Celebrating 25 Years of Quality, Continuity and Trust
This year marks a major milestone for Tower Mains as we celebrate 25 years of supporting the global scientific community.
From the outset, our approach has been shaped by what customers told us mattered most: access to trusted, end-to-end quality support, and the confidence that comes from continuity and predictability. In response, we established two core principles that continue to define Tower Mains today. First, we built an experienced, multi-disciplinary team capable of delivering audits, training, and consultancy across the full spectrum of regulatory and academic work. Second, our services are delivered by our own employees, ensuring continuity, availability, and a consistently high standard of service.
While much has changed over the last 25 years – from evolving regulations to advances in technology – these founding principles remain unchanged and continue to guide us into the future.
Keep an eye out throughout the year as we share anniversary updates, reflections, and highlights from our journey so far.
Regulatory News
MHRA and Northern Ireland strengthen regulatory collaboration
On 9th December, the Medicines and Healthcare products Regulatory Agency (MHRA) and partners across Northern Ireland led by the Department of Health agreed to deepen their partnership to support innovation, improve patient safety, and ensure continued access to high-quality regulation of medicines and medical technologies. The agreement includes boosting the Yellow Card reporting scheme, increasing participation in research, and establishing an MHRA presence in Northern Ireland to strengthen engagement with local healthcare and life sciences stakeholders.
FDA Approves First Drug Under National Priority Voucher Pilot to Bolster U.S. Antibiotic Supply
On 9th December, the US Food & Drug Administration (FDA) granted the first approval under its new Commissioner’s National Priority Voucher (CNPV) pilot program – Augmentin XR, a domestically manufactured oral antibiotic – in just two months, a major acceleration versus typical review timelines. The move aims to strengthen US drug supply chains, address longstanding antibiotic shortages and support national health priorities by enabling faster access to essential medicines.
MHRA Chair Welcomes Re-Appointment of Three Non-Executive Directors
On 11th December, MHRA Chair Professor Anthony Harnden welcomed the re-appointment of three non-executive directors – Mercy Jeyasingham, Dr Junaid Bajwa and Rajakumari Long – whose continued insight and leadership will support the agency’s strategic work and its mission to protect and improve public health across the UK.
ICH Outlines New ATMP Guideline Roadmap for Global Harmonisation
On 11th December, the International Council for Harmonisation (ICH) published recommendations from its Cell & Gene Therapy Discussion Group, setting a roadmap for future advanced therapy medicinal product (ATMP) guidelines. The aim is to harmonise global regulation of cell and gene therapies by prioritising new guidance and updates to existing standards across the product lifecycle.
UK–Singapore Corridor Set to Fast-Track Breakthrough Health Technology
On 12th December, the MHRA and Singapore’s Health Sciences Authority launched a first-of-its-kind regulatory innovation corridor designed to speed up access to breakthrough health technologies. The new coordinated pathway lets companies engage with both regulators simultaneously for early joint advice, helping to reduce duplication and delays while maintaining safety. This initiative aims to accelerate patient access to transformative therapies in areas such as cancer, neurodegenerative diseases, rare diseases, and advanced diagnostics, and to strengthen both countries as global hubs for life sciences innovation.
UK enhances trial regulation to attract global research
On 13th December, the MHRA announced a new package of reforms designed to make the UK a more attractive destination for clinical research and help patients access new treatments sooner. The changes include faster assessment routes for lower-risk studies and a 14-day review for phase 1 trials, alongside more agile regulatory approaches that support innovation—such as using early overseas safety data and simulation models. The MHRA said the reforms will reduce delays, speed up trial start-up times and strengthen the UK’s position as a global hub for life sciences while maintaining safety standards..
EU Publishes 2024 Annual Report on Paediatric Medicines Regulation
On 15th December, the European Commission released the 2024 annual report on the Paediatric Medicines Regulation, outlining how the EU’s framework has supported the development and availability of medicines for children. The report includes data on incentives, compliance with paediatric investigation plans, and the impact of regulatory rewards and penalties on companies and products across the EU.
MHRA Welcomes Professor Jonathan Benger CBE as New NICE CEO
On 15th December, the MHRA congratulated Professor Jonathan Benger CBE on his appointment as Chief Executive Officer of the National Institute for Health and Care Excellence (NICE). His leadership comes at a pivotal time as the two organisations work more closely to streamline access to innovative medicines and technologies.
European Commission Backs Health Innovation and Biotech Growth
On 16th December, the European Commission proposed a package of measures to strengthen the EU health sector, including a Biotech Act, reforms to medical device rules, and a Safe Hearts Plan to tackle cardiovascular disease. It aims to accelerate innovation, reduce costs, and improve patient care across Europe.
UK government consults on AI healthcare regulation
On 18th December, the MHRA launched a Call for Evidence inviting patients, clinicians, industry, and the public to share views on how artificial intelligence in healthcare should be regulated, helping to shape future safeguards and standards through the National Commission into the Regulation of AI in Healthcare and inform MHRA recommendations in 2026.
EMA’s Emer Cooke Highlights 2025 as Landmark Year for EU Medicines Regulation
On 19th December, the European Medicines Agency (EMA) Executive Director Emer Cooke highlighted key 2025 achievements, including a landmark agreement on new EU pharmaceutical legislation, recommendations for 104 new human medicines and a record 30 veterinary medicines, and major steps on shortages monitoring and clinical trial transparency. She also signalled continued focus on digitalisation, AI, and regulatory capacity building for the European medicines network.
MHRA Appoints New Chief Medical & Scientific Officer
On 5th January, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that Professor Jacob George has started in the newly created role of Chief Medical and Scientific Officer (CMSO), where he will lead the agency’s science strategy and oversee its scientific, research and innovation activities, reflecting a commitment to scientific excellence and strengthening the UK’s life sciences and public health regulation.
UK Eyes Next-Gen Pharmacovigilance to Boost Drug Safety Monitoring
On 8th January, Professor Sir Aziz Sheikh outlined plans in an MHRA strategy blog for moving the UK’s pharmacovigilance system from largely passive reporting to a next-generation, data-driven model that leverages near-universal digitised health records, linked datasets and advanced analytics, including AI, to detect adverse drug events faster and more proactively across the whole population, enhancing patient safety and real-world surveillance capabilities.
MHRA Strengthens Addiction Warnings on Common Medicines
On 8th January, MHRA announced enhanced safety warnings for medicines used to treat pain, anxiety, and insomnia, including gabapentinoids, benzodiazepines and z-drugs. The updates highlight risks of addiction, dependence and withdrawal, provide clearer guidance on safer use and stopping treatment, and advise caution when combined with opioids or alcohol.
FDA Boosts Flexibility for Cell and Gene Therapy Regulation to Spur Innovation
On 11th January, the FDA announced a more flexible approach to chemistry, manufacturing and control (CMC) requirements for cell and gene therapies, tailoring oversight to the unique complexities of these advanced biologics to help expedite development and support innovation. The agency clarified flexibilities that can be applied throughout development and in preparation for Biologics License Application (BLA) submissions, while continuing to uphold standards for safety, purity, and potency.
UK Reforms Aim to Get Patients Treatment Sooner with Faster Clinical Trial Approvals
On 13th January, the MHRA unveiled a package of reforms to make the country more attractive for clinical research by speeding up assessments and introducing agile regulatory routes. New data show a rise in clinical trial activity in 2025, and under upcoming regulations, lower-risk studies will benefit from fast-track notification routes and 14-day phase 1 reviews, helping get trials up and running sooner while maintaining safety.
EMA & FDA Agree on Joint AI Principles to Guide Medicine Development
On 14th January, EMA and the FDA announced a jointly developed set of 10 common principles for good artificial intelligence (AI) practice across the medicines lifecycle, from early research and clinical testing to manufacturing and safety monitoring, designed to promote safe, ethical and harmonised AI use that supports innovation while protecting patients.
EMA Reports Strong Human Medicines Output in 2025
On 15th January, the EMA published its “Human medicines in 2025” overview, showing that its human medicines committee recommended 104 medicines for marketing authorisation in the EU last year, including 38 with completely new active substances and many treatments addressing unmet needs such as rare diseases, diabetes, and respiratory conditions. The report also highlighted numerous biosimilar recommendations that support access and affordability and noted ongoing safety monitoring once medicines are authorised.
ICH Issues Updated Technical Documents for Three Key Guidelines
On 15th January, the ICH announced that expert working groups have published updated technical documents to support three guidelines under development: E2B(R3) on individual case safety reports, M4Q(R2) on the Common Technical Document quality section, and E6(R3) Good Clinical Practice, including implementation guides, mapping materials and new training modules to help regulators and industry apply the draft and evolving standards.
Published Guidance
MHRA
- 15th December: In Vitro Diagnostic roadmap. This roadmap outlines deliverables and timelines to support the development and access of innovative IVD devices, which play a critical role in improving patient outcomes through timely diagnosis and effective treatment.
- 17th December: Health Institution Exemption for general medical devices. Guidance on the Health Institution Exemption (HIE) for general medical devices, replacing prior “in-house manufacture” guidance and clarifying when and how health institutions, such as NHS trusts and hospitals, can design, make or modify medical devices for use within their own premises without full UKCA conformity assessment, provided specific conditions and leading practice guidelines are met.
- 12th January: Clinical Trials Regulations enforcement provisions. Explains how and when infringement notices or offences can be issued to sponsors, investigators, and others to support compliance and uphold participant safety as the updated regime, which includes broader offences and a proportionate approach to enforcement, comes into effect ahead of 28 April 2026.
- 12th January: International Council for Harmonisation (ICH) E6R3 Annotations. UK-specific annotations to the ICH E6(R3) Good Clinical Practice guideline to help sponsors, investigators and others running clinical trials in the UK understand how ICH E6(R3) should be interpreted alongside applicable UK regulatory requirements and guidance. It clarifies expectations on authorisation, ethics, consent, safety reporting, data protection, and other key elements of trial conduct within the UK regulatory framework.
- 12th January: Declaration of Helsinki and Clinical Trial Regulations alignment. Explains how the amended UK Clinical Trials Regulations require compliance with the ethical principles of the Declaration of Helsinki for all clinical trials, while making clear that if those principles conflict with UK law, sponsors must prioritise the regulations and document their rationale and impact.
- 12th January: Archiving and retention of clinical trial records. Outlines responsibilities for sponsors and investigators to securely retain essential trial documents, such as trial master files, consent forms, and case report forms, in a way that preserves data integrity and enables regulatory inspection. It clarifies retention periods (generally at least 25 years after trial conclusion under Regulation 31A), requirements for electronic and paper records, named persons responsible for archiving, handling of record ownership transfers, and rules on destruction and transitional provisions for trials under previous regimes.
FDA – Draft Guidances
- 9th January: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products. provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of Bayesian methods in clinical trials.
Updated Guidance
MHRA
- 11th December: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Multiple updates have been published, including reporting data on BIA-ALCL and the addition of a table to show diagnoses after several years since implantation.
- 12th December: Good clinical practice for clinical trials. The GCP inspection dossier clinical trial spreadsheet was updated.
- 15th December: Medical devices: get regulatory advice from the MHRA. Changed to add a point on informal guidance under ‘the purpose of this guidance’ and updated attachment ‘Ask for Regulatory Advice’
- 12th January: Clinical trials regulations: transitional arrangements. A clarification was added to the guidance stating that NIMPs are not included in the Part 7 (labelling) transitional arrangements.
- 12th January: Clinical trials for medicines: ending a clinical trial. Text was added to state that all sponsors will need to notify the authorities of the date on which the first participant was recruited through an MOID.
- 12th January: Clinical trials that include an in vitro diagnostic device. Clarifies documentation requirements where the device is not UKCA or CE marked, and the health institution exemption does not apply. Created publication ‘Figure 1. Application process for clinical trials, including an IVD’.
- 14th January: Early Access to Medicines Scheme: Overview. Updated scientific opinion dates for EAMS 2026 were published.
- 15th January: Medical devices: conformity assessment and the UKCA mark. Updated to add a new Conformity assessment flow chart.
- 15th January: Register medical devices to place on the market. Published Device Registration Fee Changes from 1 April 2026 recording.
FDA – Final Guidances
- 2nd December: QTc Information in Human Prescription Drug and Biological Product Labelling. Assists applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labelling of non-antiarrhythmic human prescription drugs and biological products.
- 10th December: Promotional Labelling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers. Addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labelling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act.
- 15th December: Enhancing Participation in Clinical Trials – Eligibility Criteria, Enrolment Practices, and Trial Designs. Recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrolment of a representative population in their clinical trials.
- 15th December: Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies. Provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies.
- 16th December: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs. Assists applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval.
- 22nd December: Processes and Practices Applicable to Bioresearch Monitoring Inspections. covers the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspection-related conduct.
Industry News
eXmoor Pharma and UCL Partner to Accelerate Cell and Gene Therapies
On 2nd December, UK-based cell and gene therapy CDMO eXmoor Pharma and the Translational Research Office at University College London (UCL) announced a strategic collaboration to accelerate the translation of academic innovations into clinical-ready therapies. The partnership gives UCL researchers early access to eXmoor’s CMC consulting, regulatory strategy support, laboratory, and GMP manufacturing capabilities, while enabling closer academic-industry alignment to reduce development risk, cost, and complexity on the path to clinical trials.
FDA Launches TEMPO Pilot to Expand Access to Digital Health Tools for Chronic Disease
On 5th December, the FDA announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, a first-of-its-kind initiative to ease regulatory requirements and expand safe access to digital health devices for chronic conditions, working with Medicare’s ACCESS care model to collect real-world data and support innovation in technologies that improve patient outcomes.
MRM Health Joins Forces with Oncode & NKI on Microbiome Cancer Immunotherapy
On 17th December, MRM Health announced a strategic research collaboration with the Oncode Institute and the Netherlands Cancer Institute (NKI) to accelerate the development of microbiome-based live biotherapeutic products designed to enhance the effectiveness of immune checkpoint inhibitors in cancer treatment, combining MRM’s CORAL® platform with leading tumour microbiome and translational oncology expertise.
GSK Strikes US Deal to Boost Access to Respiratory Medicines
On 19th December, GSK announced it had entered a voluntary agreement with the US government to lower the cost of prescription drugs and broaden access to its respiratory treatments for millions of Americans, delivering on key government pricing priorities and aiming to benefit patients with conditions such as asthma and COPD.
Johnson & Johnson Submits OTTAVA Robotic Surgical System to FDA for De Novo Review
On 7th January, Johnson & Johnson announced it has submitted its OTTAVA™ Robotic Surgical System to the FDA in a De Novo classification request, seeking market authorisation for a next-generation, soft-tissue surgical robot designed for a range of general surgery procedures. The submission is supported by clinical data from investigational studies and, if cleared, would position J&J as a major competitor in the surgical robotics market.
New Rapid-Acting Therapy for UK Parkinson’s Patients
On 7th January, Bial launched KYNMOBI® (apomorphine hydrochloride) in the UK, introducing the first sublingual film for the intermittent treatment of “OFF” episodes in adults with Parkinson’s disease whose symptoms are not adequately controlled by oral therapy. Designed to dissolve under the tongue for rapid relief, KYNMOBI aims to help patients manage sudden motor symptom fluctuations and improve daily functioning, supported by Phase III clinical data demonstrating its effectiveness and safety.
Storm Therapeutics & Alida Bio Unite on RNA Cancer Drugs
On 8th January, Storm Therapeutics and Alida Bio announced a strategic collaboration to accelerate the development of RNA-targeted cancer treatments, combining Storm’s RNA-modifying drug discovery platform with Alida Bio’s expertise in RNA biology and oncology to advance new therapeutic candidates more quickly.
New iPSC Manufacturing Platforms Aim to Broaden Cell Therapy Reach
On 13th January, Cellistic announced the launch of three new iPSC-based GMP manufacturing platforms aimed at advancing immuno-oncology and regenerative cell therapies. The platforms expand the company’s ability to produce high-quality, clinical-grade induced pluripotent stem cell products at scale and support flexible, compliant manufacturing for a broad range of next-generation cell therapy programs, helping developers accelerate their pathways from discovery to the clinic.
MHRA Reaffirms Paracetamol Safety in Pregnancy After New Evidence Review
On 17th January, the MHRA revealed a new systematic review and meta-analysis showing no evidence that paracetamol use during pregnancy is linked to autism, ADHD, or intellectual disability in children. The regulator reiterated that, when taken as directed, paracetamol remains the safest option for managing pain and fever in pregnancy and advised pregnant people to follow the guidance on the medicine and consult a healthcare professional with any questions.
Not Long to Go Until Our New GxP Essentials Course
Join us on Thursday, 22nd January, in central Edinburgh for a clear, practical introduction to the GxPs, delivered by our Head of QA, Shona Ross.
Priced at £180 incl. VAT, our 4-hour course breaks down the fundamentals of GMP, GCP, and GLP, why they matter and how the common requirements of data integrity, fit-for-purpose and robust processes drive compliance in an organisation. It cuts through the complexity, giving you the knowledge and confidence to work competently and compliantly from day one.
To save your spot or for more information, click here.
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