Company News
We’re delighted to be exhibiting at the 42nd Society of Quality Assurance Annual Meeting in National Harbor, Washington DC this month!
Bringing together over 800 QA professionals from around the world, the meeting will explore key hot topics including GCP, GLP, GMP, pharmacovigilance, scientific archiving, computer validation, veterinary medicine, and more.
Attending too? Stop by Booth 222 – our Head of Quality Assurance, Shona Ross, will be there and would love to chat.
If you’re planning to attend and would like to connect, feel free to reach out to us at info@towermains.com.
Regulatory Updates
EU Consults on Clinical Trial Rules for Health Emergencies
On 5th March, the European Commission, European Medicines Agency (EMA) and national medicines regulators launched a public consultation on new draft guidance for running clinical trials during public health emergencies. The guidance is intended to speed up the approval of new and ongoing trials during crises and is open for consultation until 30th April 2026.
FDA Meets With Several States on Lower-Cost Drug Imports
On 6th March, the FDA held talks with several states and tribes about plans to import lower-cost prescription drugs from Canada under the Section 804 Importation Program. The agency said it wants to make approvals easier while maintaining safety standards and has launched a new quality assurance tool to help states prepare proposals.
FDA Takes Further Steps to Cut Costs for Biosimilar Medicines
On 6th March, the FDA announced new draft guidance to streamline biosimilar development by reducing unnecessary clinical pharmacokinetic studies when there is enough scientific evidence. The agency said this could cut development costs by up to 50%, saving around $20 million per programme and helping lower the cost of biologic medicines for patients.
UK Health Data Resource Supports Thousands of Global Studies
On 10th March, a new paper highlighted the global impact of the UK’s Clinical Practice Research Datalink (CPRD), showing it has been used in 3,779 peer-reviewed studies across 29 countries since 1988. The research found that linked health records are increasingly helping to improve patient safety, guide healthcare policy and advance medical knowledge worldwide.
New Approval Process Could Speed Up Access to Medicines
On 10th March, the MHRA and NICE announced a new joint approval process that could allow patients in England to access some new medicines three to six months sooner. From 1 April, licensing and value assessments will run in parallel, helping reduce delays and giving companies clearer guidance during drug development.
FDA Launches New Adverse Event Reporting Tool
On 11th March, the FDA launched a new Adverse Event Monitoring System (AEMS) that allows the public to search reports of side effects and safety issues for drugs, vaccines, cosmetics and other regulated products through a single dashboard. The agency said the system will replace seven older databases, provide real-time reporting by the end of May 2026 and could save around $120 million over five years.
EMA Management Board Adopts 2025 Annual Report
On 13th March, the EMA Management Board adopted the agency’s 2025 annual report, highlighting work to improve medicines assessments, strengthen supply resilience and support faster patient access across the EU. The Board also reviewed progress on implementing electronic product information, the Health Technology Assessment Regulation, and measures to prevent medicine shortages.
FDA Issues Draft Guidance on Alternatives to Animal Testing
On 18th March, the FDA released draft guidance to help drug developers use non-animal methods such as computer models, lab-grown cells and organ-on-a-chip technology instead of animal testing in drug development. The agency said these New Approach Methodologies could help bring medicines to market faster, reduce costs and provide data that better reflects human biology.
EMA Launches New PRIME Tools to Speed Up Medicine Development
On 18th March, the EMA introduced three new features to its PRIME scheme to help developers of medicines for unmet medical needs get faster scientific advice and stay on track for approval. The new tools are designed to improve ongoing dialogue with regulators, speed up preparation for marketing applications, and help patients access innovative treatments sooner.
ICH Expands Quality Risk Management Training Materials
On 20th March, the International Council for Harmonisation (ICH) announced an updated and expanded Q9(R1) Quality Risk Management briefing pack to help regulators and industry better apply the revised guideline. The pack includes a new introductory presentation and nine training modules covering areas such as risk-based decision-making, subjectivity in risk assessments, product availability risks, and formality in quality risk management.
MHRA Supports Shift Away From Animal Testing
On 24th March, the MHRA announced new measures to help phase out animal testing in medicines development by supporting the use of non-animal methods such as AI analysis and human-derived cell models. Companies using these approaches will be able to receive early feedback on their data before applying for marketing approval, helping speed up the move towards more modern and ethical testing methods.
MHRA Publishes Internal Email on Pathways Trial
On 24th March, the MHRA published a copy of an internal email sent by Chief Executive Lawrence Tallon to staff about the paused Pathways clinical trial. The regulator said it was releasing the email for transparency and reiterated that patient safety and well-being remain its top priority.
MHRA Sets Out Approach to Reducing Animal Testing
On 25th March, the MHRA published new guidance on how medicine developers can use non-animal methods such as AI models, lab-grown human cells, and computer simulations in place of some animal testing. The regulator said these approaches can help speed up drug development while maintaining safety standards, although animal studies may still be needed in some cases.
MHRA Highlights Global Collaboration on Healthcare Innovation
On 25th March, the MHRA said international collaboration will be key to helping emerging technologies such as AI and advanced cell and gene therapies reach patients more quickly and safely. The regulator highlighted new work with Singapore’s Health Sciences Authority, including shared advice and pilot schemes designed to speed up approvals while maintaining safety standards.
EMA Publishes Outcome of Consultation on Real-World Data Quality Framework
On 28th March, the EMA published feedback from its public consultation on a draft framework for assessing the quality of real-world data used in medicines regulation. The framework is intended to help ensure data are fit for purpose, relevant to the research question and supported by robust systems and processes.
EMA Consults on Virtual Control Groups to Reduce Animal Testing
On 31st March, the EMA launched a consultation on using “virtual control groups” in preclinical studies to reduce the number of animals needed in medicines development. The approach would replace some live-animal control groups with data-driven “virtual animals”, while ensuring study results and human safety are not compromised.
EMA Considers Updating ALS Clinical Trial Guidance
On 31st March, the EMA published a concept paper on revising its guideline for clinical investigations of medicines for amyotrophic lateral sclerosis (ALS). The update aims to reflect advances in disease understanding, biomarkers, adaptive and platform trial designs, and emerging treatments, with a draft revised guideline expected in early 2027.
Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 18th March: Improving Patient Information. This project aims to make medicine information clearer, more accessible and easier for patients to trust and use. The initiative will collaborate with patient groups, charities, and healthcare professionals to identify barriers and modernise how information about medicines is provided.
- 20th March: Meningitis – Patient Factsheet. A new patient factsheet on meningitis was published, highlighting that the condition can develop quickly and may require urgent treatment. The guidance explains key symptoms such as fever, headache, stiff neck, and rash, and urges people to seek immediate medical help if meningitis or sepsis is suspected.
- 27th March: Clinical trials for medicines: guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom. Explains how the updated ICH E6(R3) Good Clinical Practice principles will be applied in UK clinical trial law from 28 April 2026. The guidance says sponsors and investigators must take a proportionate, risk-based approach to trial design and management, with a focus on participant safety, reliable data, and fit-for-purpose computer systems.
- 27th March: Clinical trials for medicines: guidance on quality and risk proportionality. Explains how clinical trial sponsors should apply quality-by-design and risk-based oversight when planning and running UK medicines trials. The guidance says researchers should focus on factors most critical to participant safety and reliable results, while avoiding unnecessary burden on participants and investigators.
- 30th March: Medical devices that need a clinical investigation. Aimed at helping manufacturers decide when a medical device needs a clinical investigation before it can be marketed. The guidance explains that non-UKCA or non-CE marked devices used on people will usually require MHRA notification, while studies involving already approved devices used within their intended purpose may not.
- 30th March: Clinical investigations: statistical considerations. On the statistical considerations needed for clinical investigations of medical devices. The guidance says studies should have clear objectives, appropriate sample sizes, and pre-defined analysis plans to ensure reliable evidence on device safety and performance. It also stresses the importance of accounting for all patients, documenting missing data and reporting serious adverse events to the regulator.
- 30th March: Clinical investigations: investigators’ responsibilities. Explains what information must be included when notifying the MHRA about a planned investigation, including approval processes, device labelling, conduct requirements and the documentation investigators need to provide.
- 30th March: Clinical investigations: biological safety assessments. New guidance has been published on biological safety assessments for medical devices used in clinical investigations. The guidance explains that manufacturers must provide scientific evidence showing that device materials are biologically compatible and safe for patients, considering factors such as toxicity, irritation, and long-term exposure risks.
- 30th March: Clinical investigations for electrically powered devices. For clinical investigations involving electrically powered medical devices. The guidance says applications should include details on electrical safety, electromagnetic compatibility, device specifications, risks and testing to show the device can be used safely in patients.
- 31st March: Approving clinical investigations. Explains how the MHRA decides whether to approve clinical investigations for medical devices. The regulator said it aims to process applications quickly while ensuring risks to patients and users are minimised and that any investigation is justified by the potential benefits.
- 31st March: Clinical investigations: compiling a submission. To help manufacturers prepare submissions for medical device clinical investigations. The guidance explains what documents and supporting information must be included, how applications should be submitted through IRAS, and the different rules that apply in Great Britain and Northern Ireland.
- 31st March: Clinical investigations in Great Britain. Explains how manufacturers should run clinical investigations for medical devices in Great Britain. The guidance explains when investigations are required, how to notify the MHRA, and the need to demonstrate that devices are safe, perform as intended and have an acceptable balance of benefits and risks. It also says manufacturers must usually give the MHRA 60 days’ notice before starting an investigation.
- 31st March: Clinical investigations in Northern Ireland. Explains how clinical investigations for medical devices should be carried out in Northern Ireland. The guidance says studies in Northern Ireland must follow EU medical device rules, and that a single application to the MHRA can cover both Northern Ireland and Great Britain sites if it is submitted under the EU framework.
- 1st April: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway. Information on the new aligned pathway launched by the MHRA and National Institute for Health and Care Excellence (NICE). Designed to help NHS patients in England access some new medicines three to six months sooner, and allows licensing and value assessments to happen in parallel, while a new Integrated Scientific Advice service will give companies earlier guidance on evidence requirements and reduce delays in development.
US Food & Drug Administration (FDA) – Draft Guidances
- 6th March: Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection. To assist manufacturers who choose to respond to the FDA when they receive an FDA Form 483 Inspectional Observations (FDA 483) at the conclusion of a drug inspection to assess conformity with current good manufacturing practice (CGMP) requirements.
- 6th March: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4). Provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
- 18th March: General Considerations for the Use of New Approach Methodologies in Drug Development. Provides drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development.
Updated Guidance
MHRA
- 6th March: COVID-19 test approval: how to apply. Introduced the CTDA accelerated pathway and updated desktop review guidance.
- 6th March: MHRA phase I accreditation scheme. The latest list of Phase I accredited organisations/units was added.
- 9th March: MHRA phase I accreditation scheme. Wording updated to align with current guidance on clinical trials that include an IVD.
- 16th March: Get more help to apply for medicines, Integrated Scientific Advice (ISA). Changes made to Scientific Advice (ISA) service application questions
- 24th March: Medicines: Get integrated scientific advice from the MHRA and NICE. A new version of the ‘eligibility check & application submitted’ table under ‘Timings’ was added.
- 24th March: Innovative Licensing and Access Pathway (ILAP). Updated ‘ILAP metrics’ document with quarterly update and added extra sections to ‘What’s on Offer in ILAP’ document.
- 31st March: Clinical trials for medicines: apply for authorisation in the UK. Removed outdated text in the section ‘Assessment of your submission’ and deleted the section ‘Combined review of clinical trials of an investigational medicinal product.’ The section ‘Applications that need expert advice’ was also updated to reflect the change to the timeline from 14 days to 28 days.
- 1st April: Certificate of Free Sale for exporting medical devices. Updated Certificates of Free Sale Reference Guide.
EMA
- 28th March: Changing the (invented) name of a centrally authorised medicine. The EMA has updated its guidance on changing the invented name of a centrally authorised medicine, confirming that companies can make the change through a Type IAIN variation once the proposed new name has been approved by the EMA’s Name Review Group.
FDA – Final Guidances
- 3rd 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.
- 6th March: Questions and Answers on Biosimilar Development and the BPCI Act. Provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar products, as well as describe the FDA’s interpretation of certain statutory requirements added by the BPCI Act.
- 13th March: Medical Devices with Indications Associated with Weight Loss – Premarket Considerations. Provides the FDA’s recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions (e.g., Premarket Approval (PMA) Applications, Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo classification requests).
- 17th March: Physicochemical and Structural (Q3) Characterisation of Topical Drug Products Submitted in ANDAs. Intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes.
- 18th March: Pyrogen and Endotoxins Testing: Questions and Answers. Provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> “Bacterial Endotoxins Test”, USP Chapter <161> “Medical Devices ‒ Bacterial Endotoxin and Pyrogen Tests”, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72).
- 30th March: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle. Provides recommendations on when and what methods to use to collect and submit patient preference information (PPI) for a device to the FDA. This guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit PPI to aid in FDA-decision making across the total product life cycle.
Industry News
Blood Pressure Medication Recall Over Packaging Error
On 6th March, Crescent Pharma recalled one batch of Ramipril 5mg capsules after some packs were found to contain Amlodipine tablets instead due to a packaging mix-up. Patients with batch number GR164099 should check the blister strips inside their pack and contact their pharmacist if they are labelled ‘Amlodipine’.
Kainova Therapeutics Reports Positive Phase I Results for DT-9081
On 10th March, Kainova Therapeutics announced positive topline results from its Phase I EPRAD study of DT-9081, an oral EP4 receptor antagonist for advanced solid tumours. The study showed a favourable safety profile, sustained target engagement, and early signs of anti-tumour activity.
FDA Approves First Treatment for Cerebral Folate Transport Deficiency
On 10th March, the FDA approved Wellcovorin as the first treatment for adults and children with cerebral folate transport deficiency caused by a confirmed FOLR1 gene variant. The rare condition can cause developmental delays, seizures and movement disorders, and the approval was based on published case reports and other real-world evidence.
MHRA Approves New Treatment for Severe Alopecia Areata
On 12th March, the MHRA approved deuruxolitinib, marketed as Leqselvi, to treat adults with severe alopecia areata. Clinical trials found the medicine helped many patients regrow hair, with around 30% achieving 80% or more scalp coverage after 24 weeks of treatment.
Reclassifying Medicines Could Save NHS £1.4bn
On 12th March, the MHRA highlighted that expanding the reclassification of medicines from prescription-only to pharmacy or over-the-counter status could save the NHS up to £1.4 billion a year. The move could also improve access to treatments, reduce pressure on GPs and pharmacies, and support greater self-care for conditions such as pain, skin problems, and women’s health.
Hibiwash Recall Issued Over Possible Contamination
On 12th March, Mölnlycke Health Care recalled three batches of Hibiwash antimicrobial wash after possible contamination with Burkholderia cepacia was identified at its manufacturing facility. Patients with batch numbers 5156042, 5156043 or 5156093 are being advised to stop using the product and return it to a pharmacy, although no cases of harm have been reported.
DNA Script Expands Access to On-Demand DNA Synthesis
On 17th March, DNA Script announced new distributor agreements across Latin America, Japan, and South Korea to expand access to its SYNTAX on-demand DNA synthesis platform. The company said the partnerships will help researchers access high-quality ssDNA oligonucleotides more quickly and reduce reliance on overseas suppliers.
R1 Therapeutics Launches With $77.5 Million Series A Financing
On 17th March, R1 Therapeutics launched with an oversubscribed $77.5 million Series A financing to support the development of AP306, a first-in-class treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis. The company also secured exclusive rights outside Greater China to develop and commercialise AP306, with a Phase IIb study planned for later this year.
Samsung Bioepis and Sandoz Expand Biosimilars Partnership
On 18th March, Samsung Bioepis and Sandoz announced a new agreement covering up to five next-generation biosimilar candidates, including SB36, a biosimilar version of Entyvio. Under the deal, Samsung Bioepis will lead development and manufacturing, while Sandoz will commercialise the products globally outside selected Asian markets.
FDA Approves First Treatment for Neurologic Hunter Syndrome
On 25th March, the FDA approved Avlayah as the first treatment for the neurologic manifestations of Hunter syndrome in children. The weekly infusion is designed to cross the blood-brain barrier and could help address cognitive and behavioural symptoms that existing treatments do not target.
EMA Recommends Imdylltra for Relapsed Small Cell Lung Cancer
On 27th March, the EMA recommended approving Imdylltra for adults with extensive-stage small cell lung cancer whose disease has returned after platinum-based chemotherapy. The treatment is aimed at patients with limited options and poor prognosis and works by helping the immune system target cancer cells.
Rocket Pharmaceuticals Wins FDA Approval for First LAD-I Gene Therapy
On 27th March, Rocket Pharmaceuticals announced FDA approval of Kresladi, the first treatment for severe leukocyte adhesion deficiency-I (LAD-I), a rare and often fatal immune disorder in children. The one-time gene therapy was approved based on trial data showing 100% survival at 12 months after treatment, and Rocket plans a phased launch through specialist centres later in 2026.
Almirall Partners With Huaota on New Dermatology Antibody
On 27th March, Almirall announced a collaboration and licensing agreement with Huaota Biopharmaceutical to develop a novel monoclonal antibody for medical dermatology and other indications. Huaota will lead early research and initial clinical development in China, while Almirall will hold global rights outside China under a deal worth up to $340 million in upfront payments, milestones, and royalties.
25 Common Data Integrity Findings
As part of our 25 Years of Tower Mains series, we’re taking a closer look at a topic that continues to surface time and time again… data integrity!
Data integrity is often framed in terms of systems, controls, and regulations. In reality, it’s about people, culture, and how day-to-day processes are conducted. From paper records and handwritten logbooks to cloud-based systems, AI, and digital platforms, the way companies manage data has transformed over the last 25 years. Yet despite all the change, data integrity findings continue to be one of the most common issues raised during inspections.
In our latest blog, we share 25 common data integrity findings across GLP, GCP, GMP, and PV in clinical trials that have led to regulatory inspections or review issues, highlighting recurring challenges across people, processes, and systems.
To read more, click here.
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