Company News
We had a brilliant couple of days in London for the International QA Conference 2026!
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
MHRA Supports Move Away from Animal Testing
On 1st October, the Medicines & Healthcare products Regulatory Agency (MHRA) joined international medicines regulators in calling for scientifically validated alternatives to animal testing throughout the development and lifecycle of human medicines. The joint statement, developed by the International Coalition of Medicines Regulatory Authorities (ICMRA), encourages the use of non-animal testing methods, including for batch release. The aim is to support scientific innovation while maintaining high standards of medicine quality and patient safety.
EMA Confirms End-of-Year Submission Deadlines
On 1st October, the European Medicines Agency (EMA) reminded marketing authorisation holders of the submission deadlines for Type I variations ahead of the end of 2026. Type IA annual updates, individual Type IA and IAIN variations, and super-groupings should be submitted by 20th November, while Type IB variations and relevant groupings are due by 30th November. Submissions received after these dates may not be processed until January 2027.
UK Government Backs AI Regulation Recommendations
On 6th October, the UK Government announced it would accept all 44 recommendations from the National Commission into the Regulation of AI in Healthcare. The recommendations focus on strengthening regulatory oversight, improving transparency and ensuring continuous monitoring of AI-enabled medical devices to protect patients. The announcement also confirmed the launch of Phase 3 of the MHRA’s AI Airlock, which will focus on post-market surveillance and monitoring devices throughout their lifecycle.
EMA Makes Clinical Trial Application Advice Pilot Permanent
On 8th October, the EMA announced that its Accelerating Clinical Trials in the EU (ACT EU) clinical trial application advice pilot will become a permanent initiative from January 2027. The service provides sponsors with coordinated technical and regulatory advice from participating Member States before applications are submitted through the Clinical Trials Information System (CTIS). The initiative aims to improve application quality, strengthen regulatory cooperation and support more efficient assessment processes.
MHRA Chair Outlines Five-Year Strategy Priorities
On 9th October, MHRA Chair Professor Anthony Harnden outlined the priorities shaping the Agency’s five-year strategy, following feedback from experts across academia, industry and healthcare. Key areas include strengthening collaboration across the UK, supporting safe innovation through proportionate regulation and improving patient safety surveillance. The Agency also highlighted the importance of transparency, public trust and continued investment in staff skills and expertise.
MHRA Launches 2030 Strategy
On 13th October, the MHRA published its five-year 2030 Strategy, setting out plans to modernise healthcare regulation in response to advances in AI, personalised medicines and medical technologies. Priorities include improving patient safety through real-time data monitoring, accelerating access to innovative treatments and strengthening clinical research. The strategy also aims to increase patient involvement, support alternatives to animal testing and position the UK as a global leader in life
FDA Develops New Framework for Rare Disease Medicines
On 14th October, the US Food and Drug Administration (FDA) launched its Rare Disease Framework Initiative to develop a more tailored approach to the development and regulatory review of treatments for rare diseases. The initiative will explore challenges associated with small patient populations and limited clinical evidence, including the use of innovative clinical trial designs and earlier patient involvement. It will also consider more flexible, risk-based approaches to manufacturing quality and inspections while maintaining standards for safety and effectiveness.
MHRA Outlines AI and MedTech Regulatory Plans
On 19th October, the MHRA outlined its plans to modernise UK regulation of AI and medical technologies at the AdvaMed 2026 conference in the US. Proposals include developing a more flexible, lifecycle-based framework for AI-enabled medical devices, expanding the AI Airlock regulatory sandbox and establishing a new Centre for AI and Digital Health. The Agency also highlighted plans to strengthen collaboration with the US FDA and improve medical device data and traceability while supporting innovation and patient safety.
FDA Launches Neuroscience Innovation Programme
On 22nd October, the FDA launched its Neuroscience Advancement and Innovation Nexus (NAIN), a programme designed to accelerate the development of medicines, biologics and medical devices for conditions affecting the brain and nervous system. The initiative will bring together regulatory expertise and engage patients, researchers and industry to address challenges involving clinical trial design, biomarkers and evidence of clinical benefit. Its first initiative, the Alzheimer’s Prevention Accelerator, will focus on products designed to delay or prevent Alzheimer’s disease.
EMA and African Medicines Agency Publish Ebola Vaccine Guidance
On 23rd October, the EMA and African Medicines Agency (AMA) published joint guidance to accelerate the clinical development of vaccines against Bundibugyo virus, a strain of Ebola. The guidance outlines requirements for starting clinical trials, recommendations for trial design and circumstances where certain preclinical toxicity studies may be postponed or waived for well-characterised vaccine platforms. It also encourages early engagement with African regulators and the use of adaptive trial approaches to evaluate multiple vaccine candidates.
MHRA Publishes October Safety Roundup
On 27th October, the MHRA published its October safety roundup, highlighting recent alerts and important safety updates relating to medicines and medical devices. The roundup includes information on identified risks, product recalls and recommended actions for healthcare professionals. It aims to support awareness of emerging safety concerns and help protect patients.
MHRA and HRA Publish Clinical Trial Diversity Findings
On 3rd November, the MHRA and Health Research Authority (HRA) published findings from a six-month pilot testing Inclusion and Diversity Plans for clinical trials and medical device investigations. The pilot found that developing these plans during the study design stage helped researchers consider how to recruit a more representative range of participants. Updated guidance has been published, with a further 12-month implementation phase planned for early 2027 to encourage wider participation in clinical research.
MHRA and NICE Continue Real-World Evidence Programme
On 5th November, the MHRA and National Institute for Health and Care Excellence (NICE) announced the continuation of their Real-World Evidence (RWE) Scientific Dialogue programme, providing a forum for industry and regulators to discuss study design, data sources and analytical methods. The initiative aims to improve the quality and consistency of real-world evidence used in regulatory and health technology assessment decisions. Applications for the current cycle close on 1st February 2027.
Industry News
Edwards Lifesciences Receives FDA Approval for Adjustable Paediatric Heart Valve
On 1st October, approved Edwards Lifesciences’ AUTUS Size-Adjustable Valve, the first surgical pulmonary valve designed to expand as children grow. Intended for paediatric patients with congenital heart disease requiring pulmonary valve replacement, the device can be enlarged using a balloon catheter, potentially reducing the need for repeat open-heart surgery. Approval was based on clinical data from 62 patients, with long-term follow-up studies required to monitor safety and performance over 10 years.
Bespak Partners with SNBL on Nasal Drug Delivery Technology
On 6th October, Bespak announced a collaboration with Shin Nippon Biomedical Laboratories (SNBL) to provide exclusive global access to its nasal dry powder delivery device. The single-use device uses a user-activated air pump to deliver medication without requiring patients to coordinate their breathing. It could offer benefits such as improved drug stability, bioavailability and targeted delivery, supporting the development of future intranasal therapies.
RougeTx Launches with $58 Million Funding
On 6th October, RougeTx announced its launch with $58 million in Series A funding to advance RTX-001, a potential once-daily oral treatment for hereditary haemorrhagic telangiectasia (HHT). The inherited condition causes abnormal blood vessel formation, which can lead to recurrent bleeding, chronic anaemia and potentially serious complications. RTX-001 is designed to improve blood vessel stability and could offer a disease-modifying approach for a condition with no currently approved therapies.
MHRA Approves Catumaxomab for Cancer-Related Ascites
On 7th October, the MHRA approved catumaxomab (Korjuny) for adults with malignant ascites, a build-up of cancer-containing fluid in the abdomen, when standard cancer treatments are no longer suitable. The monoclonal antibody works by helping the immune system recognise and destroy cancer cells. Clinical trial results showed that treatment extended the time before patients required further fluid drainage, providing an additional treatment option.
Northwest Biotherapeutics Partners with NHS Blood and Transplant
On 8th October, Northwest Biotherapeutics announced a collaboration with NHS Blood and Transplant (NHSBT) and Advent Bioservices to support UK production of DCVax-L, an experimental personalised cancer immunotherapy being developed for glioblastoma and other solid tumours. NHSBT will provide specialist leukapheresis services to collect patients’ immune cells, alongside cell processing and handling to support manufacturing. The collaboration initially involves facilities in Leeds and Oxford, with potential plans to expand to further locations across England.
MHRA Issues Warning on Antifungal Medicines During Renal Replacement Therapy
On 13th October, the MHRA issued a device safety alert warning that antifungal medicines such as caspofungin can bind to polyacrylonitrile (PAN)-based filters used during continuous renal replacement therapy (CRRT). This interaction could reduce treatment effectiveness by affecting the amount of medicine available to patients. Healthcare professionals are advised, where possible, to administer these medicines at least six hours after starting CRRT or following a filter circuit change.
MHRA Strengthens Antidepressant Safety Warnings
On 15th October, the MHRA announced new measures to improve how antidepressant risks are communicated to patients and healthcare professionals following a major review. Changes will include stronger warnings about suicidal thoughts and behaviours, clearer information on persistent sexual dysfunction (PSSD) and a new patient safety card. An additional safety leaflet is also being developed for release in 2027 to support informed treatment discussions.
MHRA Seizes £2 Million of Counterfeit Weight-Loss Pens
On 15th October, the MHRA and West Midlands Police seized more than 12,000 counterfeit retatrutide and tirzepatide weight-loss pens, valued at approximately £2 million, during a raid in Birmingham. Packaging for a further 30,000 products was also recovered. The MHRA warned that these unauthorised medicines have not been assessed for safety, quality or effectiveness and urged consumers to obtain weight-loss treatments only from registered pharmacies with a valid prescription.
EMA Recommends Rasonque for Metastatic Pancreatic Cancer
On 15th October, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorisation for Rasonque (daraxonrasib), an oral treatment for adults with previously treated metastatic pancreatic cancer. Phase 3 trial results involving 500 patients demonstrated improvements in overall and progression-free survival compared with chemotherapy. The medicine underwent an expedited EMA review, with the recommendation now referred to the European Commission for a final decision on EU-wide authorisation.
Sanofi Begins Construction of New Insulin Manufacturing Facility
On 19th October, Sanofi began construction of a new insulin manufacturing facility at its BioCampus in Frankfurt, Germany, as part of a long-term investment in global insulin supply. The site will incorporate advanced manufacturing technologies, automation, artificial intelligence and digital systems across production and quality processes. Once fully licensed, production of insulin active pharmaceutical ingredients is expected to begin in 2032.
MHRA Approves New Oral Treatment for Plaque Psoriasis
On 23rd October, the MHRA approved icotrokinra hydrochloride (Icotyde), a once-daily oral treatment for moderate to severe plaque psoriasis in adults and adolescents aged 12 and over who weigh at least 40kg. The treatment works by blocking the IL-23 receptor, helping to reduce inflammation associated with the condition. Approval was supported by four Phase 3 clinical trials involving approximately 2,500 participants.
Octane and Currus Automate CAR T-Cell Manufacturing
On 27th October, Octane Biotech and Currus Biologics announced the successful automation of the manufacturing process for CUR-001, an investigational CAR T-cell therapy for advanced solid tumours. The process has been transferred to Octane’s Cocoon Platform, a closed automated system designed to reduce manual handling, manufacturing variability and costs. Following FDA clearance of its Investigational New Drug application, the therapy is expected to enter a Phase 1 clinical trial, with initial patient dosing anticipated in early 2027.
Panthera Expands Glasgow Clinical Research Centre
On 27th October, Panthera officially opened its expanded Glasgow Clinical Research Centre at the Health Innovation Hub, increasing capacity for clinical trials and creating more opportunities for patients to participate in medical research. The purpose-built facility includes eight dedicated clinical rooms, laboratory facilities and modern office space. The expansion aims to strengthen Scotland’s clinical research infrastructure and improve access to investigational treatments.
MHRA Research Advances Needle-Free Strep A Vaccine
On 27th October, the MHRA published research conducted with the GSK Vaccines Institute for Global Health, demonstrating progress towards a potential vaccine against Group A Streptococcus (Strep A). Preclinical studies in mice showed that delivery through the nose or under the tongue generated immune responses both at infection sites and throughout the body. The GMMA-based approach could support affordable, needle-free vaccines and help reduce antibiotic use and antimicrobial resistance, although further research is needed before human trials.
Exogenus Leads €13 Million Osteoarthritis Research Consortium
On 29th October, Exogenus Therapeutics announced the launch of ExoCordOA, a five-year, €13 million EU-funded consortium to advance secretome-based treatments for osteoarthritis. The project brings together ten organisations, including Lonza, Anthony Nolan and Utrecht University, to support clinical development of EXO-101, an investigational biologic derived from umbilical cord blood cells. Initial Phase 1b studies are expected to begin in early 2028, with the wider project also aiming to address manufacturing, quality-control and regulatory challenges.
Teva and Samsung Bioepis Announce Biosimilar Partnership
On 3rd November, Teva and Samsung Bioepis announced a licensing and commercialisation agreement covering two FDA-approved biosimilars for inflammatory and autoimmune conditions: ETICOVO (etanercept-ykro) and infliximab-abda. Teva will obtain US commercialisation rights for ETICOVO following completion of the agreement, with rights for infliximab-abda expected to transfer in the third quarter of 2027. Samsung Bioepis will retain responsibility for manufacturing and regulatory oversight of both products.
FDA Grants Accelerated Approval to New Treatment for Head and Neck Squamous Cell Carcinoma
On 5th November, the FDA granted accelerated approval to Rybrevant Faspro for certain adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed following platinum-based chemotherapy and immunotherapy. Clinical trial results demonstrated an overall response rate of 42%, compared with approximately 20% or less for currently approved therapies. The approval is subject to confirmatory studies to verify clinical benefit and includes important safety warnings covering hypersensitivity reactions, lung and skin effects, and ocular toxicity.
Published Guidance
MHRA
- 2nd October: Electronic Application Forms (eAF) for UK medicines licensing applications. Information on how to download, complete and submit electronic forms for UK medicines licensing applications, including new marketing authorisations, variations and renewals. It covers form validation and submission requirements. It was updated on the 9th of October with clearer information.
- 6th October: AI Airlock Phase 3 application. Clarifies how developers can work with the MHRA to test AI-enabled medical devices, focusing on ongoing safety, performance monitoring and post-market surveillance. It also outlines eligibility, application requirements and three testing environments: simulation, virtual and real-world.
- 6th October: What the National Commission’s recommendations mean for you. Explains how the National Commission’s recommendations for regulating AI in healthcare could affect patients, healthcare professionals, providers and developers. It outlines changes to improve safety, transparency and accountability, while supporting responsible AI innovation across the UK healthcare system.
- 9th October: MHRA Real-World Evidence: knowledge and guidance. Provides resources explaining how real-world patient and healthcare data should be collected, analysed and used to support regulatory decisions on the safety and effectiveness of medicines and medical devices.
- 4th November: Use of non-OECD MAD non-clinical data in support of UK clinical trial authorisation applications. Describes how data generated outside the OECD Mutual Acceptance of Data framework can be used to support UK Clinical Trial Authorisation applications. It outlines the evidence, GLP assurance and additional checks required to demonstrate data reliability and integrity, while ensuring participant safety.
EMA
- 19th October: Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports. Draft guidance on improving the quality of adverse drug reaction (ADR) reports across human and veterinary medicines. The framework focuses on five key data quality areas: reliability, completeness, consistency, timeliness and relevance. It provides recommendations for improving data collection, management and submission, including stronger validation processes, staff education, feedback mechanisms and duplicate detection. The public consultation closes on 14 December 2026.
- 9th November: Guideline on risk assessment of medicinal products in human reproduction and breastfeeding: from data to product information. Draft revised guidance on assessing the risks of medicines in relation to fertility, pregnancy, foetal development and breastfeeding. It explains how non-clinical and clinical evidence should be combined to evaluate potential risks and inform recommendations for medicine use. It also provides updated advice on risk classification, risk minimisation measures and how safety information should be communicated in product information and patient leaflets. The public consultation is open until 28 February 2027.
FDA – Draft Guidances
- 8th October: Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants. A guide for implementing the standard adopted by the ICH for electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard. This Implementation Guide (IG) was jointly developed by the ICH E2B(R3) and M2 Expert Working Groups (EWGs). The ICH E2B(R3) EWG provided business requirements and the M2 EWG provided technical content for this IG. These two EWGs were reconstituted as the ICH E2B(R3) EWG in November 2010.
- 27th October: Individualised Human Genome Editing Products: Considerations for BLA Submission and Post-approval Management. explains how an individualised gene-editing (GE) product containing multiple variants can be submitted under a single Biologics License Application (BLA) in accordance with section 351(a) of the PHS Act. It outlines how to document variations between GE components and how to add new product variants following approval. It also covers related requirements, including in vitro safety and potency testing, manufacturing process validation, labelling, indications, and product naming and identification.
- 28th October: Electronic Submission Template for Investigational Device Exemption (IDE) Applications. When finalised, this draft guidance will provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.
- 29th October: Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products. Addresses key aspects of drug delivery performance information for devices and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product.
- 30th October: E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers (R1). Clarifies key issues to facilitate implementation of the ICH guidelines for industry E14 “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs” (October 2005) and S7B “Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarisation (QT Interval Prolongation) by Human Pharmaceuticals” (October 2005). The revised Q&A document includes updates to Questions 5.1, 6.1, and 6.3 for E14, as well as revised and new questions for Sections 1 and 3 of S7B.
- 2nd November: Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products. Provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product.
- 4th November: Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus. Provides recommendations for testing blood donations to reduce adequately and appropriately the risk of HBV transmission under these regulations.
Updated Guidance
MHRA
- 2nd October: Apply for a licence to market a medicine in the UK. Added a link to the new guidance page on electronic Application Forms (eAFs).
- 5th October: Good machine learning practice for medical device development. Updated the MHRA contact email address to info@mhra.gov.uk.
- 9th October: International Recognition Procedure. Added a new validation checklist form to the IRP page.
- 14th October: Good laboratory practice (GLP) for safety tests on chemicals. Updated the list of members of the UK GLP Compliance Monitoring Programme.
- 15th October: Antidepressants: use and safety. Updated the guidance to reflect the findings of the MHRA’s review of antidepressants, including how patients are informed about the risks of suicidal thoughts and behaviours, and sexual dysfunction that may persist after treatment has stopped.
- 22nd October: COVID-19 test validation approved products. Added an updated spreadsheet titled ‘Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations’.
- 27th October: Access, new active substance and biosimilar work sharing initiatives. Added Icotyde (icotrokinra) to the ‘MHRA NASWSI approvals’ table.
- 5th November: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines. Links have been updated to the following guidelines: E2D(R1), covering post-approval safety data and the management and reporting of individual case safety reports; E8(R1), covering general considerations for clinical studies; M12, covering drug interaction studies; M15, covering general principles for model-informed drug development; Q13, covering continuous manufacturing of drug substances and drug products; and E6(R3), covering Good Clinical Practice.
FDA – Final Guidances
- 1st October: Electronic product information (ePI) submission during centralised procedures. Provides additional time to update the functionality of the information technology system to enable it to accept the mail service name and tracking number for food arriving by international mail as part of the prior notice process.
- 1st October: E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide – Data Elements and Message Specification; and Appendix to the Implementation Guide – Backwards and Forwards Compatibility. Provides guidance on implementing the ICH standard for the electronic transmission of Individual Case Safety Reports (ICSRs) using the ICH E2B(R3) message format. The guide was jointly developed by the ICH E2B(R3) and M2 Expert Working Groups (EWGs), with the E2B(R3) group contributing the business requirements and the M2 group providing the technical content. Both groups were subsequently reconstituted as the ICH E2B(R3) EWG in November 2010.
- 8th October: Study Data Technical Conformance Guide – Technical Specifications Document. Outlines the FDA’s current technical specifications and recommendations for this topic.
- 9th October: Post-approval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers. Provides answers to frequently asked questions from applicants and other interested parties about post-approval manufacturing changes to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalises the draft guidance issued on 23 July 2024.
- 9th October: Questions and Answers on Biosimilar Development and the BPCI Act. Provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
- 14th October: Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy. Explains the regulatory requirements for assessing donor eligibility at establishments collecting blood and blood components for transfusion or further manufacturing use, including Source Plasma.
- 14th October: Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements. Addresses specific regulatory requirements for blood establishments collecting blood and blood components, including Source Plasma. The guidance outlines the circumstances in which the FDA does not intend to take regulatory action where establishments fail to meet certain requirements relating to donation suitability (21 CFR 630.30), donor eligibility (21 CFR 630.10(c)(2)) and Source Plasma quarantine holds (21 CFR 640.69(f)).
- 19th October: Guidance for Industry: New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI. Provides recommendations for manufacturers and distributors of new dietary ingredients (NDIs), and dietary supplements containing NDIs, on the information that should be included in a New Dietary Ingredient Notification (NDIN).
- 19th October: Safety Reporting Requirements for INDs and BA/BE Studies. Aims to help small businesses understand and comply with the FDA’s expedited safety reporting requirements for human drugs and biological products investigated under an Investigational New Drug (IND) application, or as part of a bioavailability (BA) or bioequivalence (BE) study exempt from IND requirements.
- 20th October: Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle. Sets out the technical specifications for submitting clinical trial data from studies evaluating the ability to operate a motor vehicle (driving studies) in support of marketing applications for drug and biological products.
- 20th October: Regulatory Considerations for Prescription Drug Use-Related Software. Explains how the FDA applies its drug labelling authorities to certain software outputs distributed by, or on behalf of, a drug sponsor for use with prescription medicines or prescription drug-led combination products. This includes products assigned to the Centre for Drug Evaluation and Research (CDER) or the Centre for Biologics Evaluation and Research (CBER) as the lead centre.
Quality That Makes a Difference: Celebrating 25 Years of Tower Mains
On 30th October, Tower Mains celebrated its 25th anniversary, marking 25 years since Andrew Waddell and Fiona Waddell took a leap into the unknown to establish a consultancy with a clear vision and a belief that quality assurance should make a meaningful difference.
Twenty-five years on, Tower Mains continues to grow and evolve, while remaining true to the values and principles on which it was founded. This milestone provides an opportunity to reflect on the people, expertise and valued relationships that have shaped the company and its journey.
We would like to thank everyone who has been part of our story over the past 25 years. Here’s to celebrating our achievements and looking forward to the next chapter!
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