Company News
RQA 2025 International QA Conference
We had a brilliant couple of days in Belfast for the Research Quality Association (RQA) 2025 International QA Conference!
From inspiring talks and lively discussions to reconnecting with friends and meeting new faces, the conference was full of energy, insight, and great conversation. It’s always a pleasure to be part of an event that brings the QA community together to share knowledge, challenges, and ideas.
Regulatory News
EMA issues guidance on end-of-year submission dates for type I variations in 2025
On 2nd October, the EMA announced its year-end deadlines for type I variation submissions. Type IA and IA(IN) variations must be submitted by 21st November 2025, while type IB or mixed IB/IA groupings should be filed by 30th November 2025 to start in 2025. The EMA warned that a high volume of submissions is expected before the new Variations Guidelines take effect on 15th January 2026, which may affect validation timelines.
EMA outlines key strategic updates at October 2025 Management Board meeting
On 2nd October, the EMA’s Management Board reviewed mid-year results, noting stable numbers of human and veterinary medicine applications and a shorter average duration for company-requested clock-stops. The Board endorsed the network’s first data strategy to improve data use and sharing across the EU regulatory system. It also agreed to expand the OPEN framework to include all medicines addressing unmet needs and advanced therapies and discussed measures to strengthen national authorities’ capacity and expertise.
MHRA reforms and AI tools cut UK clinical trial approval times
On 7th October, the UK announced that clinical trial approval times have halved, dropping from 91 to 41 days, thanks to regulatory reforms and AI‑supported tools. Parallel ethical and regulatory reviews, risk‑based assessment, and AI document checks have sped up the process while maintaining high safety standards. Further legislation in April 2026 will embed these changes and extend sponsor response times.
MHRA and FDA launch partnership to speed medical technology innovation and AI adoption
On 8th October, the UK’s MHRA and US FDA announced a partnership to accelerate safe adoption of medical technologies and AI in healthcare. Measures include guidance from the UK National Commission on AI in Healthcare, faster access for devices cleared by trusted regulators, and alignment of regulatory policies to reduce duplication and support innovation.
MHRA & NICE launch accelerated aligned pathway six months early
On 10th October, MHRA and NICE announced that pharmaceutical companies can now apply to an accelerated ‘aligned pathway’, combining licensing and value assessment so decisions are published simultaneously instead of sequentially. The pilot begins six months earlier than planned, aiming to reduce the usual 90‑day delay between marketing authorisation and guidance, thereby speeding up patient access to new medicines. A fully integrated joint scientific advice service is scheduled to launch by April 2026 to support companies via this pathway.
UK launches first products into ILAP to fast‑track transformative medicines
On 15th October, the MHRA announced that three investigational therapies, targeting rare diseases including neonatal metabolic disorder and Duchenne muscular dystrophy, have entered the newly refreshed Innovative Licensing and Access Pathway (ILAP), under its ‘Innovation Passport’ scheme to help developers access regulatory, NHS and health‑technology‑assessment support from the earliest stages.
MHRA to use AI to predict harmful drug interactions before patients are affected
On 22nd October, the MHRA announced it is leading a government-backed initiative to harness artificial intelligence and anonymised NHS data to identify side effects arising from combinations of medicines before they reach patients. The pilot, funded by £859,650 from the UK Government’s Regulatory Innovation Office, will focus initially on cardiovascular drugs and analyse patterns of real-world use together with lab-based human-model testing.
UK government cuts red tape to accelerate tech innovation in public services
On 22nd October, the UK’s Regulatory Innovation Office announced £8.9 million in funding for 16 pioneering projects designed to remove regulatory barriers and speed up the rollout of new technologies across public services. The initiatives include AI tools for assessing building fire-risk, autonomous street-cleaning robots, and drones delivering medicines to remote communities, supporting the government’s ambition to modernise regulation and boost innovation in sectors such as AI, digital health and engineering biology.
Professor Tony Lawler becomes Chair of ICMRA
On 23rd October, Professor Tony Lawler became Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA). He leads Australia’s Therapeutic Goods Administration (TGA) and brings nearly 30 years of experience as a physician, health administrator, and senior public servant, including roles as Tasmanian and Commonwealth Chief Medical Officer. He also holds professorial positions at the University of Tasmania and Australian National University.
FDA publishes checklists to help sponsors avoid submission delays
On 23rd October, the FDA released the internal filing checklists used by its Centre for Drug Evaluation and Research (CDER) to assess whether drug and biologic applications are sufficiently complete and reviewable. The aim is to enhance transparency and reduce the number of “Refuse to File” (RTF) decisions, which can delay new therapies by an average of 426 days following an RTF for a new molecular entity. The checklists are published as part of the updated MAPP 6025.4 “Good Review Practices: Refuse to File.” While they provide valuable guidance, they do not replace the FDA’s legal and scientific discretion in determining filing eligibility.
MHRA updates prescribing guidance and launches service survey for Isotretinoin treatment
On 27th October, the MHRA announced that the Commission on Human Medicines (CHM) has endorsed updated prescribing guidance for isotretinoin, including clearer advice on remote follow-up consultations, remote pregnancy testing and sexual-function monitoring. In parallel, the agency asks that all NHS and private dermatology services prescribing isotretinoin for acne complete a baseline survey by 16th November 2025. The data will inform future risk-minimisation measures and help monitor adherence to safety requirements while maintaining access to treatment across age groups.
MHRA blog highlights six‑month countdown to new UK clinical trials regulations
On 28th October, the MHRA Inspectorate blog highlighted that new UK clinical trials regulations will take effect on 28th April 2026, representing the most significant reform in twenty years. The post outlines that the updates will implement the ICH‑GCP E6(R3) guideline, simplify approval processes, and strengthen patient safety, transparency, and diversity in trial design. It urges researchers and sponsors to begin preparing by reviewing and updating their policies, procedures, and systems.
FDA unveils major reform to speed up biosimilars and cut drug costs
On 29th October, the FDA announced a new draft guidance designed to streamline the development of biosimilar medicines by reducing the need for broad comparative human clinical trials in certain cases. The agency also plans to make it easier for biosimilars to gain “interchangeable” status with brand‐name biologics, enhancing uptake and enabling more cost‐effective substitution at the pharmacy level. The move is aimed at boosting competition, expanding access to affordable therapies and reducing the financial burden of biologics for patients and the healthcare system.
MHRA Issues October 2025 Safety Roundup
On 28th October, the MHRA published its monthly safety update, summarising the latest guidance and alerts for users of medicines and medical devices.
MHRA signals major overhaul of rare-disease therapy regulation in UK
On 2nd November, the MHRA announced plans to overhaul how rare-disease therapies are regulated in the UK, aiming to speed access for patients with limited treatment options. Proposals include a single authorisation covering both clinical trials and marketing approval, greater use of real-world evidence, and international collaboration to support innovative gene and mRNA therapies. A draft framework is due in Spring 2026.
Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 16th October: AI Airlock Phase 2 Cohort. The MHRA published information on the AI Airlock Phase 2 Cohort, a UK regulatory sandbox programme for AI-based medical devices. The initiative introduces seven new technologies to be tested across simulated, research, and real-world environments. It addresses key regulatory challenges such as intended-use validation, AI diagnostics, and post-market surveillance, helping developers generate evidence in close collaboration with regulators. This phase runs until March 2026.
- 16th October: AI Airlock Simulation Workshops. Details were released on the MHRA AI Airlock Simulation Workshops, a series of sessions examining key regulatory challenges in the use of AI as a Medical Device. The workshops addressed topics including explainability, hallucination evaluation, and post-market surveillance and continuous monitoring. Bringing together experts from industry, healthcare, and regulation, they produced insights and recommendations to help shape future regulatory approaches.
US Food & Drug Administration (FDA)
- 27h October: Quality Management System Information for Certain Premarket Submission Reviews. Outlines how medical device manufacturers should align their Quality Management Systems (QMS) with regulatory requirements and ISO 13485:2016 standards when preparing certain premarket submissions
- 28th October: Menstrual Products – Performance Testing and Labelling Recommendations. This guidance document from the FDA provides recommendations for performance testing, labelling, and submission information for certain menstrual products (such as tampons, pads and menstrual cups) when being submitted for pre‑market review.
- 29th October: Scientific Considerations in Demonstrating Bio similarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. Provides updated recommendations for industry on when comparative clinical efficacy studies may or may not be required to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.
European Medicines Agency (EMA)
- 3rd November: Onboarding of users to Substance, Product, Organisation. This document describes the process for organisations, including industry and national competent authorities, to register for and access SPOR master data services for Substances, Products, Organisations, and Referentials (SPORs). It covers user roles, registration through the EMA Account Management portal, and how users are linked to their organisation in the Organisation Management Service. Additionally, it provides information on access levels, permission structures, registration prerequisites, training requirements, and technical access methods, including both API and user interface options.
European Commission
- 30th October: New and updated documents – EudraLex Volume 10: Clinical trials guidelines. the European Commission published new and updated documents for EudraLex Volume 10 (Clinical Trials Guidelines). The updates support the implementation of Regulation (EU) No 536/2014, providing revised guidance on Q&A, transparency rules, and documentation templates. These changes aim to improve clarity and consistency for sponsors, investigators, and regulators across EU-wide clinical trials.
Updated Guidance
MHRA
- 1st October: Clinical trials for medicines: apply for approval in the UK. Updated to clarify application validation timelines, approval processes for xenogenic ATMPs, sponsor-driven timelines, the appeals process, and requirements for simplified IMPDs, with figures now including version numbers and dates.
- 1st October: Clinical trials regulations: transitional arrangements. The guidance has been updated to include version numbers and dates in all relevant figures, and the summary table’s Labelling section was edited for accuracy, changing the description from “labelled” to “manufactured.”
- 1st October: Clinical trials for medicines: ending a clinical trial. Major updates, with revised diagrams and attachments to improve clarity around notification, results publication, and lapse procedures for ending clinical trials in the UK.
- 2nd October: Medicines marketing authorisation: change of ownership. Amended to reflect a revised “change of ownership” application form, allowing applicants to use the new form when submitting such transfers.
- 16thOctober: Innovative Licensing and Access Pathway (ILAP). The MHRA published the latest performance metrics and Innovation Passport list. The update reports 16 eligible applications, 3 passports awarded, and 100% of outcomes delivered within expected timeframes, marking the first public snapshot of ILAP’s performance.
- 16th October: Variations to marketing authorisations (MAs). The update clarifies that from 1st January 2025, UK-wide MAs for Great Britain follow the UK system, while EU authorisations will no longer be valid in Northern Ireland, and pending variations will follow the new GB procedures.
- 17th October: Clinical investigations for medical devices. A link has been added to the guidance on combined medicine and device trials (i.e., joint CTIMP + device investigations) under the section “Combined review of a CTIMP and medical device.”
- 17th October: Borderline products: how to tell if your product is a medicine. Amended to update the ‘Medicines Borderline Advice Form’, allowing applicants to use the revised form when seeking MHRA advice on whether their product is classified as a medicine.
- 29th October: The Innovative Devices Access Pathway (IDAP). The attachment “The IDAP Unmet Clinical Need Authorisation (UCNA)” was updated to reflect an extended expiry date for HistoSonics Inc’s EDISON™ System and Accessories, now valid until 30 April 2026.
- 3rd November: Regulatory considerations for therapeutic use of bacteriophages in the UK. Updated to include a reference to the draft European Medicines Agency (EMA) guidance on “Quality aspects of phage therapy medicinal products (EMA/CHMP/BWP/1/2024)”, which was released for consultation in October 2025.
- 5th November: RegulatoryConnect. The RegulatoryConnect programme has been confirmed as closing, with the portal scheduled to be wound down over the coming months as the MHRA develops a new technological platform to support its broader strategic objectives.
- 5th November: Clinical trials for medicines: modifying a clinical trial approval. A sentence has been added in the “Applying for approval of a substantial modification” section to clarify that the ethics committee does not provide automatic approval for Route B substantial modifications.
FDA
- 14th October: Dual Labelling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication. This final guidance document from the FDA’s Center for Veterinary Medicine provides recommendations on dual labelling for new animal drugs that have both fully approved and conditionally approved indications, specifically for products addressing New World screwworm. It outlines how sponsors can include both types of approval on a single label and provides direction on regulatory expectations for submission, adverse event reporting, and compliance.
- 14th October: Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukaemias. Outlines the technical specifications for submitting clinical trial data sets that include response assessments for therapies targeting acute leukaemias.
- 22nd October: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. Q&A overview on the use of investigational drugs through expanded access programs, explaining how patients with serious or life‑threatening conditions can receive unapproved therapies outside of clinical trials under specific regulatory conditions.
- 22nd October: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. Recommendations on how sponsors and developers can select, modify, or develop clinical outcome assessments (COAs) that are fit‑for‑purpose, meaning they are appropriately designed and validated to measure what matters to patients in a given clinical context.
Industry News
Hikma and Celltrion expand biosimilar access in MENA
On 6th October, Hikma Pharmaceuticals announced exclusive agreements with Celltrion to commercialise six biosimilars across the Middle East and North Africa (MENA). Hikma will market the treatments, while Celltrion handles development and supply. The biosimilars cover areas including oncology, immune diseases, and ophthalmology, aiming to provide affordable alternatives to complex biologics.
UK introduces first new UTI antibiotic in nearly 30 years but warns the fight against superbugs is far from over
On 13th October, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Gepotidacin (Blujepa) — the UK’s first new antibiotic for uncomplicated urinary‑tract infections in nearly 30 years. While this marks an important advance, experts emphasise that tackling antimicrobial resistance will require ongoing efforts in surveillance, antibiotic stewardship and development of further treatments.
Kainos secures NHS England contract to boost digital preventative healthcare
On 14th October, Kainos won a contract with NHS England’s Digital Prevention Service Portfolio to expand digital health checks, screenings, vaccinations, and self‑care tools via the NHS App. The initiative supports personalised prevention, improved vaccination uptake, and NHS England’s shift from reactive to proactive care.
100 years of biological standards safeguard medicines globally
On 14th October, the MHRA marked the centenary of the first biological standard, a benchmark that ensures medicines and vaccines are consistent, safe and effective worldwide. Today, MHRA develops over 450 biological standards and supplies more than 110,000 vials or ampoules yearly to organisations in 81 countries, underpinning global pharmaceutical quality.
NIHR invests £157 million in applied research collaborations to transform health and care
On 15th October, the National Institute for Health and Care Research (NIHR) announced £157 million funding for ten new Applied Research Collaborations (ARCs) to support research that improves health, public health, and social care across England. The ARCs will translate research into practice, evaluate new treatments, and help reduce health inequalities.
Professor James Levine argues that regulation itself can become medicine
On 16th October, the MHRA published a guest blog by Professor James Levine arguing that regulatory policy, when designed smartly, can act as a life‑saving innovation tool. He uses the UK’s Innovative Licensing and Access Pathway (ILAP) as a key example of how rules can accelerate access to new therapies, cut delays and turn regulation from barrier into enabler
EMA confirms suspension of Oxbryta for sickle-cell disease
On 17th October, the EMA’s human medicines committee (CHMP) confirmed the suspension of Oxbryta for sickle-cell disease. The review found higher death rates and more vaso-occlusive crises in treated patients compared with placebo, with no patient group showing a positive benefit–risk balance. Oxbryta will remain unavailable in the EU pending a final European Commission decision.
Widespread adoption of cell and gene therapies could unlock billions for the UK economy
On 20th October, the Cell and Gene Therapy Catapult (CGT Catapult) and the Office of Health Economics reported that adopting advanced cell and gene therapies for conditions like ALL, AML, beta‑thalassaemia, and Alzheimer’s could generate tens of billions in health, care, and economic benefits for the UK.
MHRA dismantles illicit weight‑loss jab factory in record seizure
On 24th October, MHRA announced that officers from the Criminal Enforcement Unit (CEU) raided and shut down a warehouse in Northampton, seizing tens of thousands of empty pens, raw chemical ingredients and over 2,000 unlicensed weight‑loss injections, in what is believed to be the largest single seizure of trafficked weight‑loss medicines ever recorded globally.
Qureight’s Vascul8 model validated for pulmonary vascular disorders
On 27th October, Qureight announced that its Vascul8™ model was validated in a peer‑reviewed study for predicting high-risk patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) after surgery. The model uses routine CT scans to analyse pulmonary blood-vessel volume, offering a non-invasive alternative to right heart catheterisation. Qureight says this advance supports more personalised care and smarter clinical-trial endpoints for vascular conditions.
MHRA confirms paracetamol use during pregnancy is safe
On 31st October, the FDA announced enforcement against companies marketing unapproved ingestible fluoride products for children under 3 or at low/moderate cavity risk. The agency highlighted safety concerns, potential gut microbiome effects, and limited benefits while issuing guidance to healthcare professionals and supporting research for a national oral‑health strategy.
HHS backs major update as FDA removes warnings from menopause hormone therapy
On 10th November, the U.S. Department of Health & Human Services (HHS) supported the FDA’s update of hormone replacement therapy (HRT) labels for menopausal symptoms, removing warnings about cardiovascular disease, breast cancer, and dementia while retaining guidance on endometrial cancer where relevant. The change aims to correct outdated risk messaging and promote personalised treatment decisions for women experiencing menopause.
MHRA-led study finds major inconsistencies in global microbiome research
On 11th November, the MHRA announced that, in collaboration with the Department for Education, it has embedded medicine safety education into the statutory Relationships, Sex and Health Education (RSHE) curriculum for schools in England. This initiative, launched on World Patient Safety Day, introduces students to the importance of reporting side effects through the Yellow Card scheme. The curriculum now includes guidance on recognising side effects, understanding their significance, and submitting reports via the Yellow Card website. This move empowers the next generation to actively contribute to the safety of medicines and medical devices.
EMA launches open call for committee and board members
On 11th November, the European Commission opened applications for governance roles at the EMA. Civil‑society representatives, including patients’ associations and health professionals, are invited to join the Paediatric Committee (PDCO) for a three‑year term starting 1 August 2026. Other positions across EMA scientific committees and its Management Board are also open. Applicants must submit an application form, a declaration of interests, and supporting documents as specified.
Quality ASAP: Building Fit-for-Purpose Systems in a Pragmatic World
Our latest article, published in the RQA’s QUASAR, explores Quality ASAP – Agile, Simple, Accurate, Pragmatic – a modern approach to building regulatory quality systems that truly work in practice. Traditional quality frameworks often become over-engineered, rigid, and disconnected from the realities of day-to-day operations, creating unnecessary complexity and slowing progress.
Quality ASAP focuses on designing fit-for-purpose, scalable, and people-centred systems that evolve with the organisation. By emphasising clarity, usability, and flexibility, it transforms quality from a perceived burden into a tool that drives operational efficiency, supports compliance, and empowers teams to deliver safe, effective, and innovative outcomes.
Issue Number: WN00203
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