Company News

We are thrilled to announce that our Head of Quality Assurance, Shona Ross, and Head of Operations, Lianne Roeling, will be heading to Orlando, Florida for the upcoming Society of Quality Assurance 41st Annual Meeting.

Shona will also be leading a quick session on Wednesday morning on why we need to think about going back to basics in our approach to regulations.

Will you be there too? Drop us a line at info@towermains.com. We’d love to chat.

Regulatory News

EU Launches New Clinical Trial Map for Patients and Healthcare Professionals
On 3rd March, the European Medicines Agency (EMA) unveiled a new clinical trial map on the Clinical Trials Information System (CTIS) designed to help patients and healthcare professionals easily find ongoing trials in their region. The map enables users to search by location and medical condition, offering contact information for investigators and improving access to clinical research. This initiative is a key part of the EU’s “Accelerating Clinical Trials” plan, aimed at boosting transparency and fostering greater patient engagement in clinical trials across Europe.
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MHRA Publishes Government Response Consultation on Fee Changes
On 6th March, the MHRA published the government’s response to its consultation on proposed amendments to its statutory fees to ensure ongoing cost recovery. The proposals included increasing medical product and service fees, amending the Medical Device Registration fee to cover post-market activities, and introducing a new service for regulatory advice.
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EMA Issues Warning on Health Risks from Unregulated Advanced Therapy Medicinal Products
On 13th March, the EMA and the Heads of Medicines Agencies (HMA) issued a warning about the dangers of unregulated advanced therapy medicinal products (ATMPs), including dendritic cell cancer therapies, being marketed directly to patients. These products lack proper oversight and can cause serious side effects while offering no proven benefits. The EMA stresses that only ATMPs authorised by regulatory authorities should be used and encourages patients to verify treatments through official sources.
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Rui Santos Ivo Elected New Chair of EMA Management Board
On 13th March, Rui Santos Ivo was elected as the new chair of the European Medicines Agency (EMA) Management Board for a three-year term, succeeding Lorraine Nolan. With extensive experience in medicine regulation, Santos Ivo is also the president of the Portuguese National Authority of Medicines (Infarmed). He highlighted the vital role of EMA’s leadership in maintaining health standards amid evolving regulatory challenges.
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FDA Issues Letter on Hemodialysis Bloodline Shortage
On 14th March, the FDA issued a letter to health care providers regarding ongoing interruptions in the supply of hemodialysis bloodlines due to recent supplier issues. This shortage, which has been added to the FDA’s medical device shortage list, is expected to impact patient care, particularly for those requiring acute or chronic hemodialysis, and may continue through early fall 2025.
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EMA and EU Medicines Agencies Set Strategy for 2028
On 18th March, the EMA and HMA unveiled a joint strategy to guide the EU medicines regulatory network through 2028. The updated plan focuses on addressing emerging public health challenges, such as antimicrobial resistance and innovations like artificial intelligence. It aims to improve accessibility, competitiveness, and sustainability in the EU healthcare sector while promoting a “One Health Approach” that links human, animal, and environmental health.
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EMA Releases Interim Report on Pilot Program for High-Risk Medical Device Manufacturers
On 24th March, the EMA published an interim report on a pilot launched in February 2023 offering expert advice to manufacturers of high-risk medical devices regarding clinical development strategies and investigations. The report outlines the advice process, feedback, and results from 20 finalised applications by the end of 2024, with the full procedure set for broader implementation in February 2025.
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MHRA Launches Monthly Safety Bulletin and Redesigned Alerts
On 25th March, the MHRA launched the “MHRA Safety Roundup,” a new monthly safety bulletin designed to provide healthcare professionals with a summary of safety updates for medicines, medical devices, and healthcare products. This initiative is part of the MHRA’s strategy to improve safety communications, and the bulletin will include drug safety updates, device information, recalls, and important alerts.
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MHRA Unveils Next Phase of Regulatory Science to Speed Up Access to Innovative Treatments
Last week, the MHRA hosted an event in Westminster to highlight the work of the seven newly established Centres of Excellence for Regulatory Science and Innovation (CERSIs). The event brought together MHRA, Innovate UK, the Office for Life Sciences, and the Medical Research Council (MRC), along with government, industry, and academic representatives. CERSI leads presented updates on their projects, demonstrating how these initiatives will drive advancements in healthcare.
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Update on MedEthicsEU Report: Survey on National Clinical Trial Application Requirements
On 28th March, the European Commission published an update on the MedEthicsEU report, focusing on a survey examining the national Part II Clinical Trial Application (CTA) requirements. The report provides insights into the varying national practices for clinical trial applications across the EU and aims to enhance the understanding of regulatory harmonisation and promote better collaboration between member states in clinical trial processes.
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Lawrence Tallon Begins Role as New MHRA CEO
On 1st April, Lawrence Tallon officially started his tenure as Chief Executive Officer of the MHRA. With a strong focus on patient safety, innovation, and global partnerships, Tallon aims to improve access to new medicines and medical devices. He succeeds Dr June Raine, who retired after leading the agency through critical challenges, such as the COVID-19 pandemic and the UK’s exit from the EU.
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Published Guidance

Medicines and Healthcare products Regulatory Agency (MHRA)

  • 19th March: Decentralised manufacture hub. The MHRA released information on the new regulations for the decentralised manufacture (DM) of medicines, including point-of-care (POC) and modular manufacturing (MM), which will take effect on 23 July 2025. These regulations aim to enable the production of medicines closer to patients, addressing challenges compared to traditional manufacturing.
  • 25th March: Safety communications concerning medicines, medical devices and other healthcare products. Guidance was issued to inform healthcare professionals and the public about potential risks and new safety issues regarding medicines, medical devices, and healthcare products. These communications include updated advice, risk mitigations, and actions such as product withdrawals or regulatory changes to ensure patient safety.

European Commission

European Medicines Agency (EMA)

Updated Guidance

MHRA

US Food and Drug Administration (FDA)

  • 24th March: Data Standards Catalog. The FDA updated its Data Standards Catalog (Catalog), which lists the data standards and terminologies that the FDA supports for use in regulatory submissions to better enable the evaluation of the safety, effectiveness, and quality of FDA-regulated products.
  • 27th March: Study Data Technical Conformance Guide – Technical Specifications Document. The FDA finalised guidance that provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardised electronic format in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs)
  • 31st March: Evaluation of Sex-Specific Data in Medical Device Clinical Studies. The guidance on studying and evaluating sex-specific data in medical device clinical studies has been finalised. Its purpose is to outline the FDA’s expectations for patient enrollment based on sex, as well as the analysis and reporting of sex-specific data in study results.

Industry News

MHRA Collaboration Cuts Infection Diagnosis Time
A new study highlights the success of the MHRA’s collaboration with Barts Health NHS Trust, using DNA sequencing to speed up infection diagnoses. Using onsite DNA sequencing, the technology provides results in just two days, compared to traditional methods that can take up to a week or longer. This faster diagnosis allows for more accurate treatment, helping patients recover quicker and reducing the risk of complications, including antibiotic-resistant “superbugs.”
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Removal of Post-Operative Pain Indication for Prolonged-Release Opioids
On 12th March, the MHRA announced that the indication for the treatment of post-operative pain has been removed from the licences of all prolonged-release opioids due to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).
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FDA Publishes Case Studies to Support Rare Disease Drug Development
On 13th March, the FDA’s Center for Drug Evaluation and Research (CDER) released two case studies and a user guide as part of the Accelerating Rare Disease Cures (ARC) Program’s LEADER 3D initiative. The case studies highlight successful approaches used by sponsors in rare disease drug development.
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EMA Recommends Approval of First Vaccine Against Epizootic Haemorrhagic Disease
On 14th March, the EMA recommended the approval of Hepizovac, the first vaccine developed for cattle against epizootic haemorrhagic disease (EHD). The vaccine targets EHDV serotype 8, which has caused recent outbreaks in Europe. Clinical trials have shown strong efficacy, offering protection against the disease, which can lead to severe symptoms or death in cattle. The recommendation for approval was made under exceptional circumstances due to the urgent need to control the disease and protect animal health and agriculture.
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EMA Approves First AI Tool for Diagnosing Inflammatory Liver Disease
On 20th March, the EMA approved AIM-NASH, the first artificial intelligence (AI) tool designed to diagnose metabolic dysfunction-associated steatohepatitis (MASH) in liver biopsy samples. The tool aims to improve the accuracy and consistency of diagnosing liver inflammation and fibrosis, reducing variability in clinical trials for MASH treatments. Trained on over 100,000 biopsy annotations, AIM-NASH provides reliable, reproducible results, supporting faster and clearer evidence for new treatments.
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FDA Issues Early Alert for CVAC Aspiration System Issue
On 20th March, the FDA issued an early alert regarding a safety issue with the CVAC Aspiration System from Calyxo, which may pose significant risks to patients. The system, used in urological procedures for treating urinary stones, has been linked to a fatal incident caused by excessive kidney pressure due to thick fluid in the kidney. The FDA advises healthcare providers to adhere to updated guidelines, including stopping fluid inflow if outflow is slow or absent and refraining from using the system if fluid visibility is blocked.
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New Discovery on Adaptive Defences Against Jumping Genes
On 21st March, researchers from the University of Tokyo, led by Professor Kiyoshi Shimada and Dr. Hiroshi Kubo, unveiled how cells defend against “jumping genes” (transposons) that can cause harmful mutations. The team discovered that piRNAs (PIWI-interacting RNAs) are crucial for silencing these genes, with their production being enhanced by the “ping-pong cycle.” This cycle amplifies piRNA and adapts to different jumping genes, ensuring continued suppression. The findings, observed in silkworms, flies, and mice, could pave the way for advancements in medical diagnostics and treatments for conditions like male infertility linked to piRNA malfunctions.
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Sebetralstat for Treating Hereditary Angioedema (HAE) Attacks
On 24th March, the MHRA issued a scientific opinion on the use of Sebetralstat for treating hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. The opinion is part of the Early Access to Medicines Scheme (EAMS), providing detailed protocols for healthcare professionals, patients, and pharmacovigilance systems. This includes a public assessment report and treatment guidelines for effective use.
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Rxulti Approved in the EU for Adolescent Schizophrenia Treatment
On 24th March, Lundbeck and Otsuka Pharmaceutical revealed that the European Commission has approved Rxulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 and older. This approval builds upon its earlier use in adults with schizophrenia. Clinical trials showed that brexpiprazole notably reduces schizophrenia symptoms in adolescents compared to a placebo.
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Dame June Raine Reflects on Innovations Transforming Healthcare Regulation
As Dame June Raine prepares to step down after nearly 40 years at the agency, including the last five as CEO, she reflects on how innovations are reshaping regulation and expresses her gratitude for the opportunity to work alongside inspiring individuals during a transformative period that she has not only witnessed but also played a key role in shaping.
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UKHSA Identifies Key Pathogens at Greatest Risk to Public Health
On 25th March, the UK Health Security Agency (UKHSA) released a new reference tool highlighting 24 pathogen families with the greatest potential public health risks. The list aims to prioritise research into diagnostics, vaccines, and treatments and focuses on pathogens that pose potential threats due to factors like climate change and antimicrobial resistance.
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FDA Monitors Issues with Essure Birth Control Device
On 26th March, the FDA announced that it remains committed to monitoring reports of problems with Essure, a permanent birth control device removed from the market in 2019. Since its approval, over 73,000 adverse event reports have been received, including pain, device migration, and complications requiring removal.
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MHRA Approves Trofolastat for Prostate Cancer Imaging
On 28th March, the MHRA announced the approval of Trofolastat (RoTecPSMA) for the diagnostic imaging of prostate cancer in men. This groundbreaking product combines a PSMA-targeting agent with a radioactive tracer, enabling effective detection of prostate cancer using SPECT imaging. It will help identify cancer spread, recurrence, and assess treatment outcomes. Clinical trials showed a 94.2% sensitivity in detecting the disease.
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FDA Approves Qfitlia for Haemophilia A and B
On 28th March, the FDA approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years of age and older with haemophilia A or haemophilia B, with or without factor VIII or IX inhibitors. Clinical trials demonstrated a significant reduction in bleeding rates, but the treatment carries risks of blood clotting and liver toxicity.
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FDA Approves First At-Home Test for Chlamydia, Gonorrhea, and Trichomoniasis
On 28th March, the FDA approved the first-ever at-home test for chlamydia, gonorrhea, and trichomoniasis developed by Visby Medical. The test, designed for women, provides results within 30 minutes and can be used with or without symptoms. It uses a self-collected vaginal swab and connects to a mobile app to deliver results. This approval aims to improve access to sexual health testing, enabling quicker diagnoses and treatments while helping to reduce the spread of these infections.
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First EU-Wide Report on Antimicrobial Use and Sales in Animals
On 31st March, the EMA released the first EU-wide report on the sales and use of antimicrobials in animals. Covering data from all 27 EU member states, along with Iceland and Norway, the report presents figures for 2023. It reveals that 98% of veterinary antibiotic sales were for food-producing animals, with penicillin being the most sold class. The report also highlights ongoing efforts to improve data collection across four main animal species and emphasises the importance of tackling antimicrobial resistance through responsible use.
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New Course Alert: ICH Good Clinical Practice (GCP) E6 (R3)

We are delighted to introduce our new ICH Good Clinical Practice (GCP) E6 (R3) course.

If you are involved in clinical research or clinical trials, this course is designed to help you stay ahead of the curve. It provides comprehensive knowledge of the updated ICH GCP E6 (R3) regulations, ensuring you understand the latest developments and their implications for your role in clinical trials.

Throughout the course, you’ll:

  • Dive deep into the updated ICH GCP E6 (R3) regulations, focusing on the changes and their impact.
  • Explore the background, scope, and applications of ICH E6 (R3).
  • Examine how ICH E6 (R3) aligns with ICH E8 (R1).
  • Build confidence in applying updated principles that affect trial design and conduct.
  • Understand the roles and responsibilities of Ethics, Sponsors, and Investigators.
  • Gain insights into the increased emphasis on risk proportionality and Quality by Design.

Upon completion of the course, you will have a clear understanding of the end-to-end clinical drug testing process, including risk management and the considerations in the identification of critical to quality factors and quality by design.

We offer flexible training options, available for individuals or groups, allowing you to schedule your training at your convenience.

If you’re interested, please reach out to us at training@towermains.com or click here for more information.

Issue Number: WN00196

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