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About us
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CTIS Change Management Survey
4th December 2025Extended deadline 16 January 2026
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Centres of Excellence for Regulatory Science and Innovation (CERSIs)
4th December 2025The MHRA has launched a UK-wide network of Centres of Excellence to advance regulatory science and bring innovative treatments to patients sooner.
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Get regulatory advice from MHRA — Medical Devices
4th December 2025MHRA offers formal “regulatory advice” to help device developers and manufacturers understand how UK medical-device regulations apply to their products.
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Landmark UK–US pharmaceuticals deal to safeguard medicines access and drive vital investment for UK patients and businesses
4th December 2025The UK and US have struck a new trade agreement that removes tariffs on UK medicines exports to the US, aiming to boost investment and improve access to new treatments.
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EDQM issues draft revised guideline on revision/renewal of CEPs for public consultation
2nd December 2025The EDQM has released a draft update to its guideline on revising and renewing Certificates of Suitability (CEPs) to the European Pharmacopoeia (Ph. Eur.) — and is now inviting public consultation.
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EMA Human Medicines Highlights
2nd December 2025November 2025 Edition out now
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FDA Drafts Guidance on Where to Submit Cross-Center Master Files
2nd December 2025The U.S. Food and Drug Administration (FDA) has issued draft recommendations clarifying which centre should host “cross-centre” Master Files (MFs) when they support multiple product types.
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FDA Issues New Guidance on CGMP for Medical Gases
2nd December 2025The Food and Drug Administration (FDA) has published a draft guidance to support the implementation of updated manufacturing rules for medical gases.
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FDA expands artificial-intelligence capabilities with “agentic” AI deployment
2nd December 2025The U.S. Food and Drug Administration (FDA) has rolled out “agentic AI” to support staff across the agency — marking a major step in its internal AI rollout.
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ICH Assembly Meeting, Singapore — November 2025
2nd December 2025The International Council for Harmonisation (ICH) held its 2025 Assembly in Singapore, completing major guideline decisions and welcoming new members.
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International Council for Harmonisation (ICH) Assembly Welcomes New Members and Observers
2nd December 2025ICH expands its global regulatory network by admitting new members and observers during its November 2025 meeting.
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Meeting Highlights – European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 24–27 November 2025
2nd December 2025The EMA’s PRAC met 24–27 November to review safety-related issues for authorised medicines — concluding no new referral procedures, but continuing ongoing assessments and routine pharmacovigilance tasks.
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New MHRA-supported research reveals patterns of vaccine-derived poliovirus spread
2nd December 2025A major study offers new insight into how vaccine-derived poliovirus type 2 spreads and what this means for global eradication.
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Innovative approaches to Med Tech regulatory reform
28th November 2025The MHRA sets out new steps to modernise the UK’s medical technology regulatory framework.
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Insurance Review in Phase 1 Clinical Trials
28th November 2025The MHRA Inspectorate clarifies updated insurance requirements for Phase 1 clinical trials ahead of the 2026 regulations.
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MHRA Strategy Blog Series
20th November 2025The MHRA has launched a strategy blog series bringing together external voices to discuss the future direction of UK medicines and medical devices regulation.
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Professor Alastair Denniston: The future regulation of AI in healthcare
20th November 2025Professor Alastair Denniston sets out core principles for a new UK framework to regulate AI in healthcare so it is safe, fast and trusted.
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EMA CHMP Meeting Highlights – 10-13 November 2025
19th November 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten new medicines for approval and four extensions of indication at its November 2025 session.
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EMA Improves Scientific Advice for Medicines Addressing Public Health Threats —including Antimicrobial Resistance
19th November 2025The European Medicines Agency (EMA) has enhanced its scientific advice services to better support the development of medicines tackling public-health threats like antimicrobial resistance.
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Multi-million-pound backing for cutting-edge projects by UK scientists and innovators
19th November 2025The UK government has announced substantial funding to accelerate scientific breakthroughs and innovation across key sectors.
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Quality Management System Information for Certain Premarket Submission Reviews
19th November 2025The Food and Drug Administration (FDA) has issued draft guidance outlining new expectations for Quality Management System (QMS) documentation in device pre-market submissions.
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The Importance of Accurate GTIN and 2D Barcode Data in the Modern Healthcare Environment
19th November 2025A new blog post by the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate highlights how precise Global Trade Item Number (GTIN) and 2D barcode information are critical to patient safety and supply-chain integrity.
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EMA partners with healthcare professionals & consumers for #ItTakesATeam medicine shortages campaign
13th November 2025The European Medicines Agency (EMA) has launched the #ItTakesATeam awareness campaign to emphasise that tackling medicine shortages in the EU requires collaboration among patients, professionals, and regulators
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MHRA-led study finds major inconsistencies in global microbiome research
13th November 2025New international benchmarks aim to make gut microbiome studies more reliable for diagnosis and treatment.
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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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