Company News
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Regulatory News
FDA Launches AI Tool to Boost Performance and Public Health Impact
On 2nd June, the FDA introduced Elsa, a generative Artificial Intelligence (AI) tool aimed at boosting efficiency for agency employees, including scientific reviewers and investigators. This cutting-edge tool modernises the FDA’s operations and harnesses AI capabilities to improve service delivery, ultimately benefiting the American public.
MHRA Opens Digital Hub in Leeds to Boost Health Innovation
On 5th June, the MHRA launched a new digital hub in Leeds to drive innovation in healthtech and support regional growth. Around 30 digital and data roles will be based there, with plans to expand. The move is part of the government’s “Places for Growth” strategy and aims to strengthen collaboration with local NHS, tech, and academic partners.
MHRA Strengthens Post-Market Surveillance Rules for Medical Devices in UK
On 16th June, the MHRA introduced significant new post-market surveillance rules for all UKCA- and CE-marked medical devices sold in the UK. Manufacturers are now required to actively gather real-world performance data, report serious incidents within 15 days (down from 30), and monitor trends to identify safety issues early. The changes also include stricter oversight of field safety notices. These reforms aim to enhance patient safety and set the stage for future regulatory improvements, including potential international cooperation.
MHRA Expands AI Airlock Programme to Accelerate Safe AI Healthcare Innovation
On 23rd June, the MHRA launched the second phase of its AI Airlock programme, a regulatory sandbox designed to safely test AI-powered medical devices. This expansion follows a successful pilot phase that included projects like OncoFlow, which developed AI tools for personalised cancer treatment plans, and Newton’s Tree, which tested AI risk monitoring systems in clinical settings. The programme aims to streamline regulatory processes and bring innovative healthcare technologies to patients more quickly. Applications for the second cohort are open until the 14th of July 2025.
MHRA Joins Global HealthAI Network to Lead on International AI Standards in Healthcare
On 24th June, the MHRA became the first member of the new HealthAI Global Regulatory Network, taking a leading role in shaping international standards for AI in healthcare. The UK will help monitor AI tool performance, share safety alerts, and contribute to global regulation. This builds on MHRA’s AI Airlock programme and collaborations with NICE and the NHS to ensure safe, effective AI adoption in the health system.
MHRA Issues June 2025 Safety Roundup
On 24th June, the MHRA published its monthly safety update, summarising the latest guidance and alerts for users of medicines and medical devices.
ICH E20 Draft Guideline Published on the ICH Website
On 25th June, the International Council for Harmonisation (ICH) has released the draft guideline for E20, focused on Dose Escalation Studies in Early-Phase Clinical Trials. This draft aims to improve the design, conduct, and evaluation of such studies.
EMA and HMA Issue Recommendations to Strengthen Supply Chain of Anti-D Immunoglobulins
On 25th June, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) released recommendations aimed at addressing vulnerabilities in the supply chain of anti-D immunoglobulins. These medicines are essential for preventing RhD immunisation during pregnancy, which can cause serious health risks to both the foetus and newborn.
MHRA Launches Consultation on ICH E21 Guideline for Pregnant and Breast‑feeding in Trials
On 3rd July, the MHRA has launched a consultation on the ICH E21 guideline, which aims to improve how pregnant and breast‑feeding individuals are included in clinical trials. The draft guidance outlines principles for safely conducting research in these populations, such as adjusting trial design, gathering relevant data, and assessing risk–benefit for both parent and child. Stakeholders are invited to review and comment to help shape the UK’s approach to inclusive and safe trial practices.
EU Launches Consultation on GMP Guidelines – EudraLex Volume 4
On 7th July, the European Commission launched a consultation on updates to EudraLex Volume 4, focusing on Chapter 4 and its Annex regarding personnel in pharmaceutical manufacturing. This consultation focuses on updates to the GMP guidelines related to documentation and the use of Artificial Intelligence in pharmaceutical manufacturing. Stakeholders can submit feedback until the deadline of 7th October 2025.
Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 4th June: Regulatory considerations for therapeutic use of bacteriophages in the UK. The MHRA has released its first guidance to support the development of bacteriophage medicines in the UK, specifically targeting the treatment of antibiotic-resistant infections. The new framework covers both standardised and personalised treatments, clarifies regulatory expectations, and supports clinical trials and compassionate use.
- 10th June: Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP). Guidance was published to explain how to apply for Clinical Trial Authorisation when using decentralised manufacture of investigational medicines. It requires a prior decentralised manufacture designation, a certified control site, and detailed quality and manufacturing information to ensure product consistency and compliance.
- 10th June: Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP). The MHRA published the UK’s first Good Manufacturing Practice (GMP) guidance for decentralised medicine production. It sets out quality and safety standards for producing treatments at or near the point of care, overseen by a licensed control site.
- 10th June: Decentralised Manufacture: Labelling. Guidance was issues to clarify requirements for medicines produced via decentralised manufacture under the updated regulations.
- 16th June: Device specific vigilance guidance: Coronary Stents and associated delivery systems. New guidance was published on safety reporting for coronary stents and delivery systems. It outlines which clinical events must be reported, helping manufacturers detect and respond to risks more effectively under updated post-market surveillance rules.
- 16th June: Device specific vigilance guidance: Coronary Stents and associated delivery systems. New guidance was published on safety reporting for coronary stents and delivery systems. It outlines which clinical events must be reported, helping manufacturers detect and respond to risks more effectively under updated post-market surveillance rules.
- 16th June: Device specific vigilance guidance: Artificial Heart Valves. The MHRA published guidance on reporting safety issues with artificial heart valves. It lists which incidents must be reported to improve monitoring and patient safety under new post-market rules.
- 17th June: Electronic Common Technical Document (eCTD) submissions update. Guidance was published explaining the MHRA’s updated requirements for submitting electronic Common Technical Documents (eCTDs). It mandates that all submissions must include complete historical sequences of documents to comply with International Council for Harmonisation (ICH) standards. If these sequences are missing, the submission will fail validation and won’t be processed until corrected.
- 23rd June: AI Airlock Background. The MHRA has released a background briefing for its AI Airlock programme – the UK’s first regulatory sandbox for AI as a Medical Device (AIaMD). The document explains the need to modernise regulation amid rapid AI innovation, describes collaboration with Approved Bodies, NHS, and DHSC, and outlines outputs such as pilot reports and guidance updates.
US Food & Drug Administration (FDA)
- 4th June: CVM GFI #287 – Raw Data for Safety and Effectiveness Studies. The FDA issued final guidance to provide recommendations to sponsors on submission of raw data. In addition, this guidance discusses how CVM uses the raw data during review of new animal drug applications and how the raw data allows CVM to have confidence in the information used to make regulatory decisions.
- 16th June: CVM GFI #287 – Raw Data for Safety and Effectiveness Studies. The FDA issued final guidance to describe the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA will use this information to set a review goal for a priority abbreviated new drug application (ANDA).
- 24th June: Conducting Remote Regulatory Assessments Questions and Answers. The FDA issued final guidance to describe the Agency’s thinking regarding its use of Remote Regulatory Assessments (RRAs), to help increase the industry’s understanding of voluntary and mandatory RRAs, and to facilitate FDA’s process for conducting remote assessments for FDA-regulated products outside of the COVID-19 public health emergency.
- 27th June: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance provides FDA’s recommendations to industry regarding cybersecurity device design, labelling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk.
Updated Guidance
MHRA
- 4th June: RegulatoryConnect. The MHRA removed the 2024 RegulatoryConnect webinars and added the RegulatoryConnect webinar, which was recorded on May 22nd, 2025.
- 9th June: MORE implementation. A link was added for ‘Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations’
- 6th June: Access, new active substance and biosimilar work sharing initiatives. The Operational Procedures attachment was updated to include the latest version.
- 9th June: Manufacturer’s Online Reporting Environment (MORE). A link was added for ‘Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations’
- 11th June: Licensing: how to apply. The ‘National assessment procedure for medicines’ was added.
- 16th June: Custom-made medical devices in Great Britain. The MHRA updated its guidance on custom-made medical devices in the UK to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
- 25th June: Medicines: clinical trials hub. Links were added for draft guidance, to support amendments that come into force on the 28th of April 2026.
- 30th June: Types of application for marketing authorisations (legal basis of applications). Additional information on the definition of each legal basis and requirements for supporting data was added.
FDA
- 5th June: Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs Draft guidance was issued to provide recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order (OTC000038) titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (hereinafter referred to as C001).
- 6th June: M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol Draft guidance was published to provide a harmonised format for protocol content, facilitating clearer communication among sponsors, regulators, and ethical oversight bodies. The FDA encourages stakeholders to review and comment on these draft documents to support the ongoing development of international clinical trial standards.
- 25th June: Unique Device Identifier Requirements for Combination Products Guidance was issued to outline the requirements, recommendations, and best practices for UDI labelling and for submission of information to the Global Unique Device Identification Database (GUDID) for such combination products.
- 25th June: Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labelling Recommendations Guidance was issued intended to clarify the key factors in calculating the aluminum content to ensure that the total aluminum exposure in parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides FDA’s recommendations regarding the aluminum concentration limits for small volume parenterals (SVPs) packaged as single doses or SVPs packaged in pharmacy bulk packages (PBPs).
Industry News
MHRA Warns Women on Skinny Jabs to Use Contraception
On 5th June, the MHRA has advised women taking GLP-1 weight-loss drugs like Ozempic and Wegovy to use effective contraception and avoid pregnancy during treatment and for two months after stopping. The guidance warns that these drugs aren’t safe during pregnancy or breastfeeding and may reduce the effectiveness of oral contraceptives. The MHRA also cautions against buying unregulated versions online.
European Commission Approves Santen’s Ryjunea® Eye Drops for Paediatric Myopia Treatment
On 5th June, Santen Pharmaceutical Co., Ltd. announced that the European Commission has granted market authorisation for Ryjunea® (atropine 0.1 mg/ml) to treat paediatric myopia progression in children aged 3 to 14. This approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is based on the Phase III STAR study. The study demonstrated a 30% reduction in myopia progression over two years compared to placebo.
MHRA Pauses IXCHIQ Chikungunya Vaccine in Over‑65s
On 9th June, the MHRA announced a temporary pause on the use of Valneva’s IXCHIQ live‑attenuated chikungunya vaccine for individuals aged 65 and over pending a safety review, prompted by 23 serious adverse events—including two fatalities—in recipients aged 62–89 reported globally. It’s a precautionary measure ahead of the vaccine’s UK rollout, expected from 18 June 2025. Use in adults aged 18–64 remains unchanged.
NHS Fast-Tracks New Ultrasound Liver Cancer Treatment
On 10th June, the NHS has fast-tracked a new ultrasound treatment called histotripsy for liver cancer. This non-invasive, pain-free therapy destroys tumours in a single 30-minute session, speeding recovery and reducing hospital stays. The UK is the first in Europe to offer this technology, thanks to streamlined approval processes.
Tagomics Receives £860K Innovate UK Grant for Colorectal Cancer Detection
On 10th June, Tagomics Ltd., a pioneering biomarker discovery and diagnostics company, announced it has been awarded £860k Innovate UK funding as part of the Biomedical Catalyst programme for the testing and development of innovative healthcare solutions from Innovate UK, the UK’s innovation agency, with the remaining funding contributed by Tagomics.
EMA Recommends Approval of First Vaccine for Swine Dysentery
On 13th June, the European Medicines Agency (EMA) issued a positive opinion for Biobhyo, the first vaccine to protect pigs from swine dysentery, a highly infectious disease caused by Brachyspira hyodysenteriae. Currently, no vaccine is authorised in the EU for this condition.
FDA Halts New Clinical Trials Exporting US Cells to Foreign Labs in Hostile Nations
On 18th June, the FDA announced an immediate review of new clinical trials involving the export of living cells from American citizens to adversarial nations for genetic modification, followed by re-infusion into US patients – sometimes without their awareness or consent.
First Treatment for MASH-Induced Liver Scarring Approved in US
On 20th June, the EMA recommended granting conditional marketing authorisation for Rezdiffra (resmetirom) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. MASH, a disease where fat builds up in the liver, can lead to cirrhosis and cancer if untreated.
EMA Recommends Conditional Approval for Zemcelpro in Treating Blood Cancer
On 20th June, the EMA recommended granting conditional marketing authorisation for Zemcelpro (dorocubicel), a stem cell therapy to treat adults with haematological malignancies (blood cancers). It is aimed at patients needing an allogeneic stem cell transplant (allo-HSCT) but lacking a suitable donor. Zemcelpro enhances the effectiveness of umbilical cord blood stem cells, which are typically in limited supply.
MHRA Unveils 2025-26 Business Plan to Drive Safety, Innovation & Growth
On 25th June, the MHRA outlined its priorities for 2025/26 – protecting public safety, enhancing regulatory efficiency and predictability, fostering innovation, and improving customer and employee experience. Key goals include strengthening safety monitoring via data-driven approaches, implementing agile, risk-proportionate regulation, and ensuring consistent performance in core services. The plan, aligned with the 2023–26 Corporate Plan, supports NHS goals and UK life sciences, backed by new digital systems and a path toward financial self-sufficiency.
MHRA Seizes 7.7million Illegal Medicine Doses in Global Crackdown
On 25th June, the MHRA announced it had seized 7.7 million doses of illegal medicines worth £17.2 million during Operation Pangea, a worldwide enforcement effort. It also removed 367 illegal websites and social media accounts and froze £1.4 million linked to criminal activity. The seized items included unlicensed painkillers and sleeping pills, with the MHRA warning of serious risks from buying medicines online.
MHRA Highlights AI Airlock, CERSIs and Global Collaboration for Safe AI in Healthcare
On 27th June, the MHRA published a blog detailing how its AI Airlock sandbox, Centres of Excellence for Regulatory Science and Innovation (CERSIs), and role in the HealthAI Global Regulatory Network are transforming AI medical device regulation. The Airlock allows real-world testing of AI tools with regulator support, while CERSIs offer guidance, tools and workshops to help developers navigate regulation Together, these initiatives aim to support innovation while ensuring AI healthcare products are safe and effective.
Sandoz Recalls Cefazolin Lot After Penicillin G Potassium Mistakenly Included
On 27th June, Sandoz announced a voluntary recall of one of Cefazolin for Injection, USP, 1g per vial, after Penicillin G Potassium was mistakenly included in the carton. This error could lead to serious health risks, including allergic reactions and cardiac issues. No adverse events have been reported. Healthcare providers should stop using the affected lot (Lot PG4360, expiring November 2027) and contact Sedgwick for returns.
EMA Begins Review of Sodium Oxybate for Alcohol Dependence
On 25th June, the EMA announced the review of sodium oxybate medicines for treating alcohol withdrawal syndrome and supporting long-term abstinence in alcohol-dependent patients. This follows concerns raised by the French medicines agency about its effectiveness and potential misuse, based on data from three studies.
FDA Removes REMS for CAR T Cell Therapies, Easing Access to Blood Cancer Treatments
On 27th June, the FDA eliminated REMS for BCMA- and CD19-directed CAR T cell therapies used to treat blood cancers. The agency determined these treatments can be safely administered without the additional safety program, as their risks are now adequately covered in product labelling. This change simplifies access to therapies like Abecma and Yescarta, while maintaining ongoing safety monitoring and long-term studies.
UCB Reports Positive Phase 3 Results for Fenfluramine in CDKL5 Deficiency Disorder
On 27th June, UCB announced that its Phase 3 study evaluating adjunctive fenfluramine in CDKL5 Deficiency Disorder (CDD) met its primary and key secondary endpoints. The randomized, double-blind, placebo-controlled trial involved 87 participants aged 1 to 35 years with uncontrolled seizures associated with CDD. Fenfluramine demonstrated a significant reduction in seizure frequency compared to placebo. UCB plans to submit these results for regulatory approval to provide a treatment option for individuals with CDD.
VarmX Receives FDA IND Approval for Phase 3 Trial of VMX-C001 in Urgent Surgery
On 8th July, VarmX, a Dutch biotech company, announced that the FDA has cleared its Investigational New Drug (IND) application for VMX-C001. This approval paves the way for the launch of the EquilibriX-S Phase 3 trial, a global study assessing the efficacy of VMX-C001 in restoring blood coagulation in patients undergoing urgent surgery while on Factor Xa Direct Oral Anticoagulants (FXa DOACs).
Actithera Raises $75.5M Series A to Advance Precision Radioligand Therapy
On 9th July, Actithera, a biotech company based in Oslo and Cambridge, announced the close of a $75.5 million Series A financing round. The funding will support the clinical development of Actithera’s lead fibroblast activation protein (FAP)-targeting radioligand therapy candidate and the expansion of its proprietary discovery platform designed to improve tumor retention and safety. The round was co-led by M Ventures, Hadean Ventures, Sofinnova Partners, and 4BIO Capital, with additional investors joining the syndicate.
Summer in Edinburgh: Top Things to Do and See
Summer in Edinburgh is simply unforgettable, even in the rain! With its stunning skyline, mix of historic charm and modern flair, plus breathtaking scenery, it’s no wonder Edinburgh is one of the world’s most beautiful cities.
If you’re wondering where to begin exploring, we’ve got you covered. From the medieval streets of the Old Town to panoramic views atop Arthur’s Seat, world-famous festivals, delicious street food, and spine-tingling ghost tours – here’s our guide to experiencing the very best of Tower Mains’ home city.
Ready to fall in love with Edinburgh? Let’s dive in.
Issue Number: WN00199
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