Company News
12th Annual Outsourcing in Clinical Trials UK & Ireland
We’re thrilled to announce that Tower Mains will be exhibiting at the 12th Annual Outsourcing in Clinical Trials UK & Ireland in London next week!
If you’re attending, be sure to stop by and say hello – Lianne Roeling and Rhona McAteer will be on hand to discuss how we can support you and your organisation.
For more information on the event, click here.
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. 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.
Regulatory News
FDA to Expand Use of Unannounced Inspections at Overseas Facilities
On 6th May, the FDA announced plans to broaden the use of unannounced inspections at foreign manufacturing sites that produce food, essential medicines, and medical products intended for the US market. This expansion builds on the agency’s existing pilot program in India and China and aims to ensure foreign manufacturers are held to the same regulatory standards as domestic ones.
EMA and HMA Outline Data and AI Strategy for Medicines Regulation
On 7th May, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published a joint workplan “Data and AI in medicines regulation to 2028”. The plan details how the European regulatory network intends to harness large-scale health data and AI tools to drive innovation, support regulatory decisions, and accelerate patient access to better treatments.
FDA Concludes First AI-Assisted Review Pilot, Sets Aggressive AI Rollout Plan
On 8th May, the FDA announced the successful completion of its first generative AI pilot for scientific review and revealed a fast-tracked plan to expand AI implementation across all FDA centres by June 20th, 2025. These tools aim to streamline internal workflows by automating repetitive tasks, allowing staff to focus on critical scientific evaluations.
HHS and FDA Launch Deregulation Initiative to Reduce Costs
On 13th May, the US Department of Health and Human Services (HHS) and the FDA issued a public Request for Information (RFI) to gather input on eliminating outdated or unnecessary regulations. This effort is part of a wider deregulatory initiative aligned with President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation.”
MHRA Explains Validity of UK GMP and GDP Certificates
On 16th May, the MHRA Inspectorate published guidance on how it determines the validity periods for UK-issued Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates.
MHRA Holds First Board Meeting in Scotland, Emphasising Regional Commitment
On 21st May, the MHRA Board convened in Scotland for the first time, signalling its dedication to health equity and innovation across all UK regions.
MHRA Marks International Clinical Trials Day with Progress Update
On 20th May, the MHRA highlighted the major progress that has been made in delivering a more efficient and adaptable regulatory framework for clinical trials
MHRA launches consultation on the Use of External Control Arms Based on Real-World Data to Support Regulatory Decisions
On 20th May, the MHRA launched a consultation on a draft guidance on the use of external control arms based on real-world data to support regulatory decisions. The draft guideline provides clinical trial sponsors with points to consider and key principles that should be considered when planning a clinical trial which will include a real-world data (RWD) external control arm (ECA), and which will require regulatory approval. The 6-week consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of this guideline, including any perceived contradictions or omissions.
MHRA Focuses on Aseptic Operations in “Specials” Manufacturing
On 22nd May, the MHRA Inspectorate released commentary on its letter to holders of Manufacturers’ “Specials” Licences regarding the production of sterile products. The communication emphasises strict controls on aseptic processing and sanitisation practices.
FDA Addresses Data Integrity Issues at Chinese Testing Labs
On 22nd May, the FDA’s Centre for Devices and Radiological Health (CDRH) sent General Correspondence Letters to two Chinese third-party testing labs after identifying falsified or unreliable data. This move forms part of broader efforts to uphold data integrity in global medical device testing.
EMA Begins Review of Ipidacrine-Based Medicines
On 23rd May, the EMA’s Committee for Medicinal Products for Human Use (CHMP) initiated a review of ipidacrine-containing medications, which are used in several EU countries to treat neurological conditions.
MHRA Issues May 2025 Safety Update
On 29th May, the MHRA published its monthly safety update, summarising the latest guidance and alerts for users of medicines and medical devices.
FDA Launches Elsa: AI Tool to Enhance Operational Efficiency
On 2nd June, the FDA rolled out Elsa, a generative AI platform designed to streamline tasks across the agency. From scientific reviewers to field investigators, the tool is intended to boost productivity and modernise internal processes for better service delivery to the public.
Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 16th May: Manufacturer’s Online Reporting Environment (MORE). The MHRA issued information on the Manufacturer’s Online Reporting Environment (MORE), a digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents
- 16th May: MORE implementation. Guidance was published on the updates to reporting forms following the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
European Medicines Agency (EMA)
- 2nd June: Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations. An overview of comments received on ‘Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations’ (EMA/CVMP/55240/2025) was published.
- 3rd June: Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) – Revision 2. The second revision of the guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) was published. It updates the guideline to be consistent, where applicable, with the revised guideline for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94033/2007 current version).
US Food & Drug Administration (FDA)
- 29th May: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The FDA issued final guidance to provide an overview of the mechanisms available to submitters through which they can request interactions with the Food and Drug Administration (FDA) related to medical device submissions.
Updated Guidance
MHRA
- 9th May: The Northern Ireland MHRA Authorised Route (NIMAR). The MHRA updated guidance for key stakeholders in the medicines supply chain to facilitate their use of the NIMAR regulatory route for the continued supply of GB-licensed medicines to NI.
- 12th May: Medicines: apply for a parallel import licence. The section on Tell and Do (TaD) variations was updated.
- 13th May: International Recognition Procedure. An updated validation checklist form was added to the guidance on using the International Recognition procedure for medicines licensing applications.
- 16th May: Medicines: reclassify your product. Updated the ‘Table of approved reclassifications’ and ‘Flow diagram for national major reclassification applications’.
- 16th May: National assessment procedure for medicines. A link was published to the MHRA licensing webinar.
- 30th May: Innovative Licensing and Access Pathway (ILAP). ‘ILAP Data Protection and Privacy Information’ was added to the guidance on the Innovative Licensing and Access Pathway (ILAP), a unique initiative which aims to accelerate the time to patient care for transformative new medicines and drug-device combinations.
- 4th June: RegulatoryConnect. The 2024 RegulatoryConnect webinars were removed, and the RegulatoryConnect 22 May 2025 webinar recording was added.
FDA
- 5th May: Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Draft guidance was issued to assist establishments making donor eligibility (DE) determinations in understanding the requirements in 21 CFR part 1271, subpart C (21 CFR part 1271, subpart C). The regulations under 21 CFR part 1271, subpart C, set out requirements for determining donor eligibility, including donor screening and testing, for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
- 29th May: Replacing Colour Additives in Approved or Marketed Drug Products. Draft guidance was provided with recommendations for replacing colour additives in approved or marketed drug products. If a colour additive is replaced in a drug product, information to support the change should be retained and available at the manufacturing facility. Additionally, this draft guidance recommends that new drug application (NDA) and abbreviated new drug application (ANDA) holders submit information to support colour additive replacements in changes being effected in 30-day (CBE-30) supplements.
- 29th May: Electronic Submission Template for Medical Device Q-Submissions. Draft guidance was published to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-Subs), to the Centre for Devices and Radiological Health and the Centre for Biologics Evaluation and Research to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to the FDA.
- 30th May: M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver. The FDA announced the availability of a draft guidance aimed at providing harmonised criteria and data that support waivers for drug applications with multiple strengths when in vivo BE has been demonstrated for at least one strength using the principles outlined in the final guidance “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” published in October 2024.
Industry News
Spotlight on Women Driving Safe Development of Digital Mental Health Tools
To mark Mental Health Awareness Week, the MHRA shared the stories of two women, each with personal experiences of mental health challenges, who are working together to ensure that digital mental health technologies (DMHTs), including those using AI, are developed with safety, effectiveness, and user needs at the forefront.
EMA Confirms Suicidal Thoughts as Side Effect of Finasteride
On 8th May, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a review confirming that suicidal ideation should be listed as a side effect of finasteride (1 mg and 5 mg tablets). Although the frequency remains unknown, the benefits of finasteride and dutasteride for approved indications still outweigh the associated risks.
MHRA Approves First Low-Carbon COPD Inhaler
On 12th May, the MHRA approved a low-carbon version of the COPD treatment Trixeo Aerosphere, featuring a new environmentally friendly propellant (HFO-1234ze(E)). The updated inhaler maintains the same safety and efficacy profile as the original product.
Apiary Capital Invests in Digital Pharma Marketing Firm Performance.io
On 12th May, Apiary Capital announced a major investment in performance.io (PIO), a digital performance marketing specialist for the pharmaceutical sector. The funding will support PIO’s expansion across the US and Asia and drive growth through recruitment and tech development.
MHRA Approves Capvaxive Vaccine for Pneumococcal Disease
On 15th May, the MHRA authorised Capvaxive, a vaccine developed to protect adults aged 18 and older against infections caused by Streptococcus pneumoniae.
Thiopurine Use Linked to Intrahepatic Cholestasis of Pregnancy
On 15th May, the MHRA reported rare cases of intrahepatic cholestasis of pregnancy (ICP) in patients treated with azathioprine and similar thiopurine drugs. Drug-induced cholestasis appears to occur earlier in pregnancy and may not respond to standard treatments like ursodeoxycholic acid.
EU Temporarily Limits Chikungunya Vaccine Use in Older Patients
On 16th May, the European Commission announced it has adopted a temporary restriction on the use of the Chikungunya vaccine (IXCHIQ) in individuals aged 65 and older, following an EMA safety committee (PRAC) recommendation. The measure comes after reports of serious adverse effects in this age group.
EMA ETF Recommends COVID-19 Vaccine Update for 2025/26 Season
On 16th May, the EMA’s Emergency Task Force (ETF) recommended updating COVID-19 vaccines to target the emerging SARS-CoV-2 LP.8.1 variant. The recommendation follows consultations with WHO, global regulators, and vaccine manufacturers, based on virological and preclinical data.
MHRA Expands Approval of Guselkumab to Include IBD
On 18th May, the MHRA approved guselkumab (Tremfya) for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adults unresponsive to other therapies. The drug was previously approved for plaque psoriasis and psoriatic arthritis.
Sonrai and AOA Dx Partner to Accelerate Ovarian Cancer Test Development
On 20th May, AI precision medicine firm Sonrai Analytics and biotech company AOA Dx announced a partnership to accelerate the development of a liquid biopsy test for early ovarian cancer detection. The collaboration focuses on validating a multi-omic biomarker strategy to support the diagnostic platform.
FDA Expands Pathway for State Drug Importation Programs
On 21st May, the FDA announced updates to its framework under Section 804 of the Federal Food, Drug, and Cosmetic Act, enabling U.S. states and tribal authorities to import select prescription drugs from Canada. The initiative is aimed at reducing drug costs while maintaining public health safeguards.
EMA Recommends Changes to Azithromycin Use
On 23rd May, the EMA’s CHMP proposed changes to azithromycin’s approved uses in the EU, including the removal of certain indications. The revisions aim to ensure responsible use and curb the development of antimicrobial resistance.
Inspection Readiness: Are you prepared?
Inspections by regulatory authorities can have significant implications – failing one can lead to penalties, reputational damage, and the potential suspensions of operations, whilst a successful inspection can bolster confidence and assure the quality and safety of your products or services.
Whether your inspection is looming or far away, prioritising preparation and proactive compliance are key to maintaining integrity and meeting regulatory expectations, and this means having the necessary systems, processes, and documentation in place.
At Tower Mains, we understand the complexity and challenges associated with regulatory inspections and have compiled some top tips on how you can achieve inspection readiness.
Issue Number: WN00198
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