Regulatory News
EMA and FDA Set Common Principles for AI Use in Medicine Development
On 14th January, the European Medicines Agency (EMA) and the FDA jointly issued a set of ten guiding principles for the responsible use of artificial intelligence (AI) in drug development. These principles provide broad guidance on how AI should be used across the entire medicines lifecycle to support innovation while safeguarding patient safety. The shared framework aims to foster international regulatory alignment and will inform future AI‑related guidance in both jurisdictions.
EMA Confirms Use of Paracetamol During Pregnancy Remains Unchanged in the EU
On 20th January, the EMA reaffirmed that paracetamol (acetaminophen) can continue to be used during pregnancy in the EU for pain or fever when clinically needed, with no changes to current recommendations.
Ilona Reischl Re‑elected Chair of EMA’s Committee for Advanced Therapies
On 23rd January, the EMA announced that Dr Ilona Reischl has been re‑elected as Chair of the Committee for Advanced Therapies (CAT) for a further three‑year mandate beginning in February 2026.
MHRA Takes Over Chair of the Access Consortium for 2026
On 26th January, the MHRA formally began its term as chair of the Access Consortium, a collaboration among regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland. The role aims to strengthen international cooperation to streamline regulatory processes, support innovation, and improve public health outcomes globally.
MHRA Safety Roundup: January 2026
On 27th January, the MHRA published its latest Safety Roundup, summarising key risk minimisation and safety information for medicines and medical devices. Highlights include changes to isotretinoin prescribing guidance, strengthened warnings for gabapentinoids, benzodiazepines and z‑drugs, medicine recalls and notifications, and clinical advice on semaglutide dosing and vaccine information.
MHRA Updates Guidance for GLP‑1 Prescribers and Patients
On 29th January, the MHRA updated product information for healthcare professionals and patients regarding the small risk of severe acute pancreatitis associated with Glucagon‑Like Peptide‑1 (GLP‑1) and dual GLP‑1/GIP receptor agonists, reinforcing safety advice and regulatory information.
FDA Launches PreCheck Pilot to Support US Pharmaceutical Manufacturing
On 1st February, the FDA launched the PreCheck Pilot Program to strengthen the US pharmaceutical supply chain and support new domestic manufacturing facilities. Participating sites will receive early guidance on facility design, quality systems, and operational readiness before submitting product applications. The program prioritises facilities producing critical medicines, aiming to increase regulatory predictability and accelerate the availability of essential treatments in the US.
MHRA Strategy Blog Series: Shaping Future Regulation
On 2nd February, the MHRA updated its Strategy Blog Series, featuring expert perspectives on topics like personalised medicine, AI in healthcare, patient safety, and health equity. The series informs the MHRA’s upcoming five‑year strategy and encourages discussion with stakeholders.
FDA Formally Issues Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850)
On 2nd February, the FDA formally issued Compliance Program 7382.850 – Inspection of Medical Device Manufacturers, which significantly updates how inspectors evaluate medical device and IVD manufacturers under the newly effective Quality Management System Regulation (QMSR).
Registrations Open for Live Webinar on Biosimilars and AUGMENT Study Insights
On 9th February, the Directorate‑General for Health and Food Safety opened registrations for a European Union Health Policy Platform (EUHPP) live webinar on biosimilars, showcasing best practices and evidence from the AUGMENT Biosimilar study. The webinar will take place on the 19th of February 2026, from 11:00 to 12:00 CET.
MHRA Inspectorate Blog Explains Impact of Amended CIR 520/2012 on UK Medicines
On 10th February, the MHRA Inspectorate released a blog on the impact of the amended EU CIR 520/2012 on UK‑authorised medicines. It outlines which pharmacovigilance provisions apply to different product categories, helping marketing authorisation holders determine when to follow the amended EU rules versus UK-specific requirements. The blog also includes practical tools, such as a decision-making flowchart, to support compliance with both UK and applicable EU regulations.
Published Guidance
MHRA
- 12th January: Clinical Trials Regulations Enforcement Provisions. The guidance document clarifies that, following the amended Clinical Trials Regulations, the scope of provisions that may give rise to an infringement notice or offence has been broadened, largely to align with legislative changes introduced by the amendment.
- 12th January: International Council for Harmonisation (ICH) E6R3 Annotations. This document supports UK clinical trial stakeholders by clarifying the relevant UK regulatory requirements and guidance referenced within the guideline.
- 12th January: Declaration of Helsinki and Clinical Trial Regulations Alignment. This guidance clarifies that the amended Clinical Trials Regulation requires compliance with the principles of the Declaration of Helsinki, while no longer referencing a specific version of the Declaration.
- 12th January: Archiving and retention of clinical trial records. Defines the responsibilities for the archiving and retention of clinical trial records to ensure compliance with Good Clinical Practice (GCP) and regulatory standards.
- 9th February: Updates to CIR 520/2012 – Information for UK Marketing Authorisation Holders. Clarifies the expectations for applying the additional pharmacovigilance provisions outlined in the updated CIR 520/2012 for UK-authorised products.
FDA – Draft Guidances
- 20th January: M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. Intended to establish a globally harmonised framework for organising and presenting quality data included in registration applications for medicinal products for human use.
- 21st January: Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval. Provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) in multiple myeloma as primary endpoints in trials evaluating drug and biological products intended to treat patients with multiple myeloma (MM) to support approval under accelerated approval.
- 23rd January: Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation. Provides the FDA’s recommendations on clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices.
- 6th February: E22 General Considerations for Patient Preference Studies. Provides general principles for the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals.
Updated Guidance
MHRA
- 2nd January: Operational Information Sharing. Updated to reflect the addition of the Department of Health Northern Ireland to the list of Health System Partners.
- 12th January: Clinical Trials for Medicines: Expert Advice. Date for submission of application updated to 28 days before the Clinical Trials Borderline and Veterinary Exemptions Advisory Group (CTBVEAG) meeting from 14 days.
- 12th January: Clinical Trials For Medicines: Ending A Clinical Trial. Additional text specifies that all sponsors are required to notify the authorities of the date of first participant recruitment via the Medicines and Healthcare products Regulatory Agency (MHRA) Online Information Database (MOID).
- 12th January: Clinical Trials That Include An In Vitro Diagnostic Device. Documentation requirements were clarified for non-UKCA/CE-marked devices where the health institution exemption does not apply.
- 12th January: MHRA Fees. Updated MHRA Fees document, point 6, notes, to reflect that there is no longer a phase IV notification scheme.
- 12th January: MORE Submissions – User Reference Guide. The MORE submissions guide was updated to include guidance on the new report reassignment feature, enabling users to reassign reports to the correct manufacturer or responsible person within the MORE portal.
- 21st January: International Recognition Procedure. Updated dates indicating the submission deadlines for IRP Route B applications.
- 23rd January: Early Access to Medicines Scheme: Overview. Updated to add amended dates for the Early Access to Medicines Scheme (EAMS) 2026.
- 27th January: Submission And Assessment Timetables for Innovative Medicines Applications. Updated to add a new list of dates to Section 2
- 4th February: Medicines: Terminated and Cancelled Manufacturing and Wholesale Dealer Licences. Updated to include the file: “List of Cancelled, Terminated and Revoked Licenses – February 2026.”
FDA – Final Guidances
- 6th January: General Wellness: Policy for Low-Risk Devices. Clarifies the FDA’s interpretation of this provision and its application to general wellness products.
- 29th January: Clinical Decision Support Software. This guidance clarifies the FDA’s thinking on the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act (“Non-Device CDS criteria”).
- 3rd February: Computer Software Assurance for Production and Quality Management System Software. Describes a risk-based approach to establish confidence in the automation used for production or quality management systems, identify where additional rigour may be appropriate, and various methods and testing activities that may be applied to establish computer software assurance.
- 3rd February: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions. Provides the FDA’s recommendations to industry regarding cybersecurity device design, labelling, and the documentation that the FDA recommends be included in premarket submissions for devices with cybersecurity risk.
Industry News
FDA Approves First‑Ever Treatment for Children with Menkes Disease
On 12th January, the FDA approved the Zycubo injection as the first treatment for Menkes disease in paediatric patients. Developed by Sentynl Therapeutics, Zycubo delivers copper subcutaneously to bypass the defective intestinal absorption that characterises this rare neurodegenerative disorder and has been shown to improve survival, particularly when started early in life.
AAX Biotech Teams Up with Vascurie to Fast‑Track Antibody Research
On 20th January, biotech company AAX Biotech announced a collaboration with Vascurie to advance high‑throughput antibody characterisation using AAX’s Seqitope® platform and automated infrastructure. The partnership will apply high‑resolution, parallel epitope mapping to Vascurie’s antibody candidates against the CD93 target to generate rapid, data‑rich insights and support the development of its neuro‑oncology therapeutic programme.
Akari Therapeutics Files Patent and Advances Second ADC
On 26th January, Akari Therapeutics filed a U.S. provisional patent for its second antibody‑drug conjugate (ADC) candidate, AKTX‑102, targeting CEACAM5-expressing solid tumours. The filing strengthens its intellectual property portfolio around its PH1 spliceosome‑modulating payload and differentiated antibody platform, supporting pipeline expansion in high‑unmet‑need cancers.
En Carta Diagnostics Receives FDA Breakthrough Device Designation for Lyme Test
On 28th January, En Carta Diagnostics, a Paris‑based deep tech diagnostics start‑up, announced that its EC Pocket Lyme rapid molecular test for early detection of Borrelia has been granted Breakthrough Device Designation by the FDA. The designation allows for priority review and increased collaboration with the FDA, potentially accelerating the path to market for the portable, point‑of‑need test that aims to detect infection earlier than current antibody‑based methods.
ERVimmune Raises €17M Series A to Advance Lead Cancer Vaccine into Clinic
On 29th January, immunotherapy biotech ERVimmune announced it has raised €17 million in a Series A first closing to support the clinical development of its lead cancer vaccine candidate. The funding will accelerate the company’s entry into human trials and advance its programme targeting tumour‑associated endogenous retroviral antigens, with the aim of improving immune responses against hard‑to‑treat cancers.
EMA Recommends First Immunotherapy‑Based Treatment for Advanced Anal Cancer
On 30th January, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Zynyz, in combination with carboplatin and paclitaxel chemotherapy, as a first‑line immunotherapy treatment for adults with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC), marking the first immunotherapy‑based option recommended in Europe for this rare, advanced cancer.
EMA Reviews Tavneos for Rare Autoimmune Diseases Over Data Integrity Concerns
On 30th January, the EMA announced a review of Tavneos (avacopan), used to treat adults with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), following concerns about data integrity in the pivotal ADVOCATE study. The review will reassess the benefit‑risk balance; no changes to patient use have been made at this stage.
EMA Recommends New Medicine for Chronic Graft‑Versus‑Host Disease
On 30th January, the EMA recommended granting a conditional marketing authorisation for Rezurock (belumosudil) to treat chronic graft‑versus‑host disease (cGVHD) in adults and children aged 12 years and older weighing at least 40 kg, when other treatment options are unsuitable or have failed.
Gedeon Richter and Fuji Strengthen Strategic Collaboration in Women’s Healthcare
On 3rd February, Gedeon Richter Plc and Fuji Pharma Co., Ltd. announced the expansion of their long‑standing strategic partnership, focusing on women’s healthcare. The strengthened collaboration builds on successes in products such as Alyssa® and Nextstellis™ and aims to accelerate joint business development, R&D, and external licensing opportunities globally, particularly in gynaecology and hormone‑related therapies.
FDA Signals Enforcement Against Non‑FDA‑Approved GLP‑1 Drugs
On 6th February, the FDA announced its intention to take decisive action against non‑FDA‑approved compounded GLP‑1 drugs that are being mass‑marketed as alternatives to authorised therapies. The agency said it will restrict the use of GLP‑1 active pharmaceutical ingredients (APIs) in these products, target misleading advertising claims, and use all available enforcement tools to address violations of federal law, emphasising that quality, safety and effectiveness cannot be verified for unapproved compounds.
Tower Mains Celebrates 25 Years
This year, Tower Mains celebrates 25 remarkable years!
To kick off our 25 Years of Tower Mains series, we take a nostalgic look back to 2001 – the year it all began – when flip phones were everywhere, dial-up tested our patience, and DVDs were replacing VHS tapes. From the music that got us moving, the films and TV shows that kept us entertained, and the sports moments that had us cheering, to the tech and gadgets that shaped daily life, our latest blog captures just how much the world has changed.
Today, as evolving regulations, AI, and cutting-edge technology continue to shape the industry, Tower Mains keeps growing, adapting, and delivering trusted, high-quality services.
To read more, click here.
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