Company News
We’re delighted to announce that Nicole and Shona will be taking part in the RQA Virtual Symposia next week.
Held on 8th and 9th September, the event will feature two dedicated virtual symposia focused on QA Careers and QA Leadership.
Regulatory News
EMA Publishes PRAC Recommendations on Safety Signals
On 3rd August, the European Medicines Agency (EMA) published an overview of the safety signals reviewed by the Pharmacovigilance Risk Assessment Committee (PRAC) during its 6-9 July 2026 meeting. The document outlines the Committee’s recommendations and includes the relevant EPITT reference numbers for each signal reviewed.
MHRA Advises Quarantine of Non-Compliant Medical Devices
On 10th August, the Medicines and Healthcare products Regulatory Agency (MHRA) advised healthcare organisations to remove from use and quarantine medical devices supplied without valid UKCA or CE conformity markings or certification. The alert aims to ensure that only devices meeting the required regulatory requirements remain in use.
MHRA Reaffirms Confidence in Childhood Vaccination
On 12th August, the MHRA reaffirmed the safety and effectiveness of childhood vaccines, highlighting the rigorous regulatory assessments undertaken before approval and the continued monitoring of vaccine safety once in use.
European Study Identifies Regulatory Research Priorities for AI in Medicines
On 13th August, a European-wide stakeholder study highlighted ten priority areas for regulatory science research on AI across the medicines lifecycle. The findings highlight AI accuracy and reliability, data governance, and ethics and bias prevention as key priorities for supporting the safe and effective use of AI in medicines development and regulatory decision-making.
MHRA Publishes UK Position Paper on Microbiome-Based Medicinal Products
On 18th August, the MHRA published a position paper outlining its approach to microbiome-based medicinal products (MBMPs). The paper aims to encourage the development and licensing of these emerging therapies in the UK, which have potential to address areas of significant unmet clinical need.
FDA Seeks Feedback on Regulation of Generative AI Medical Devices
On 18th August, the US Food and Drug Administration (FDA) published a discussion paper seeking stakeholder feedback on the regulation of generative AI-enabled medical devices. The paper explores key considerations including risk assessment, pre-market evaluation and post-market monitoring, with the aim of informing future regulatory approaches while supporting innovation and patient safety.
EMA Publishes Guide for Experts
On 18th August, the EMA published a new quick guide for EMA experts, covering key practical requirements including registration, declaration of interests and contractual arrangements. The guide provides experts with a clearer overview of the steps and requirements for working with the agency.
MHRA Issues August Safety Roundup
On 25th August, the MHRA published its August Safety Roundup, bringing together the latest safety advice and alerts for medicines and medical devices. The roundup includes updates on ventilator safety, medical device conformity, medicine recalls and device field safety notices, alongside recent pharmacovigilance and regulatory updates.
MHRA Highlights Health Innovation in Wales
On 27th August, the MHRA highlighted Wales’ connected health and life sciences ecosystem and its potential to support innovation from development through to adoption. The article also emphasises closer collaboration between regulators, innovators and the healthcare sector to help bring promising solutions to patients while supporting investment and growth.
MHRA Concludes Review of Avacopan Vifor
On 1st September, the MHRA announced it has concluded its review of Avacopan Vifor following concerns about the integrity and reliability of data from the pivotal clinical study supporting its approval. The review reassessed the medicine’s benefit-risk balance and considered the implications for its continued use in patients with severe autoimmune vasculitis.
MHRA Regulatory Reform Amendments Tabled In Government’s Health Bill
On 1st September, the Government tabled three amendments to the Health Bill aimed at modernising the UK regulatory framework for medicines and medical devices. The proposals would strengthen MHRA information-sharing powers, make legislation easier to update, and provide powers to support the future development of a medical device licensing regime. The measures are now subject to parliamentary scrutiny and do not introduce immediate regulatory changes.
Industry News
Innovation Passports Granted for Cancer and Dementia Treatments
On 4th August, the MHRA announced that two investigational medicines for liver cancer and dementia with Lewy bodies had been granted Innovation Passports through the Innovative Licensing and Access Pathway (ILAP). The designations provide developers with coordinated regulatory and market access support, helping to accelerate the development of promising treatments addressing significant unmet clinical needs.
FDA Approves First Medicine to Treat Full Range of Narcolepsy Type 1 Symptoms
On 5th August, the FDA approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 in adults. The medicine is the first approved treatment to address the condition by directly targeting the loss of orexin signalling, with clinical studies showing improvements across symptoms including excessive daytime sleepiness and cataplexy.
FDA Approves New Viral Immunotherapy for Advanced Melanoma
On 6th August, approved a new engineered viral immunotherapy for adults with treatment-resistant advanced melanoma, providing a new treatment option for patients whose melanoma has progressed despite previous therapies. The approval adds to the growing range of innovative immunotherapies being developed for advanced cancers.
UK Authorises Orforglipron for Weight Management and Type 2 Diabetes
On 10th August, the MHRA authorised orforglipron (Foundayo), making the UK the first country in Europe to approve this once-daily oral GLP-1 medicine for weight management and improving blood glucose control in adults with type 2 diabetes. The MHRA will continue to closely monitor its safety and effectiveness following authorisation.
Novo Nordisk And AWS Form AI Partnership To Speed Drug Discovery
On 10th August, Novo Nordisk and Amazon Web Services (AWS) announced a strategic partnership to accelerate drug discovery and modernise research and development through AI and cloud technologies. A new AI co-innovation hub in London will bring together scientists, engineers and AI specialists to help speed up the development of new medicines and reduce the time from drug discovery to clinical trials.
MHRA Advises Against Use of Rectal Catheters in Infants
On 18th August, the MHRA advised parents and carers not to use rectal catheters sold for personal use, including gas and colic relievers, in babies. The advice follows a review which found insufficient evidence of their safety and effectiveness, alongside concerns about potential injury and the risk of delaying diagnosis of underlying conditions.
AlzeCure Receives $10 Million Upfront Payment from Lilly
On 18th August, AlzeCure Pharma announced that it had received a $10 million upfront payment from Eli Lilly, completing the initial transaction under their collaboration and licensing agreement for the Alzstatin platform, including Alzheimer’s disease candidate ACD680. Lilly will take on global rights and responsibility for the continued development and commercialisation of ACD680, with the agreement potentially worth more than $1 billion, excluding royalties.
FDA Approves First Treatment for Warm Autoimmune Haemolytic Anaemia
On 24th August, the FDA approved IMAAVY® as the first treatment specifically approved for warm autoimmune haemolytic anaemia (wAIHA), a rare and potentially life-threatening condition. The approval provides a new targeted treatment option for patients with the disease, addressing a significant unmet medical need.
Carterra Supports Anthropic’s Autonomous AI Protein Design Study
On 24th August, Carterra highlighted the role of its high-throughput surface plasmon resonance (HT-SPR) platforms in Anthropic’s autonomous AI protein design study. Carterra’s technology was used by Twist Bioscience and Adaptyv Bio to analyse 1,320 AI-designed protein binders across 15 targets, helping generate binding affinity and kinetics data at scale and demonstrating the growing role of high-throughput experimental validation in AI-driven drug discovery.
First Wearable Device to Monitor Ketone and Blood Sugar Levels Authorised by FDA
On 25th August, the FDA authorised the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, the first wearable device in the world to continuously monitor both ketone and glucose levels. The device is intended for people aged two and older with diabetes and could help identify rising ketone levels earlier, potentially reducing the risk of serious complications such as diabetic ketoacidosis.
MHRA Identifies Increased Risks with Certain Hip Replacements
On 26th August, the MHRA identified an increased risk of wear and corrosion associated with certain cobalt-chrome modular neck hip replacements. NHS trusts and hospitals have been advised to identify affected patients and invite them for a clinical review to assess whether ongoing monitoring is required.
FDA Approves Mounjaro to Reduce Cardiovascular Risk
On 28th August, the FDA approved Mounjaro® (tirzepatide) to reduce the risk of major cardiovascular events, including cardiovascular death, non-fatal heart attack and non-fatal stroke, in adults with type 2 diabetes who are at high risk of these events. The approval expands Mounjaro’s established role in blood glucose control and weight management, providing an additional cardiovascular benefit for eligible patients.
FDA Approves Takeda’s MIMRYLO for Polycythemia Vera
On 28th August, the FDA approved MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a rare blood cancer. The first-in-class treatment is designed to regulate iron distribution and reduce excess red blood cell production, helping patients maintain haematocrit control and potentially reducing the need for frequent blood removal procedures.
EffRx Pharma and Androlabs Collaborate to Commercialise Testavan in Switzerland
On 31st August, EffRx Pharmaceuticals and Androlabs announced a strategic partnership to commercialise and distribute Testavan® in Switzerland. The testosterone replacement therapy is indicated for adult men with confirmed testosterone deficiency, expanding access to treatment options for men’s health in the Swiss market.
Lilly to Acquire Merida Biosciences
On 31st August, Eli Lilly announced an agreement to acquire Merida Biosciences for up to $2.875 billion, including upfront and milestone payments. The acquisition will strengthen Lilly’s immunology pipeline, with Merida’s lead programme MER511 targeting Graves’ disease and thyroid eye disease through a novel approach designed to selectively remove disease-causing antibodies.
Published Guidance
MHRA
- 17th August: Clinical trials: Phase 1, 14-Day Pilot Programme. Published guidance on the Phase 1 14-Day Pilot Programme, which aims to accelerate MHRA regulatory assessments for eligible low-risk Phase 1 clinical trial applications, targeting a 14-calendar-day first-wave assessment.
EMA
- 7th August: Product Management Services (PMS) – Implementation of International Organisation for Standardisation (ISO) standards for the identification of medicinal products (IDMP) in Europe. A fully revised version of the guidance, incorporating stakeholder feedback and recent developments in the implementation of ISO IDMP standards. Previous versions should no longer be used.
- 12th August: Product Management Service (PMS) FAQs. A new FAQ document addressing questions raised during recent PMS events, providing practical clarification on the service and its implementation.
- 19th August: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. Updated the pre-authorisation procedural advice for applicants using the centralised procedure, with changes provided in tracked format.
- 19th August: Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies – Q&A . Published Q&As clarifying the practical arrangements for notified bodies when consulting the EMA on companion diagnostics.
- 27th August: Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies – Q&A . Published updated recommended submission dates for veterinary medicinal product applications, supporting applicants in planning submissions to the EMA.
Updated Guidance
MHRA
- 5th August: Innovative Licensing and Access Pathway (ILAP). Updated ILAP guidance across several areas, including Target Development Profiles (TDPs), Joint Scientific Advice, application rounds, performance metrics and Innovation Passport information.
- 6th August: Clinical Investigations: Compiling a Submission. Updated guidance on submitting clinical investigation proposals for MHRA assessment, with requirements clarified and updated for applicants.
- 7th August: Good Laboratory Practice (GLP) For Safety Tests On Chemicals. Updated to reflect 2026/27 membership fees and removed information relating to GxP inspections and COVID-19.
- 8th August: Find Product Information About Medicines. Added the UK Additional Monitoring List for July 2026, identifying medicines subject to additional safety monitoring.
- 12th August: Clinical Investigations For Medical Devices. Updated the fee waiver process to require SME status at the eligibility-check stage and removed references to the fee waiver as a pilot.
- 13th August: Magnetic Resonance Imaging Equipment In Clinical Use: Safety Guidelines. Updated the guidance with a new cover image, UKAS updates and other minor corrections.
- 13th August: COVID-19 Test Approval: How To Apply. Introduced the CTDA Renewal Process and CTDA Renewal Application Portal for renewing Coronavirus (COVID-19) Test Device Approvals.
- 14th August: Medicines: Get Scientific Advice From The MHRA. Updated guidance to clarify submission requirements, supporting documentation, areas of expertise and meeting arrangements. From September 2026, final briefing documents and questions will be required when requesting Scientific Advice.
- 19th August: Clinical Trials For Medicines: Modifying a Clinical Trial Approval. Clarified that changes to investigators at trial locations in multicentre trials, other than the Chief Investigator, are considered Modifications of an Important Detail (MOIDs).
- 21st August: Guidance on Pharmacovigilance Procedures. Added further information on the European Union Reference Date (EURD) list, including clarification within section 5.2 of the guidance.
- 26th August: Medicines: Apply for a Parallel Import Licence. Updated the application guidance with further information on the submission process, including links to variation codes and required application cover sheets.
- 26th August: Opportunities for Patients and the Public to be Involved in the Work of the MHRA. Added a new section outlining the MHRA Payment Policy for public participation.
FDA – Final Guidances
- 3rd August: Applying Human Factors and Usability Engineering to Medical Devices. Final guidance setting out FDA recommendations for applying human factors and usability engineering to help ensure medical devices are safe and effective for their intended users, uses and environments.
- 5th August: CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern. Updated guidance on evaluating the microbiological effects of antimicrobial new animal drugs on bacteria of human health concern, supporting assessment of potential antimicrobial resistance risks.
25 Investigator Site Red Flags Leading to Regulatory Inspection Issues
Investigator sites play a critical role in ensuring clinical trials are conducted appropriately, with a focus on participant safety, data quality and regulatory compliance.
In our latest blog, we outline 25 investigator site red flags that can lead to issues, from protocol deviations and informed consent issues to data integrity, safety reporting, investigator oversight and essential document deficiencies.
To read more, click here.
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