Company News
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Regulatory Updates
EMA and African Regulatory Authorities Strengthen Collaboration on Ebola Response
On 3rd June, the European Medicines Agency (EMA) and African medicines regulatory authorities announced strengthened collaboration to support a coordinated response to Ebola outbreaks. The initiative aims to improve information sharing, regulatory alignment, and joint preparedness to enhance the assessment and availability of medical countermeasures during public health emergencies.
ICH Assembly Meeting Highlights Key Global Regulatory Outcomes
On 4th June, the International Council for Harmonisation (ICH) published key outcomes from its biannual Assembly meeting, outlining progress on global harmonisation of pharmaceutical regulatory standards. The update highlights agreement on new and revised guidelines aimed at improving the development, evaluation, and quality of medicines across participating regions.
MHRA Launches AI Sandbox to Accelerate Medicines Development and Improve Safety
On 9th June, the Medicines & Healthcare products Regulatory Agency (MHRA) launched an AI sandbox to support the safe development and evaluation of AI tools in medicines and healthcare. The controlled environment will allow developers, regulators, and healthcare partners to test AI systems, clarify regulatory expectations, and identify risks early, helping accelerate innovation while maintaining patient safety.
MHRA Publishes Landmark Report on Public Views of AI in Healthcare
On 11th June, the MHRA published a report on public attitudes to AI in healthcare, drawing on responses to a national call for evidence. The findings show broad support for AI’s potential benefits, alongside clear expectations for transparent regulation, robust safeguards, accountability, and public trust.
EMA 2025 Annual Report Highlights Strong Medicine Approval Activity
On 11th June, the EMA published its 2025 Annual Report, showing strong numbers of approvals for both human and veterinary medicines. The report highlights continued progress in supporting access to new treatments across Europe while maintaining rigorous standards for quality, safety, and effectiveness in regulatory decision-making.
EMA to Host CTIS Bitesize Talk on Annual Safety Reports and New Safety Module
On 12th June, the EMA announced a CTIS bitesize talk on Annual Safety Reports and the new safety module. The session will explain how ASRs are managed in CTIS, highlight changes intended to streamline sponsor submissions, and support more consistent EU oversight of clinical trial safety data. The event is scheduled for Thursday, 23 July 2026, from 12:00 to 13:30 BST.
MHRA Scientific Leader Recognised in 2026 King’s Birthday Honours
On 12th June, an MHRA scientific leader was recognised in the 2026 King’s Birthday Honours for their significant contributions to public health and regulatory science. The honour acknowledges their work in advancing medicines and medical device regulation, supporting innovation, and strengthening the safety and effectiveness of healthcare products in the UK.
MHRA and FDA Launch Unique Liaison Programme to Strengthen Collaboration
On 15th June, the MHRA announced a new liaison programme with the US Food & Drug Administration (FDA) designed to enhance close collaboration between the two regulators. The initiative aims to improve information sharing, support more aligned regulatory approaches, and strengthen cooperation on the development, assessment, and safety oversight of medicines and medical products.
MHRA Issues Drug Safety Update on ACE Inhibitor-Related Angioedema
On 16th June, the MHRA issued a Drug Safety Update highlighting the importance of distinguishing between bradykinin-mediated and histamine-mediated angioedema in patients taking ACE inhibitors, as the underlying cause requires different treatment approaches. The update emphasises prompt recognition and appropriate management to improve patient safety in cases of suspected ACE inhibitor-associated angioedema.
WHO Issues Comprehensive Guidelines on Filovirus Diseases
On 17th June, the WHO published comprehensive clinical management guidance for filovirus diseases, including Ebola and Marburg disease. The guidance brings together evidence-based recommendations on early supportive care, infection control, monitoring, and complication management to help standardise treatment in outbreak settings and improve survival outcomes.
MHRA Provides Update on Pathways Clinical Trial Progress
On 19th June, the MHRA provided an update on the Pathways clinical trial, outlining progress in the study and its continued focus on evaluating treatment approaches in a controlled clinical setting. The update highlights the trial’s role in generating evidence to support future regulatory and clinical decision-making.
EMA CVMP Meeting Highlights Key Veterinary Medicine Decisions
On 19th June, the EMA published highlights from the Committee for Veterinary Medicinal Products (CVMP) meeting, summarising key regulatory opinions and recommendations on veterinary medicines. The update reflects ongoing evaluation of product approvals, safety considerations, and regulatory guidance to support animal health across the EU.
FDA Issues Notifications on Data Integrity for Medical Devices
On 25th June, the FDA issued notifications reinforcing expectations for data integrity in medical device development, manufacturing, and regulatory submissions. The update highlights risks associated with incomplete or unreliable data and emphasises the need for robust quality systems, governance, and transparency.
EMA CHMP Meeting Highlights Key Human Medicines Decisions
On 26th June, the EMA published highlights from the Committee for Medicinal Products for Human Use (CHMP) meeting held from 22–25 June 2026, summarising key opinions and recommendations on human medicines. The update covers ongoing regulatory assessments, including marketing authorisation opinions and safety evaluations, supporting the continued review and approval of medicines across the EU.
FDA Selects Participants for PreCheck Pilot to Advance US Drug Manufacturing
On 29th June, the FDA announced the selection of seven participants for its PreCheck pilot programme, aimed at strengthening and modernising US drug manufacturing. The initiative is designed to support manufacturers in improving production quality and efficiency while enhancing regulatory engagement earlier in the development and manufacturing process.
MHRA Inspectorate Blog Explores Use of AI in GxP Inspection Responses
On 29th June, the MHRA Inspectorate published a blog on using AI to support GxP inspection responses. The article notes that AI can help structure and draft complex responses more efficiently, while stressing the need for human oversight, clear governance, accuracy, compliance, and transparency.
MHRA Issues June Safety Roundup
On 30th June, the MHRA published the latest Safety Roundup, summarising recent medicines recalls, medical device alerts, field safety notices, and other key safety communications issued to healthcare professionals. The update is designed to highlight emerging risks, regulatory actions, and important safety advice to support the safe use of medicines and medical devices across the UK.
EMA SME Highlights Newsletter Showcases Regulatory Support and Innovation Initiatives
The EMA’s latest SME Highlights newsletter outlines initiatives supporting small and medium-sized companies navigating the EU regulatory system. It includes updates on SME-focused events, developments in the PRIME scheme, new scientific advice pilots, and enhanced support for innovative medicines and medical devices. It also highlights progress in clinical trials regulation, greater use of real-world data, and ongoing regulatory science and digitalisation work, reflecting the EMA’s focus on innovation and stakeholder engagement.
NICE Recommends Annual Review for PMOS in Draft Guideline to Improve Diagnosis and Care
On 1st July, NICE published draft guidance recommending that people diagnosed with polyendocrine metabolic ovarian syndrome (PMOS) receive an annual review to monitor symptoms and long-term health risks. The guidance also aims to improve earlier diagnosis and more consistent assessment of associated risks, including fertility issues, cardiovascular disease, diabetes, and mental health conditions, to support better long-term care and management.
Published Guidance
MHRA
- 9th June: AI Airlock Sandbox Phase 2 Programme Report. Summarises findings from the second phase of the MHRA’s regulatory sandbox, which tested seven innovative AI medical technologies. The report highlights the challenge of regulating AI systems that evolve faster than traditional medical device frameworks and recommends stronger lifecycle management, real-world performance monitoring, and continued oversight as products adapt over time.
- 29th June: MHRA Innovation Accelerator. Introduces a new MHRA service combining the Innovation Office, Regulatory Advice Service for Regenerative Medicines, Regulatory Science, and Horizon Scanning. The Accelerator gives developers of medicines, medical devices, and other innovative healthcare products clearer access to scientific expertise, regulatory advice, and signposting to help navigate development pathways, including support for the Innovative Licensing and Access Pathway.
FDA – Draft Guidances
- 2nd June: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers. Answers common questions on how firms may communicate health care economic information about prescription drugs and medical devices to payors, formulary committees, and similar expert audiences involved in health care economic analysis.
- 15th June: Forms FDA 3542a and FDA 3542: Questions and Answers. Provides practical answers to frequently asked questions on preparing and submitting Forms FDA 3542a and FDA 3542, supporting applicants in meeting FDA patent information submission requirements.
- 24th June: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials. Sets out recommendations for using quantitative systems pharmacology approaches to support MABEL dose selection in first-in-human phase 1 trials, helping sponsors justify starting doses for products with potential biological activity at very low exposure levels.
- 24th June: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. Clarifies how the FDA assesses the strength of evidence supporting effectiveness for human drugs and biological products, including when one adequate and well-controlled clinical investigation, supported by confirmatory evidence, may satisfy the substantial evidence standard.
- 24th June: Master Protocols for Drug and Biological Product Development. Provides recommendations on the design, analysis, and regulatory submission of trials conducted under master protocols, supporting more efficient development programmes that evaluate multiple products, indications, or patient populations within a shared trial framework.
EMA
- 24th June: Eudralex Volume 4: Reference and Retention Samples (revised, applicable as of 24 September 2026). Updates requirements for taking and storing reference samples of starting materials, packaging materials, and finished medicinal products, as well as retention samples of finished products. The revision also clarifies expectations for investigational medicinal products and adds guidance on retention sampling for parallel imported and distributed medicines.
Industry News
FDA Expands Sunscreen Options for the First Time in 20 Years
On 9th June, the FDA announced the first expansion of approved sunscreen active ingredients in the US in around 20 years. The change is intended to increase consumer choice, support product innovation, and maintain standards for protection against UV-related skin damage.
Anocca Treats First Patients with Precision TCR-T Cell Therapy Targeting KRAS in Pancreatic Cancer
On 11th June, Anocca announced the first patient dosing in its VIDAR-1 clinical programme evaluating a precision TCR-T cell therapy for KRAS G12V-mutated pancreatic cancer. The early-stage study is assessing an engineered T-cell approach for a cancer type with limited treatment options and a poor prognosis.
MHRA Approves First GLP-1 Tablet for Weight Loss in the UK
On 11th June, the MHRA approved the UK’s first GLP-1 tablet for weight loss. The once-daily oral semaglutide treatment offers an alternative to injectable GLP-1 medicines for eligible adults with obesity or weight-related conditions, to be used alongside diet and exercise.
FDA Expands Use of TZIELD for Newly Diagnosed Pediatric Type 1 Diabetes Patients
On 15th June, the FDA approved a new indication for TZIELD (teplizumab), expanding its use to certain paediatric patients recently diagnosed with stage 3 type 1 diabetes. The decision broadens access to the therapy earlier in the disease course, aiming to help preserve insulin-producing beta cell function and slow disease progression in eligible patients.
FDA Approves First Single-Dose Generic Treatment for Influenza
On 17th June, the FDA approved the first single-dose generic treatment for influenza, expanding access to antiviral treatment options for flu. The approval is intended to increase affordability and availability of treatment while maintaining standards of safety, quality, and effectiveness in managing influenza infections.
Vedana Therapeutics Launches with $46 Million Series A Financing for Migraine Therapies
On 17th June, Vedana Therapeutics launched from stealth with $46 million in Series A financing to advance next-generation migraine prevention therapies. The company is developing antibody-based treatments targeting migraine pathways beyond CGRP, including PACAP, with the aim of improving options for patients who do not respond adequately to existing therapies.
Johnson & Johnson Reports Positive Results from MEMBRANE Trial Published in JAMA Neurology
On 19th June, Johnson & Johnson reported positive MEMBRANE trial results, published in JAMA Neurology, for middle meningeal artery embolization in chronic subdural haematoma. Adding the minimally invasive procedure to standard care significantly reduced recurrence or progression, supporting its potential role in reducing further surgical intervention.
AbbVie to Acquire Apogee Therapeutics to Strengthen Immunology Portfolio
On 22nd June, AbbVie announced an agreement to acquire Apogee Therapeutics for $10.9 billion. The deal strengthens AbbVie’s immunology pipeline by adding clinical-stage antibody programmes for inflammatory diseases, including atopic dermatitis and asthma.
NICE Recommends New Treatment Option for Recurrent or Metastatic Cervical Cancer
On 24th June, NICE recommended cemiplimab (Libtayo) as a treatment option for adults with recurrent or metastatic cervical cancer that has progressed after platinum-based chemotherapy and who have not previously received immunotherapy. The decision provides an additional immunotherapy option on the NHS, with evidence showing it can extend survival and delay disease progression compared with standard chemotherapy.
Enhertu Approved in EU for HER2-Positive Solid Tumours
On 29th June, AstraZeneca and Daiichi Sankyo announced EU approval of Enhertu for adults with previously treated HER2-positive metastatic solid tumours. The tumour-agnostic approval expands access to a targeted therapy for patients with limited treatment options across multiple cancer types.
FDA Approves New Treatment Using Donor Immune Cells to Prevent Blood Cancer Complications
On 30th June, the FDA approved a donor-derived immune cell therapy to help prevent serious complications in patients with blood cancers undergoing transplant procedures. The approval introduces a new option aimed at reducing post-transplant risks and improving outcomes.
Klick Health Acquires Oxford PharmaGenesis to Expand Scientific Communications Capabilities
On 30th June, Klick Health announced the acquisition of Oxford PharmaGenesis, expanding its scientific communications capabilities. The deal combines Oxford PharmaGenesis’ medical affairs expertise with Klick’s digital, creative, and analytics offering for life sciences clients.
WHO Expands Global Health Inequality Monitoring Network
On 30th June, the WHO expanded its Health Inequality Monitoring Network, doubling global membership. The initiative aims to improve collaboration, data availability, and use of comparable evidence to support policies that reduce health disparities.
Updated Guidance
MHRA
- 8th June: Clinical trials for medicines: modifying a clinical trial approval. Updated the decision tree for determining the correct category for a modification to reflect that sponsors must begin by determining whether the modification is substantial.
- 9th June: AI Airlock Simulation Workshops. Added three additional simulation workshop reports from the second phase of the AI Airlock programme, providing further insight into regulatory testing of AI medical technologies.
- 9th June: Opportunities for patients and the public to be involved in the work of the MHRA. Expanded information on the MHRA’s commitment to patient and public involvement and engagement, including the role of the Public and Patient Involvement and Engagement Team. The update also revised information on the Public and Patient Community and removed material relating to public board sessions.
- 11th June: Medical devices: ask for a regulatory advice meeting from the MHRA. Added further detail on how to request a regulatory advice meeting, updated information on fee timings, and provided a revised point of contact for enquiries.
- 11th June: Regulation of medical devices in Northern Ireland. Added an updated point of contact email for queries relating to the regulation of medical devices in Northern Ireland.
- 17th June: Project Orbis. Added variation details for KEYTRUDA, keeping the Project Orbis guidance current with recent regulatory updates.
- 24th June: COVID-19 test validation approved products. Updated the spreadsheet of products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations, ensuring the list reflects the latest validated COVID-19 test products.
- 25th June: MHRA Innovation Office: guidance and support. Refreshed the page with additional information and usability improvements, making it easier for innovators to access relevant MHRA guidance and support.
- 26th June: Register medical devices to place on the market. Updated the fees section to confirm that the annual fee payment deadline has been extended to 31 July 2026.
- 29th June: Borderline products: medical devices and other products. The guidance has been updated to state that alcohol-only pre-injection swabs and wipes are considered medical devices, with the previous reference to antimicrobial-containing products (such as chlorhexidine, cetrimide, or iodine) removed.
FDA – Final Guidances
- 2nd June: M15 General Principles for Model-Informed Drug Development. Sets out harmonised principles for planning, evaluating, documenting, and submitting evidence generated through model-informed drug development. The guidance also outlines terminology, assessment expectations, and recommendations for regulatory interactions.
- 4th June: Certain Post-Approval Requirements and Resources for ANDAs. Summarises key statutory and regulatory post-approval requirements for holders of abbreviated new drug applications and signposts relevant FDA guidance and resources to support ongoing compliance.
- 5th June: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements. Describes FDA’s intent to exempt certain unclassified medical devices from premarket notification requirements where the Agency considers that the devices meet the applicable standards for exemption.
- 29th June: Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus. Updates FDA recommendations for blood establishments on donor eligibility, deferral, and blood product management during Ebola outbreaks. The guidance classifies Ebola disease as a transfusion-transmitted infection and replaces the earlier 2017 recommendations.
EMA
- 15th June: IRIS guide for applicants. Provides practical instructions for industry and individual applicants using EMA’s Integrated Regulatory Information System (IRIS) to create, submit, and manage scientific and regulatory applications. The guide covers account access, organisation registration, required identifiers, and submissions for procedures including scientific advice, orphan designation, inspections, and other regulatory interactions.
25 Lessons Learned When Conducting CAPA in Pharmaceutical Environments (GMP, GCP, GVP, GLP)
As part of our 25 Years of Tower Mains series, we’re sharing insights from conducting Corrective and Preventive Action (CAPA) in pharmaceutical environments.
CAPA is a cornerstone of pharmaceutical quality systems, providing a structured framework to investigate deviations, identify root causes, implement corrective actions, and prevent recurrence.
Drawing on experience across GMP, GCP, GVP, and GLP environments, these 25 lessons highlight common CAPA challenges and practical approaches for strengthening robust, risk-based, and inspection-ready quality systems.
To read more, click here.
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