Company News
ICH GCP E6 (R3) has officially come into effect in the UK, bringing a stronger focus on risk-based approaches, data integrity, and modern trial delivery. These changes will shape how clinical trials are designed, managed, and inspected.
To help organisations understand the practical impact, we’ve launched a one-day ICH GCP E6 (R3) training course. Delivered by industry-leading trainers, the course explores what the revised guideline means in day-to-day practice and what regulators will expect during inspections.
For more information, click here.
Regulatory Updates
MHRA Expands AI Airlock Programme With £3.6 Million Funding Boost
On 8th April, the MHRA announced a £3.6 million funding boost over three years to expand its AI Airlock programme, which supports the safe testing of AI-powered medical devices in real-world healthcare settings. The initiative aims to improve AI regulation, accelerate innovation, and strengthen the UK’s leadership in safe healthcare AI.
ICH Issues Training Module for M15 Guideline on Model-Informed Drug Development
On 9th April, the International Council for Harmonisation (ICH) announced the release of a new training module supporting implementation of the ICH M15 Guideline on Model-Informed Drug Development (MIDD). The module provides an overview of the guideline’s principles, including model evaluation, evidence assessment, and regulatory reporting, helping to harmonise global expectations for the use of modelling and simulation in drug development and regulatory decision-making.
FDA Reminds Sponsors and Researchers to Disclose Trial Results
On 13th April, the FDA announced that it had contacted more than 2,200 sponsors and researchers linked to over 3,000 clinical trials to remind them of their legal obligation to publish trial results on ClinicalTrials.gov. The agency highlighted concerns that failure to disclose negative findings creates publication bias and undermines transparency around the safety and effectiveness of medical products.
FDA Achieves Year 1 Goals in Reducing Animal Testing
On 20th April, the FDA announced it had achieved its first-year goals under its roadmap to reduce animal testing in drug development. The agency highlighted progress in adopting alternative methods such as AI models, organ-on-chip technologies, and other human-relevant approaches designed to improve drug safety assessment, accelerate development timelines, and reduce reliance on animal studies.
CMS and FDA Announce RAPID Coverage Pathway for Medical Devices
On 23rd April, the FDA and Centers for Medicare & Medicaid Services (CMS) announced the new RAPID (Regulatory Alignment for Predictable and Immediate Device) coverage pathway to speed up Medicare access to breakthrough medical devices. The initiative aligns FDA approval and Medicare coverage decisions earlier in development, potentially reducing reimbursement timelines from over a year to as little as two months for eligible breakthrough devices.
Launch of Major Reforms to Clinical Trial Regulations in the UK
On 27th April, the MHRA and Health Research Authority launched major reforms to UK clinical trial regulations – the biggest overhaul in over 20 years. The changes are designed to speed up approvals, simplify lower-risk trials, improve transparency, and accelerate patient access to innovative treatments while maintaining high safety standards.
MHRA Inspectorate Blog: Route B Substantial Modifications Pilot Results
On 27th April, the MHRA Inspectorate Blog published the results of its Route B substantial modifications pilot, designed to streamline approvals for low-risk changes to clinical trials. The pilot reduced average review times from 35 days to just 7 days, helping accelerate clinical research while maintaining participant safety ahead of new UK Clinical Trials Regulations coming into force.
MHRA Delivers Targets to Increase Access to Medicines
On 28th April, the MHRA announced it had met or exceeded all statutory targets aimed at improving access to medicines and medical devices, while reinforcing the UK’s position as a global hub for life sciences innovation. The update highlighted progress in clinical trial reform, AI regulation, international partnerships, and faster approvals to support patient access and investment in the UK healthcare sector.
EMA Launches Pilot to Support Breakthrough Medical Devices
On 28th April, the EMA launched a pilot programme to support the development of breakthrough medical devices and accelerate patient access to highly innovative technologies in the EU. The initiative will provide enhanced regulatory support and priority scientific advice for selected high-risk devices that address unmet medical needs or offer major advantages over existing treatments, while maintaining rigorous safety and performance standards.
MHRA Hires Top Global Tech Talent To Transform Systems Behind Regulation of Medicines and Medical Devices
On 29th April, the MHRA announced the appointment of Jason Bonander as its new Chief Digital and Technology Officer to help modernise the digital systems underpinning the regulation of medicines and medical devices. The move aims to strengthen the UK’s regulatory infrastructure, improve efficiency, and support innovation across the life sciences and healthcare sectors.
EMA Launches New Advisory Group on Vaccine Confidence
On 29th April, the EMA announced the launch of a new advisory group focused on strengthening vaccine confidence across the EU. The group will bring together experts from public health, healthcare, behavioural science, and patient communities to help address vaccine hesitancy, improve public communication, and support trust in vaccination programmes.
FDA Launches One-Day Inspectional Assessments
On 6th May, the FDA announced a pilot programme for one-day inspectional assessments to strengthen and expand regulatory oversight while making inspections more targeted and efficient. The shorter, risk-based assessments are designed to complement standard inspections, improve surveillance coverage, and reduce disruption for lower-risk facilities across areas including biologics, medical products, foods, and clinical research.
FDA Expands AI Capabilities and Completes Data Platform Consolidation
On 6th May, the FDA announced major upgrades to its internal AI capabilities, including the launch of Elsa 4.0 and the consolidation of more than 40 data systems into a new platform called HALO (Harmonised AI & Lifecycle Operations for Data). The initiative aims to modernise regulatory operations, improve data integration, and enable FDA staff to use AI tools more efficiently across scientific reviews, inspections, and regulatory workflows.
Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 15th April: RSV Vaccine Factsheet – Information for Patients, Parents and Carers. This factsheet is designed to help patients, parents and carers understand the RSV vaccines used in the UK.
- 17th April: National AI Commission: Ask Me Anything. The MHRA are hosting a live Ask Me Anything on how artificial intelligence (AI) is being regulated in healthcare.
- 28th April: Formulating responses to GCP inspection findings. This document aims to give assistance in how to respond to the GCP inspection report findings, increase awareness of the GCP Inspectors’ expectations and aid in the formulation of an acceptable response.
US Food & Drug Administration (FDA) – Draft Guidances
- 15th April: Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing. Provides recommendations for next-generation sequencing (NGS)-based methods used in nonclinical studies that will likely be needed to support initiation of clinical trials of investigational human genome editing (GE) products.
- 20th April: Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH-Approved Air-Purifying Respirators. Provides proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) in accordance with 42 CFR part 84
- 20th April: Establishing Impurity Specifications for Antibiotics. Provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis.
European Medicines Agency (EMA)
- 2nd April: Clinical Data Publication (CDP). Questions and Answers (Q&As) on the EMA policy on the publication of clinical data for medicinal products for human use (Policy 0070) work-share initiative with Health Canada (HC).
- 7th May: Recommendations on Eligibility to PRIME Scheme. Recommendations adopted at the CHMP (Committee for Medicinal Products for Human Use) meeting on eligibility requests for the PRIME (PRIority MEdicines) scheme, which supports medicines targeting unmet medical needs through enhanced regulatory and scientific support. The PRIME pathway is designed to accelerate the development and assessment of promising innovative medicines across the EU.
- 7th May: EMA PRAC Adopts New Safety Signal Recommendations. Updated product safety information following recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) at its 7th-10th April 2026 meeting. The recommendations included updates to medicine safety information and risk management measures based on newly identified or reviewed safety signals to help ensure the continued safe use of medicines across the EU.
Updated Guidance
MHRA
- 9th April: National assessment procedure for medicines. Updated to include a webinar recording covering the launch of the MHRA-NICE Aligned Pathway and Integrated Scientific Advice services.
- 9th April: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway. Added a webinar recording introducing the MHRA-NICE Aligned Pathway and Integrated Scientific Advice services.
- 10th April: Register medical devices to place on the market. Updated with a webinar recording on the launch of the MHRA-NICE Aligned Pathway and Integrated Scientific Advice services.
- 14th April: Medicines: Get integrated scientific advice from the MHRA and NICE. Added a webinar recording outlining the launch of the MHRA-NICE Aligned Pathway and Integrated Scientific Advice services.
- 27th April: Innovative Licensing and Access Pathway (ILAP). Updated ILAP performance metrics and application guidance documentation.
- 28th April: Clinical trials for medicines: Clinical Trials Regulations transitional arrangements. Clarified that previously approved labels do not need updating to replace terms such as “patient” or “subject” with “participant”, although use of “participant” is encouraged for labels approved after 28 April 2026. Also confirmed that the amended Clinical Trials Regulations are now fully effective and the guidance is no longer draft.
- 28th April: Clinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom. Confirms that the amended Clinical Trials Regulations are now fully effective and the guidance is no longer considered draft.
- 28th April: Clinical trials for medicines: ending a clinical trial. Clarifies that trial results already published do not need to be submitted to authorities within 12 months where a deferral is in place.
- 28th April: Clinical trials for medicines: Good clinical practice inspections. Updated and reorganised guidance to reflect recent clinical trial legislation changes, including revised references, updated links, and alignment with ICH E6(R3).
- 28th April: Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment. Removed reference to a specific version of the Declaration of Helsinki within the placebo/no intervention section.
- 28th April: Clinical trials for medicines: notifiable trials. Added the Confirmation of Notifiable Trial Criteria form and clarified that IND refers to investigational new drug.
- 28th April: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines. Added new ICH guidelines E6(R3) on Good Clinical Practice and E8(R1) on General Considerations for Clinical Studies.
- 29th April: Good laboratory practice (GLP) for safety tests on chemicals. Updated the list of current members within the UK GLP compliance programme.
- 30th April: The Innovative Devices Access Pathway (IDAP). Confirms a further extension for the HistoSonics EDISON™ System and Accessories until 30 October 2026.
- 6th May: Clinical investigations for medical devices. Removed the survey link from the further information section following closure of the survey.
- 7th May: Find product information about medicines. Updated the Additional Monitoring List for April 2026.
FDA – Final Guidances
- 15th April: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. Provides information for industry, researchers, physicians, institutional review boards, and patients about the implementation of the FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (21 CFR part 312, subpart I), which went into effect on October 13, 2009.
- 5th May: Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application. Describes how the FDA applies flexibility to the chemistry, manufacturing, and controls (CMC) requirements for human cellular and gene therapy (CGT) products being developed for biologics license applications (BLAs) under Title 21 of the Code of Federal Regulations (CFR) Part 601 (21 CFR 601).
- 6th May: Submitting Continuous Glucose Monitoring Data in Clinical Trials. Gives technical specifications for submitting continuous glucose monitoring (CGM) data in clinical trials to support a marketing application for a drug or biological product.
- 7th May: Patient-Matched Guides for Orthopaedic Implants. Recommendations on information to support premarket submissions for patient-matched guides for orthopaedic implants.
- 8th May: Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention. To assist sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI).
- 8th May: Post approval Pregnancy Safety Studies. Provides sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by the FDA (i.e., pregnancy safety studies) in the post approval setting.
- 8th May: Pulmonary Tuberculosis: Developing Drugs for Treatment. To assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB).
Industry News
Oxford BioTherapeutics and Bristol Myers Squibb Collaboration
On 9th April, Oxford BioTherapeutics announced a multi-year strategic collaboration with Bristol Myers Squibb to discover and develop next-generation T-cell engager therapies for solid tumours. The partnership will combine OBT’s proprietary OGAP®-Verify platform with BMS’s oncology expertise to identify tumour-selective targets and accelerate development of innovative immuno-oncology therapies.
MHRA Approves Olezarsen for Rare Genetic Condition
On 10th April, the MHRA approved olezarsen for adults with familial chylomicronaemia syndrome (FCS), a rare inherited condition that causes extremely high triglyceride levels and can lead to life-threatening pancreatitis. The treatment offers a new option for reducing triglycerides and lowering the risk of severe complications when used alongside a controlled low-fat diet.
MHRA and eBay Working In Partnership to Safeguard Public Health
On 13th April, the MHRA announced that its partnership with eBay had led to the removal of 215 listings for potentially dangerous and unauthorised erectile dysfunction medicines from the platform. The collaboration aims to tackle the illegal online sale of medicines, improve consumer safety, and strengthen public health protections through closer public-private cooperation.
Seizing the Opportunities of AI and Technology
On 15th April, the MHRA published a blog highlighting how the UK can harness AI and emerging technologies to improve healthcare, accelerate innovation, and support economic growth. The article emphasised the importance of strong regulation, robust evaluation, and ongoing monitoring to ensure AI technologies remain safe, effective, and equitable in real-world healthcare settings.
FDA Takes Step Forward on Testosterone Therapy for Men
On 16th April, the FDA announced it is encouraging manufacturers of approved testosterone replacement therapies (TRT) to explore a potential new indication for treating low libido in men with idiopathic hypogonadism. The move follows emerging clinical evidence suggesting TRT may be safe and effective for some men experiencing symptoms that significantly affect quality of life, while maintaining the FDA’s focus on rigorous safety and effectiveness standards.
EMA Recommends First Veterinary RNA-Based Vaccine
On 17th April, the EMA recommended authorisation of the first veterinary vaccine using RNA technology. The vaccine is designed to protect piglets against swine influenza and marks a significant step forward in applying RNA-based innovation within animal health, with potential benefits for disease prevention, animal welfare, and sustainable farming practices.
Precautionary Recall of Blood Pressure Medication After Manufacturing Error
On 20th April, the MHRA announced a precautionary recall of one batch of Ramipril 10mg capsules after a manufacturing error resulted in some packs containing lower-dose Ramipril 5mg capsules. The MHRA advised patients to check the batch number GR174091 and contact their pharmacist if the contents did not match the outer packaging.
Enflonsia Approved to Prevent RSV in Newborns and Infants
On 22nd April, the MHRA approved Enflonsia to help prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. The single-dose antibody treatment is designed to reduce the risk of serious lung infections, including bronchiolitis and pneumonia, in babies under 12 months old.
FDA Accelerates Action on Treatments for Serious Mental Illness
On 24th April, the FDA announced new measures to speed up the development of treatments for serious mental illness following a White House Executive Order. The agency introduced priority review vouchers and advanced clinical research pathways for psychedelic-based therapies targeting conditions such as treatment-resistant depression, PTSD, and substance use disorders, while emphasising the need for rigorous scientific and safety standards.
AstraZeneca and Northern Ireland Forge Strategic Partnership
On 24th April, AstraZeneca announced a first-of-its-kind strategic partnership with Northern Ireland’s Department of Health, Department for the Economy, and HIRANI to improve healthcare delivery and support life sciences innovation. The collaboration will focus on chronic disease management, digital health, and community-based care pathways to improve patient outcomes and strengthen Northern Ireland’s position as a centre for healthcare innovation.
EMA Recommends New Medicine for Familial Chylomicronaemia Syndrome
On 24th April, the EMA recommended approval of Redemplo to reduce triglyceride levels in adults with familial chylomicronaemia syndrome (FCS), a rare condition linked to severe pancreatitis risk. The RNA-based treatment significantly lowered triglyceride levels in clinical trials and offers a new option for patients whose condition is difficult to control through diet alone.
Precautionary Recall of Antidepressant Medication Due to Manufacturing Error
On 28th April, the MHRA announced a precautionary recall of one batch of sertraline 50mg tablets after a manufacturing error led to some packs containing the wrong medication. Patients were advised to check their packs and contact their pharmacist or healthcare professional if they had concerns or noticed anything unusual with their medication.
BioDuro and CTI Biotechnology Strategic Partnership
On 28th April, BioDuro announced a strategic partnership with CTI Biotechnology to accelerate preclinical drug development through an integrated platform spanning drug discovery to investigational new drug (IND) submission. The collaboration combines BioDuro’s discovery, DMPK, and manufacturing capabilities with CTI Biotechnology’s GLP toxicology and bioanalytical expertise to streamline workflows and help biotech and pharmaceutical companies advance innovative therapies more efficiently.
Seven Sentenced After MHRA Investigation into Illegal Medicines Network
On 29th April, the MHRA announced that seven men had been sentenced following an investigation into a £1.8 million illegal medicines and steroids network. The operation uncovered the large-scale supply of unlicensed medicines and performance-enhancing drugs, leading to more than 21 years of combined prison sentences and reinforcing the MHRA’s efforts to tackle unsafe medicines and protect public health.
Recommended Use of Some Nasal Decongestant Sprays Limited to Five Days in UK
On 30th April, the MHRA announced that nasal decongestant sprays containing xylometazoline and oxymetazoline should only be used for a maximum of five days due to risks linked to prolonged use, including rebound congestion and tissue damage. Updated packaging and patient leaflets will strengthen warnings and promote safer short-term use of these over-the-counter medicines.
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
On 1st May, the FDA announced expanded access for daraxonrasib, an investigational treatment for previously treated metastatic pancreatic cancer. The decision allows eligible patients to access the drug outside clinical trials through a compassionate use programme, following promising late-stage trial results that showed significantly improved survival compared with chemotherapy.
Operation Pangea XVIII Intercepts Millions of Dangerous Medicines
On 7th May, it was announced that more than two million doses of illicit medicines worth an estimated £4.6 million had been seized during Operation Pangea XVIII, a global crackdown on the illegal medicines trade. The two-week operation, carried out with UK Border Force and international partners, targeted dangerous and unauthorised medicines, disrupted online supply routes, and reinforced efforts to protect public health from criminal networks selling unsafe medicines.
UCB, Cancer Research UK and Cancer Research Horizons Strategic Alliance
On 7th May, UCB, Cancer Research UK, and Cancer Research Horizons announced a new multi-project strategic alliance to accelerate the development of novel cancer therapies. The collaboration expands an existing partnership and will combine UCB’s drug discovery expertise with Cancer Research UK’s clinical development capabilities to progress innovative oncology candidates from early research through to Phase 1/2 clinical trials.
25 Key Learnings from Exhibiting at GxP Conferences
As part of our 25 Years of Tower Mains series, we’re reflecting on another important area that has shaped our journey over the years… exhibiting at GxP conferences!
As our conference season gets underway, we’re connecting with quality professionals across the industry and hearing first-hand about the challenges, priorities, and opportunities shaping the GxP environment. Whether through conversations at our exhibition stand or insights shared during workshops, presentations, and panel sessions, clear themes continue to emerge.
In our latest blog, we share 25 key learnings from exhibiting at GxP conferences, highlighting how quality assurance is becoming increasingly strategic, cross-functional, and technology-driven. From integrated QA models and risk-based approaches to data integrity, digital tools, and inspection readiness, these insights reflect the evolving needs of the industry.
To read more, click here.
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