designated Standards
9th September 2025The MHRA is consulting stakeholders on how to prioritise standards for medical devices.
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FDA - Annual report on the State of Pharmaceutical Quality
3rd September 2025The annual report on the State of Pharmaceutical Quality is intended to help characterise the quality of the U.S. drug supply chain. Released 2nd Sept 2025.
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MHRA - August MHRA News
3rd September 2025The essential industry newsletter where we update you on our most recent activities.
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MHRA - Consultation on statutory fees: proposals on ongoing cost recovery
3rd September 2025Government response, released 2nd September 2025.
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MHRA Safety Roundup
3rd September 2025August 2025
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Consultation: Proposed TGA Annotations to ICH E6(R3)
2nd September 2025This consultation invites feedback on proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month transition period.
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MHRA launches Route B notification pilot as part of clinical trials regulations rollout
29th August 2025MHRA launches Route B notification pilot as part of clinical trials regulations rollout.
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EMA - Human Medicines Highlights - August 2025
12th August 2025The newsletter for patients, consumers and healthcare professionals
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MHRA - MHRA Seeks Stakeholder Feedback on Revised ICH M4Q(R2) Guideline
12th August 2025The MHRA is consulting on the updated ICH M4Q(R2) guideline to enhance pharmaceutical quality standards.
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MHRA Seeks Feedback on Health Institution Exemption Policy
12th August 2025The MHRA is consulting on the health institution exemption to enhance patient access to innovative medical devices.
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FDA - FDA Launches PreCheck Program to Strengthen Domestic Drug Manufacturing
11th August 2025The FDA has introduced the PreCheck programme to enhance domestic pharmaceutical manufacturing.
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FDA - Warning Letter
11th August 2025Glenmark Pharmaceuticals (India)
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MHRA - MHRA Designated as WHO-Listed Authority: A Milestone for UK Life Sciences and Global Health
11th August 2025The MHRA's new status as a WHO-Listed Authority enhances the UK's global health leadership.
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MHRA - Patients to Receive Medicines 3–6 Months Sooner Under 10-Year Health Plan
11th August 2025Press release
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MHRA Blog - FDA Warning Letters
11th August 2025Actions for licence holders following the issuing of USFDA Warning Letters.
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MHRA Blog - Summer 2025
11th August 2025Summer 2025: Updates on Regulatory Reform and Innovation
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EMA - Clinical Trials Highlights July 2025
23rd July 2025Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
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MHRA - Medicines and Medical Devices Act 2021 – Stakeholder survey - Open Call for Evidence
23rd July 2025MHRA invites feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021. This call for evidence closes at 11:59pm on 19 September 2025
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EC - Stakeholders’ Consultation on EudraLex Volume 4
8th July 2025Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22 In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of Good Manufacturing Practice (GMP) guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities.
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MHRA - Medical devices: Standardised format for the periodic safety update report
4th July 2025New guidance
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EDQM - 182nd session
3rd July 2025The European Pharmacopoeia Commission (EPC) held its 182nd session on 17 and 18 June 2025.
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ICH - ICH E20 Draft Guideline Available
3rd July 2025The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has entered public consultation stage.
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MHRA - Decentralised Manufacturing Regulations Update Webinar
3rd July 2025Video added. Watch the video recording of the Decentralised Manufacturing Regulations Update Webinar, which took place on Tuesday 17 June 2025
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MHRA - Decentralised Manufacturing Regulations Update Webinar
3rd July 2025Video added. Watch the video recording of the Decentralised Manufacturing Regulations Update Webinar, which took place on Tuesday 17 June 2025
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HRA Blog - Information governance in research
1st July 2025Blog post by Matthew Sanderson, Research Regulation Specialist
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MHRA - AI Airlock, CERSIs and a new global AI network for health regulators
1st July 2025Med Tech Regs blog, June 2025: A focus on Software and AI.
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NHS HRA - New CT Guideline and Survey
1st July 2025Comments Deadline: 10th September 2025
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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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