Regulatory Updates
EMA Launches Initiatives to Strengthen Medicines Development for Women’s Health
On 2nd July, the EMA announced new initiatives to address gaps and challenges in women’s health and support the development of medicines that better reflect women’s needs. The activities will focus on improving evidence generation, representation in clinical trials, assessment and labelling of medicines, use of medicines during pregnancy and breastfeeding, and the use of real-world evidence to inform regulatory decisions.
DG SANTE and EMA Strengthen Collaboration with New Zealand Ministry of Health on Medicinal Products
On 7th July, the European Commission’s DG SANTE and the EMA announced a new Working Arrangement with New Zealand’s Ministry of Health, including Medsafe, to strengthen cooperation and information exchange on medicinal products. The arrangement aims to support regulatory alignment, sharing of best practices, and collaboration on the quality, safety, and efficacy of medicines.
ICH E6(R3) Good Clinical Practice Guideline Completed with Adoption of Annex 2
On 10th July, the International Council for Harmonisation (ICH) announced the adoption and publication of Annex 2 of ICH E6(R3): Good Clinical Practice, completing the revision of this key guideline. The updated guideline provides additional considerations for modern clinical trial approaches, including decentralised trials, pragmatic trials, and the use of real-world data, and has been consolidated with the Principles and Annex 1 into a single document.
FDA Proposes Rule to Modernise Drug Manufacturing Registration
On 10th July, the FDA proposed a new rule to modernise drug manufacturing registration requirements by creating a streamlined pathway for distributed manufacturing facilities and improving oversight of foreign drug manufacturing establishments. The proposal aims to strengthen supply chain transparency, support innovative manufacturing models, and improve visibility into the sources of medicines and active pharmaceutical ingredients entering the US market.
MHRA Launches AI Medical Device Regulatory Sandbox in London
On 10th July, the MHRA, in partnership with NHS England London and the London Health Innovation Networks, launched the London Region I AI Regulatory Sandbox to support real-world testing of AI-enabled medical devices. The programme aims to generate evidence on safety and effectiveness and support the responsible adoption of innovative technologies in NHS settings.
EMA Executive Director Updates EU Parliament on Regulatory Priorities and Achievements
On 15th July, EMA Executive Director Emer Cooke addressed the European Parliament’s Committee on Public Health, highlighting key achievements from 2025 and ongoing priorities, including preparations for the new EU pharmaceutical framework, women’s health initiatives, medicines supply resilience, and strengthening clinical trial and regulatory systems.
EMA and EISMEA Strengthen Cooperation to Accelerate Health Innovation
On 15th July, the EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) announced strengthened cooperation to support health innovation in the EU. The collaboration aims to help innovators better understand regulatory requirements, accelerate the development of medicines and health technologies, and support SMEs, start-ups, research organisations, and universities in bringing innovative solutions to patients.
EMA Highlights Clinical Trial Improvements Through ACT EU and CTIS Updates
The June 2026 edition of Clinical Trials Highlights showcases two years of ACT EU Multi-stakeholder Platform collaboration, focusing on improving clinical trial authorisation, reducing administrative burden and strengthening patient involvement. The newsletter covers CTIS updates, including new notifications, safety module enhancements, sponsor reminders, a recruitment and informed consent template, training opportunities and AI developments.
MHRA Strengthens Warnings for Botulinum Toxin Products
On 15th July, the MHRA announced updated safety warnings for all botulinum toxin type A products following rare reports of botulism linked to their use. Product information has been updated to highlight the risk of toxin spread beyond the injection site and the importance of seeking urgent medical attention if symptoms occur.
MHRA Reports Strong Performance in 2025–26 Annual Report
On 16th July, the MHRA published its 2025–26 Annual Report and Accounts, highlighting strong delivery across medicines regulation, public health protection, and innovation. Key achievements included authorising new medicines, disrupting illegal medicines supply chains, advancing AI regulation, and strengthening the UK’s global regulatory position.
FDA Selects First Participant for Digital Health Device Pilot
On 22nd July, the FDA announced the first participant selected for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. Dexcom was chosen to evaluate its Dexcom Glucose Health Program, with the pilot aiming to generate real-world evidence on how digital health technologies can improve outcomes for people managing chronic conditions while supporting safe patient access to innovative care solutions.
MHRA Clarifies Regulation of Ambient Voice Technologies in the NHS
On 29th July, the MHRA published guidance clarifying the regulatory status of ambient voice technology (AVT) products used in the UK’s health and care settings. The guidance explains which AVT functions are regulated as medical devices and provides clarity for developers, suppliers, and NHS organisations to support safe adoption of AI-enabled tools.
EMA Announces New Leadership Appointments
On 30th July, the EMA announced changes to its leadership team, with Melanie Carr appointed to Deputy Executive Director duties from 1 August 2026 and Franck Fourès appointed as Head of the Veterinary Medicines Division from 1 September 2026. The appointments follow the retirement of Ivo Claassen, who has served as Deputy Executive Director since 2021.
ICH Publishes Updated Support Package for Electronic Common Technical Document (eCTD)
On 30th July, the ICH announced the publication of an updated support package for ICH M8: Electronic Common Technical Document (eCTD). The update provides revised implementation resources to support the use of eCTD v4.0 and facilitate consistent regulatory submissions across ICH regions.
HRA Highlights Faster Research Approvals and New Guidance
On 30th July, the Health Research Authority (HRA) shared updates on efforts to improve the speed, quality and accessibility of health and social care research. The bulletin highlighted a fast-track ethics review supporting an Ebola vaccine trial, new guidance for NHS and health and social care staff studies, updated information on children’s informed consent, and initiatives to strengthen research through feedback and patient engagement.
Industry News
AlzeCure Pharma Signs $2.2 Billion Licensing Deal for Alzheimer’s Drug Candidate
On 1st July, AlzeCure Pharma entered an out-licensing and collaboration agreement with QuantumCell for its NeuroRestore platform, including clinical-stage Alzheimer’s candidate ACD856. The deal includes a $12 million upfront payment, milestones and royalties, with potential value exceeding $2.2 billion excluding royalties. ACD856 is a small-molecule Trk-PAM candidate targeting Alzheimer’s and other CNS conditions.
Novartis Gains EU Approval for Itvisma Gene Therapy for SMA
On 2nd July, Novartis received European Commission approval for Itvisma® (onasemnogene abeparvovec), the first EU-approved gene replacement therapy for children aged two and older, teens and adults with 5q spinal muscular atrophy (SMA). The one-time treatment replaces the faulty SMN1 gene and offers a new option alongside existing therapies.
Incyte Acquires Vega Therapeutics to Expand Haematology Pipeline
On 6th July, Incyte announced the completion of its acquisition of Vega Therapeutics, adding VGA039, an investigational monoclonal antibody in Phase 3 development for von Willebrand disease (VWD), to its haematology portfolio. The acquisition strengthens Incyte’s late-stage pipeline and expands its focus into bleeding disorders.
EMA Begins Phased Review of Medicine for Metastatic Pancreatic Cancer
On 7th July, the EMA announced the start of a phased review of daraxonrasib, a medicine for metastatic pancreatic cancer with potential to address a high unmet medical need. The approach aims to accelerate assessment by reviewing quality, nonclinical, and clinical data as they become available, ahead of a full marketing authorisation application.
MHRA Secures Convictions Following Illegal Online Medicines Supply Investigation
On 8th July, the MHRA announced that four individuals had been sentenced following a major investigation into an organised criminal network involved in the illegal online supply of controlled drugs, prescription-only medicines, and unauthorised medicinal products. The investigation, Operation Lamborghini, uncovered the distribution of nearly two million doses of medicines supplied without appropriate safeguards.
MHRA Approves Use of UK Donor Plasma for Additional Medicines
On 9th July, the MHRA announced approval for the use of UK-donor plasma in the manufacture of five additional plasma-derived medicinal products following a safety review. The decision supports more resilient supplies of essential medicines, including treatments for bleeding disorders, immune conditions, and other serious health conditions, while reducing reliance on imported plasma.
NHS England Recommends Twice-Daily Cystinosis Treatment Option
On 16th July, NHS England recommended routine commissioning of delayed-release mercaptamine bitartrate for eligible patients aged one year and above with nephropathic cystinosis. The treatment provides a twice-daily dosing option compared with the existing four-times-daily formulation, helping reduce treatment burden and potentially improve adherence and quality of life.
OrbusNeich Begins Japan Trial for Drug-Coated Balloon Technology
On 22nd July, OrbusNeich enrolled the first patient in its pivotal Japanese clinical trial evaluating its proprietary paclitaxel drug-coated balloon for coronary artery disease. The multi-centre study will assess safety and efficacy in treating coronary lesions, supporting future regulatory submission to Japan’s PMDA.
Roche’s Susvimo Recommended for EU Approval
On 24th July, Roche announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Susvimo (ranibizumab injection) for the treatment of neovascular age-related macular degeneration (nAMD). The continuous delivery treatment, administered through the Contivue refillable implant, is intended to reduce treatment frequency while maintaining vision outcomes.
EMA Recommends First Oral IL-23 Receptor Medicine for Plaque Psoriasis
On 24th July, EMA’s CHMP recommended approval of Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis in adults and adolescents. Icotyde would be the first authorised oral medicine targeting the interleukin-23 pathway, offering a new treatment option for patients with this chronic inflammatory skin condition.
Novogene Europe Expands Single-Cell Sequencing Services in Cambridge
On 27th July, Novogene Europe expanded its single-cell RNA sequencing capabilities at its Cambridge Omics Centre, providing UK researchers with access to 10x Genomics-based workflows, sequencing infrastructure and bioinformatics support. The expansion strengthens the centre’s role as a hub for advanced multiomics services across areas including oncology, immunology, neuroscience and drug discovery.
FDA Licenses First Freeze-Dried Plasma Product in the US
On 29th July, the FDA licensed Ezplaz Freeze Dried Plasma, the first freeze-dried plasma product approved for use in the United States. The room-temperature-stable plasma product can be rapidly reconstituted for emergency transfusions, providing a new option for treating life-threatening bleeding in settings such as remote locations, disaster zones, and combat environments where conventional frozen plasma may not be available.
Cytokinetics Receives UK Approval for Oral Treatment for Obstructive Hypertrophic Cardiomyopathy
On 30th July, Cytokinetics announced that the MHRA has granted marketing authorisation for MYQORZO® (aficamten), an oral pill, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy in eligible adults in the UK. The approval, alongside positive NICE guidance for use in England and Wales, provides a new treatment option designed to improve symptoms and exercise capacity for patients with this inherited heart condition.
MHRA Grants Innovation Passports to Cancer and Dementia Medicines
On 4th August, the MHRA announced that two investigational medicines in development for liver cancer and dementia with Lewy bodies have received Innovation Passport designations through the UK’s Innovative Licensing and Access Pathway (ILAP). The designations recognise promising treatments addressing significant unmet medical needs and provide developers with coordinated regulatory and market access support to help accelerate their development.
Takeda Receives FDA Approval for First Medicine Targeting Narcolepsy Type 1 Cause
On 5th August, Takeda announced that the FDA approved ORZEYFUL™ (oveporexton), a medicine in the US designed to target the underlying cause of narcolepsy type 1 rather than individual symptoms. The oral orexin receptor 2 agonist provides a new treatment approach for adults with the condition, with clinical trials showing improvements across excessive daytime sleepiness, cataplexy and quality of life measures.
Published Guidance
Medicines & Healthcare products Regulatory Agency (MHRA)
- 29th July: Ambient voice technology-enabled products. New guidance on the qualification and classification of ambient voice technology-enabled products (AVT products) intended to be placed on the market or put into service in Great Britain.
- 30th July: London Region I MHRA Regulatory Sandbox: call for expressions of interest. Expressions of interest are invited from AI-enabled medical device manufacturers and NHS provider organisations to participate in the London Region I MHRA Regulatory Sandbox. The programme, announced in June 2026, will bring together industry, NHS organisations and regulatory experts to support the safe and responsible deployment of innovative technologies in real-world healthcare settings in London.
US Food & Drug Administration (FDA) – Draft Guidances
- 31st July: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts. Expands on and clarifies FDA recommendations and expectations for developing container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products.
- 31st July: Assessing the Irritation and Sensitisation Potential of Transdermal and Topical Delivery Systems for ANDAs. Clarifies FDA recommendations and expectations for assessing the irritation and sensitisation potential of transdermal and topical delivery systems in support of abbreviated new drug application (ANDA) submissions.
European Commission
- 10th July: Safety features for medicinal products for human use. Questions and Answers (Q&A) guidance document providing practical clarification on the EU safety features requirements for human medicines. It supports stakeholders involved in the medicines supply chain, including manufacturers, marketing authorisation holders, wholesalers, pharmacies, and national competent authorities.
Updated Guidance
MHRA
- 7th July: Clinical trials for medicines: roles and responsibilities. The survey introduction was removed because it is out of date.
- 9th July: Access, new active substance and biosimilar work sharing initiatives. Amended to add type-II variation to Lynkuet (elinzanetant).
- 10th July: Find product information about medicines. UK Additional monitoring list for June 2026 was added.
- 14th July: In vitro diagnostic point-of-care test devices. Removed outdated references across multiple sections. Updated the section on training and UKAS accreditation for POCT. Revised the incident reporting section to clarify the scope of medical device incident reporting and the appropriate reporting pathways across different parts of the UK.
- 14th July: International Recognition Procedure. Added new sections on the scope of the International Recognition Procedure (Section 2), validation (Section 5), and MHRA contact details (Section 11). Updated guidance on IRP timetable extensions (Section 4.3), the application process and pre-submission support (Section 7), ATMP eligibility (Section 8.4), and Reference Medicinal and Comparator Products for bioequivalence and therapeutic equivalence testing (Section 8.8).
- 15th July: Clinical trials for medicines: modifying a clinical trial approval. Clarified the submission route for responses to requests for information (RFIs) relating to modifications.
- 15th July: Clinical trials for medicines: Clinical Trials Regulations transitional arrangements. Minor wording changes to reflect that new regulations are now in force.
- 20th July: Custom-made medical devices in Great Britain. Updated to clarify registration requirements for custom-made devices.
- 20th July: Medical devices: legal requirements for specific medical products. Updated to clarify registration requirements.
- 20th July: Register medical devices to place on the market. Clarified guidance relating to devices put into service only.
- 23rd July: Approving clinical investigations. Substantial content remains unchanged, with clarifications added, wording simplified, and grammatical errors corrected.
- 23rd July: Clinical investigations in Great Britain. Reordered information to improve logical flow and consistency. Added guidance on when to conduct a clinical investigation and removed duplicate content.
- 23rd July: Clinical investigations for medical devices. Added minor clarifications and updated the Serious adverse event (SAE) reporting section to reflect studies conducted in both Great Britain and Northern Ireland.
- 23rd July: Medical devices that need a clinical investigation. Broken links fixed and minor clarifications added.
- 27th July: Safety Public Assessment Reports. Added the Public Assessment Report on bladder anticholinergics: review of the risk of dementia.
- 27th July: AI Airlock Sandbox Phase 2 Programme Report. Updated the AI Airlock Phase 2 programme report to amend the MHRA engagement route outlined in Recommendation 20.
- 29th July: Digital mental health technology: qualification and classification. Updated guidance to improve clarity and reflect stakeholder engagement, revised DMHT qualification criteria, updated software classification guidance, and amendments to functions 10 and 11. Added title numbering and clarified guidance on accessories, multi-modular and interconnected DMHTs, including updates to EU MDR classification rules.
- 30th July: Magnetic resonance imaging equipment in clinical use: safety guidelines. Updated the MHRA Safety Guidelines for Magnetic Resonance (MR) Imaging Equipment in Clinical Use to the fifth edition, incorporating input from professional organisations and international MR safety experts.
- 31st July: Clinical trials for medicines: MHRA phase I accreditation scheme. The List of Phase 1 accreditations was updated.
- 5th August: Innovative Licensing and Access Pathway (ILAP). Updated multiple ILAP pages, including TDP and Joint Scientific Advice sections, application guidance with additional round dates, and Performance Metrics, quarterly updates, and Innovation Passport lists.
- 6th August: Clinical investigations: compiling a submission. Updated the ‘Submitting a clinical investigation proposal for MHRA assessment’ document to clarify and update requirements.
FDA – Final Guidances
- 1st July: Submitting Next-Generation Sequencing Data to the Division of Antiviral Products. Technical specifications document providing FDA guidance on the submission of next-generation sequencing (NGS) protocols, data, and analyses to support antiviral drug resistance assessments.
- 14th July: Psychedelic Drugs: Considerations for Clinical Investigations. General considerations and recommendations for sponsors conducting clinical investigations of psychedelic drugs, including guidance on developing these therapies for medical conditions.
- 14th July: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence. Clarity for applicants on bioequivalence requirements for topical dermatologic corticosteroids, including recommendations for pilot dose duration, vasoconstrictor response studies, and pivotal bioequivalence studies using pharmacodynamic approaches.
- 23rd July: Hemodialysis Blood Tubing Sets — Premarket Notification (510(k)) Submissions. FDA recommendations for 510(k) submissions for hemodialysis blood tubing sets to promote consistency and support efficient review.
- 27th July: Cancer Clinical Trial Eligibility Criteria: Performance Status. Recommendations for expanding eligibility criteria in cancer clinical trials, including broader inclusion of patients with varying performance status, to improve trial representativeness and applicability of clinical data.
- 27th July: Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications. Provides recommendations for expanding eligibility criteria in cancer clinical trials by reassessing washout periods and concomitant medication restrictions to improve trial representativeness and applicability of clinical data.
- 27th July: Cancer Clinical Trial Eligibility Criteria: Laboratory Values. Recommendations on selecting appropriate laboratory values as eligibility criteria for cancer clinical trials to avoid unjustified exclusions and support more representative trial populations.
- 31st July: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs. Guidance for assessing adhesion performance of transdermal and topical delivery systems in studies supporting abbreviated new drug application (ANDA) submissions, including studies evaluating adhesion alone or alongside bioequivalence endpoints.
- 3rd August: Applying Human Factors and Usability Engineering to Medical Devices. Provides FDA recommendations on applying human factors and usability engineering processes to improve medical device design, minimise use errors, and reduce risks associated with device use.
- 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. Guidance on evaluating the microbiological effects of antimicrobial new animal drugs on bacteria of human health concern and outlines a risk assessment approach for assessing microbial food safety risks.
Why the Best Quality Systems Are Not the Most Complex
Does a more complex quality system produce better quality outcomes? Increasingly, the answer is no.
Somewhere along the way, complexity became confused with quality. More procedures, approvals, and controls can create the appearance of stronger governance, but a system that is difficult to use can become disconnected from the reality of how work is performed.
In our latest article, we explore the “gold-plated quality system” trap and why the most effective quality systems are not those with the most documentation, but those that are:
- Proportionate to risk
- Practical for the people who use them
- Aligned with operational reality
- Designed to evolve as organisations grow
Quality systems should enable better decisions and support effective operations, not create unnecessary complexity.
The goal is not to build the most sophisticated system.
It is to build the right system for the organisation, one that people understand, use, and trust.
To read more, click here.
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