Regulatory News
FDA Launches PreCheck Pilot to Strengthen US Pharmaceutical Manufacturing
On 1st February, the FDA launched the PreCheck pilot program, designed to strengthen the domestic pharmaceutical supply chain by providing earlier regulatory engagement and streamlined assessments for new US manufacturing facilities. The initiative aims to encourage domestic drug production and improve regulatory predictability for companies developing new manufacturing sites.
FDA Plans Crackdown on Non-Approved GLP-1 Drugs
On 6th February, the FDA announced its intention to act against non-FDA-approved GLP-1 drugs, particularly compounded versions being mass-marketed as alternatives to approved treatments. The agency plans to restrict the use of GLP-1 active ingredients in these products to protect patients from medicines whose quality, safety, and efficacy cannot be verified.
MHRA Launches Consultation on Indefinite Recognition of CE-Marked Medical Devices
On 16th February, the MHRA launched a consultation on proposals to indefinitely recognise CE-marked medical devices in Great Britain. The consultation, open until 10 April 2026, seeks stakeholder views on maintaining long-term recognition of devices compliant with EU regulations to ensure continued patient access and stable supply of medical technologies while supporting the UK’s evolving medical device regulatory framework.
EUHPP Webinar Highlights Evidence and Best Practices to Increase Biosimilar Uptake Across the EU
On 20th February, the European Commission published the presentation and recording of the EUHPP Live Webinar on biosimilars policies and best practices, which shared findings from the AUGMENT Biosimilars study. The webinar discussed evidence from 32 European countries and highlighted policy approaches and best practices to increase the uptake of biosimilars across Europe.
Recruitment Opens for Next Executive Director of the European Medicines Agency
On 20th February, the European Medicines Agency (EMA) announced the opening of the recruitment procedure for its next Executive Director. Applications are open until 19TH March 2026, with the selected candidate expected to succeed Emer Cooke, whose mandate ends in April 2027.
MHRA Issues Statement on the PATHWAYS Puberty Blocker Trial
On 20th February, the MHRA issued a statement on the PATHWAYS clinical trial, which will study the effects of puberty-suppressing medicines in children and young people with gender incongruence. The agency clarified its regulatory role in authorising the clinical trial, emphasising that it meets required safety and regulatory standards and aims to generate robust evidence on the benefits and risks of puberty blockers, where current data are limited.
ICH Releases Final Training Module for E2B(R3) Safety Reporting Guideline
On 22nd February, the International Council for Harmonisation (ICH) released the final training module supporting implementation of the E2B(R3) guideline on the electronic transmission of individual case safety reports (ICSRs). Developed by the E2B(R3) Expert and Implementation Working Group, the module outlines the technical and practical aspects of electronic ICSR submissions in line with E2B(R3) specifications, supporting harmonised safety reporting and regulatory information exchange between regulators and the pharmaceutical industry.
FDA Launches Framework to Accelerate Individualised Therapies for Ultra-Rare Diseases
On 23rd February, the FDA launched a new draft framework (“Plausible Mechanism Framework”) to support the development and approval of individualised therapies for ultra-rare genetic diseases. The approach allows regulators to rely on strong biological evidence and limited clinical data to evaluate treatments tailored to very small patient populations.
MHRA Safety Roundup Highlights New Medicine and Device Safety Alerts
On 25th February, the MHRA published its February 2026 Safety Roundup, summarising recent safety advice for medicines and medical devices. Key updates include warnings about falsified Mounjaro (tirzepatide) injection pens, safety signals for semaglutide linked to rare optic nerve damage, strengthened warnings on pancreatitis with GLP-1 medicines, and updated restrictions on the IXCHIQ chikungunya vaccine.
FDA Grants Second Approval Under National Priority Voucher Pilot
On 26th February, the FDA granted the second approval under its Commissioner’s National Priority Voucher (CNPV) pilot program for the lung cancer drug Hernexeos (zongertinib). The program aims to accelerate review of medicines addressing critical national health priorities, enabling faster regulatory decisions – this application was approved 44 days after filing.
Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 16th February: Timelines for acceptance of CE-marked medical devices in Great Britain (GB). The UK has launched a consultation on proposals for indefinite recognition of CE-marked medical devices. It will run from 16th February until 10th April 2026.
- 20th February: Get more help to apply for medicines, Integrated Scientific Advice (ISA). The UK has launched a consultation on proposals for indefinite recognition of CE-marked medical devices. It will run from 16th February until 10th April 2026.
- 20th February: Medicines: Get integrated scientific advice from the MHRA and NICE. Guidance on using the Integrated Scientific Advice service from the MHRA and the National Institute for Health and Care Excellence (NICE).
- 26th February: Strengthening supply chain cyber security at the MHRA. Explains how the MHRA is strengthening cybersecurity across its supply chain by introducing the Risk Ledger platform to assess and monitor supplier security controls. Suppliers may be invited to complete a cybersecurity profile to ensure that appropriate protections are in place. The aim is to reduce cyber risks that could impact regulatory operations, supply chains, and patient safety.
US Food & Drug Administration (FDA) – Draft Guidances
- 11th February: Certification Process for Designated Medical Gases. Issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry.
- 23rd February: Considerations for the use of the Plausible Mechanism Framework to Develop Individualised Therapies that Target Specific Genetic Conditions with Known Biological Cause. Issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry.
- 3rd March: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers. Intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement.
European Medicines Agency (EMA)
- 4th March: Guidance on the conduct of clinical trials during public health emergencies. Outlines how trials should be conducted during crises such as pandemics. It emphasises rapid initiation of well-designed, large, and coordinated clinical trials while maintaining patient safety, ethical standards, and data quality. The guidance encourages adaptive and platform trial designs, international collaboration, and regulatory flexibility to accelerate evidence generation. It also allows practical adaptations to ensure trials can continue despite disruptions.
Updated Guidance
MHRA
- 9th February: Good pharmacovigilance practice (GPvP). Updated to include a link to the EU Commission Implementing Regulation (CIR) HMR Schedule 12A Marketing Authorisation Holders (MAH) communication
- 9th February: Pharmacovigilance following agreement of the Windsor Framework. Updated to include wording on CIR 520/2012 and link to further information.
- 13th February: Blood: authorisations and safety reporting. Text for compliance reports updated (2026).
- 17th February: Clinical trials for medicines: modifying a clinical trial approval. The row relating to changes to approved IMP or non-investigational medicinal product labelling has been removed from the Route A substantial and minor modifications table. This clarifies that labelling changes may still be submitted as a Route A substantial modification or, following risk assessment, as a minor modification. However, because labelling is always UK-specific, such changes cannot be submitted as a Route B substantial modification.
- 20th February: Register medical devices to place on the market. Updates include new registration requirements for Northern Ireland, effective 28 May 2026, alongside revised fees guidance clarifying fee waivers and introducing Northern Ireland-specific fees. Minor text updates have also been made regarding IVDs undergoing performance evaluation and Coronavirus Test Device Approval (CTDA) registration.
- 24th February: National assessment procedure for medicines. Video removed to improve clarity within the guidance on national assessment procedures.
- 27th February: Good clinical practice for clinical trials. New CAPA guidance for formulating responses to GCP inspection findings was added.
- 2nd March: MHRA Portal: register to submit forms. The MHRA Portal registration form and updated guidance were added.
- 2nd March: Early Access to Medicines Scheme: Overview. Updated EAMS Submission dates to run until 2028.
- 4th March: Contact the MHRA. New contact information was added to the Whistleblower section.
- 4th March: Find product information about medicines. The February 2026 Additional Monitoring List was added.
- 4th March: Medicines: get scientific advice from MHRA. The section on joint advice has been updated to reflect and link to the MHRA and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice service.
EMA
- 26th February: Q&A on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products. Q&A on the use of out-of-specification (OOS) batches of authorised cell/tissue-based advanced therapy medicinal products (ATMPs) explains when a batch that does not fully meet quality specifications may still be used in patients.
FDA – Final Guidances
- 3rd February: Computer Software Assurance for Production and Quality Management System Software. Provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system.
- 3rd February: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions. Provides recommendations to industry regarding cybersecurity device design, labelling, and the documentation that the FDA recommends be included in pre-market submissions for devices with cybersecurity risk.
- 12th February: Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals. The framework outlined in this guidance is intended to facilitate voluntary changes to have all medically important antimicrobial new animal drugs administered in alignment with the principles of judicious use.
- 4th March: M14 General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines. Intended to streamline the development and regulatory assessment of post-marketing non-interventional safety studies that include real-world data.
- 4th March: E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. Clarifies the use of new post-approval safety sources and updates terminology and standards for post-approval adverse event reporting.
Industry News
THX Pharma and Biocodex Sign €173M Licensing Deal for Rare Disease Therapies
On 10th February, THX Pharma and Biocodex announced a strategic licensing agreement covering three rare diseases: Batten disease, Gaucher disease, and Niemann-Pick type C. The deal – valued at up to €173 million – grants Biocodex global rights to develop and commercialise Batten-1 and rights in the US and Canada for TX01, with THX Pharma leading clinical development of the programs.
MHRA Introduces New Restrictions on Chikungunya Vaccine IXCHIQ After Safety Review
On 11th February, the MHRA announced additional restrictions on the use of the chikungunya vaccine IXCHIQ following a safety review. The vaccine should now only be used in adults aged 18–59 and is contraindicated in people aged 60 or over and in those with conditions such as hypertension, heart disease, diabetes, or chronic kidney disease, after reports of rare, serious adverse reactions globally.
European Life Sciences Coalition Launched to Boost Investment in Biotech Sector
On 12th February, the European Life Sciences Coalition (ELSC) was launched in association with Invest Europe to strengthen Europe’s life sciences and biotechnology investment ecosystem. The coalition brings together leading venture capital firms, research organisations, and industry stakeholders to mobilise greater public and private investment and address structural barriers limiting the growth and scaling of European biotech companies.
FDA Approves Labelling Changes for Menopausal Hormone Therapy Products
On 12th February, the FDA approved labelling changes for several menopausal hormone therapy (HRT) products to better reflect current scientific evidence on their benefits and risks. The updates remove certain risk statements, such as those related to cardiovascular disease, breast cancer, and probable dementia, from boxed warnings, aiming to provide more accurate information for patients and healthcare providers.
FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
On 12th February, the FDA approved Optune Pax, the first device therapy for adults with locally advanced pancreatic cancer. The portable, non-invasive device delivers tumour-treating electrical fields (TTFields) to disrupt cancer cell division and is used alongside chemotherapy.
MHRA Warns Against Risky Online Purchases After Seizure of 20 Million Illegal ED Pills
On 13th February, the MHRA warned the public about the dangers of buying medicines online after nearly 20 million illegally traded erectile dysfunction pills were seized in the UK between 2021 and 2025, including 4.4 million in 2025 alone. Many of the seized pills were sold through unregulated websites and were found to contain incorrect doses, hidden drugs, or toxic ingredients, highlighting the risks of purchasing unauthorised medicines.
Nuclera and leadXpro Partner to Accelerate Structure-Based Drug Design for Membrane Proteins
On 17th February, Nuclera and leadXpro announced a scientific partnership to accelerate structure-based drug design for complex membrane protein targets. The collaboration combines Nuclera’s rapid multiplex membrane protein screening technology with leadXpro’s AI-driven construct design and structural biology expertise, creating an end-to-end workflow aimed at improving access to difficult drug targets and speeding early drug discovery.
AlzeCure Secures EU Grant to Advance Phase 2 Alzheimer’s Drug Trial
On 17th February, AlzeCure Pharma announced it had received a €2.5 million grant from the EU’s European Innovation Council (EIC) to support a Phase IIa clinical trial of NeuroRestore ACD856 for Alzheimer’s disease. The funding will help evaluate higher doses of the drug candidate, a novel Trk receptor modulator designed to enhance BDNF and NGF signalling, to improve memory function and potentially modify disease progression.
SolasCure Reports Phase II Results Showing Accelerated Healing with Aurase Wound Gel
On 18th February, SolasCure announced the completion of a Phase II clinical trial of Aurase Wound Gel, showing accelerated healing in chronic wounds. The investigational gel contains tarumase, an enzyme derived from medical maggots, which promotes wound healing by selectively breaking down damaged tissue and preparing the wound bed for recovery.
UK Medical Device Testing Reaches Record High as MHRA Supports Brain and AI Technologies
On 19th February, the MHRA announced that medical device testing reached a record high, with 17% more clinical investigations approved in 2025 compared with 2024. The agency also introduced new initiatives to support innovation in neurotechnology and artificial intelligence, aiming to attract more cutting-edge device development and improve patient access to advanced healthcare technologies.
MHRA Licenses First Medicine Specifically for Non-CF Bronchiectasis
On 25th February, the MHRA licensed brensocatib as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients aged 12 years and older. The oral therapy targets the inflammation driving the disease and offers a new treatment option for a chronic lung condition that previously had no approved targeted therapies.
EMA Recommends New Targeted Therapy for Paediatric Low-Grade Glioma
On 27th February, the EMA recommended granting a conditional marketing authorisation for Ojemda to treat children aged 6 months and older with paediatric low-grade glioma with BRAF gene alterations whose disease has progressed after prior treatment. The once-weekly oral targeted therapy aims to address an unmet need for patients with limited treatment options.
CHMP Recommends Expanded EU Use of Lilly’s Olumiant for Adolescents with Alopecia Areata
On 27th February, Eli Lilly announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended expanding the EU approval of Olumiant (baricitinib) to include adolescents aged 12–17 with severe alopecia areata. The recommendation is based on results from the Phase 3 BRAVE-AA-PEDS study, and a final decision from the European Commission is expected in the coming months.
EMA Recommends First Combined COVID-19 and Influenza Vaccine for Adults 50+
On 27th February, the EMA recommended granting EU marketing authorisation for mCombriax, the first combined mRNA vaccine designed to protect people aged 50 years and older against both COVID-19 and seasonal influenza. The single-shot vaccine aims to simplify vaccination while generating immune responses comparable to receiving separate COVID-19 and flu vaccines.
FDA Warns 30 Telehealth Companies Over Illegal Marketing of Compounded GLP-1 Drugs
On 3rd March, the FDA issued warning letters to 30 telehealth companies for making false or misleading claims about compounded GLP-1 products used for weight loss and diabetes. The FDA said some firms implied their compounded drugs were the same as FDA-approved medicines or obscured their sourcing, stressing that compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness, or quality.
Theolytics Secures €8M Horizon Europe Grant to Advance Ovarian Cancer Therapy
On 4th March, Theolytics announced it has been awarded €8 million in Horizon Europe 2025 grant funding to support a Phase 2a expansion of the OCTOPOD-IV trial evaluating THEO-260, an oncolytic immunotherapy for platinum-resistant ovarian cancer. The funding will help advance clinical research across international centres and further investigate the therapy’s dual mechanism targeting cancer cells and cancer-associated fibroblasts while activating immune responses.
25 Lessons from 25 Years of GxP Audits
Auditing is often perceived as a technical exercise built around checklists and findings. In reality, it is far more nuanced and human, shaped by preparation, communication, judgment, and an ability to understand how systems operate in practice, not just on paper.
As part of our 25 Years of Tower Mains series, we’re reflecting on what decades of experience have really taught us. Over time, you start to notice patterns – some reassuring, some surprising, and some learned the hard way.
In our latest blog, we share 25 things we’ve learned from 25 years of GxP audits: practical insights, honest observations, and lessons that only experience can teach. If you work in QA, operations, or leadership, there’s a good chance you’ll recognise more than a few of them.
To read more, click here.
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