The European regulatory landscape continues to evolve rapidly, with new initiatives aimed at balancing innovation, safety, and patient access. This week’s developments span artificial intelligence in medicine, updated clinical trial guidance, new requirements for diagnostics, and broader efforts to simplify Europe’s complex regulatory framework.
EMA and HMA Launch AI Research Consultation
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have begun a consultation to determine research priorities for artificial intelligence (AI) in the development and evaluation of medicines.
Through the joint HMA-EMA Network Data Steering Group (NDSG), regulators, industry stakeholders, and other experts are invited to provide feedback on seven AI research domains, including:
- Regulation and Oversight – accountability frameworks, best practices, and legal applicability.
- Data Governance, Confidentiality, and Consent – ethical and lawful handling of patient data, with strong privacy protections.
Respondents are asked to prioritize which areas require the most immediate focus and highlight any gaps in the survey’s scope. The consultation will remain open until October 17, 2025, after which findings will be shared with the research community.
EMA Drafts Guidelines for Key Diseases
Alongside AI initiatives, EMA has released two updated draft guidelines and one draft concept paper:
- Chronic Hepatitis B – revisions reflect efforts to achieve functional cures and propose new primary endpoints.
- Psoriatic Arthritis – guidance updates trial design, patient populations, and endpoints to align with current therapies.
- Idiopathic Pulmonary Fibrosis (IPF) – a new draft concept paper outlines considerations such as comparator choice, trial design, and outcome measures.
Feedback is open until March 31, 2026 for hepatitis B and psoriatic arthritis, while the IPF paper will accept comments through the end of 2025.
MHRA Clarifies Diagnostics in UK Trials
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on using in vitro diagnostic (IVD) devices in clinical trials. The rules cover UKCA- or CE-marked devices, exemptions for health institution–manufactured IVDs, and requirements for analytical performance data when no prior validation exists.
Applicants must disclose IVD use in cover letters and confirm compliance with device regulations, reinforcing the UK’s focus on patient safety and trial transparency.
European Council Pushes for Simplification
The European Council has urged immediate action to simplify what it describes as “a complex regulatory framework” that hinders innovation and market access. The Council emphasized:
- Reducing Administrative Burdens – calling for measures under the upcoming European Innovation Act.
- Better Use of Health Data – improving coordination of existing initiatives for research and innovation.
This reflects growing recognition that regulatory complexity can undermine Europe’s competitiveness in the global life sciences sector.
EDQM Publishes Prescription Guidelines
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has issued guidance on when medicinal products should require a prescription. The evaluation process considers the active substance, safety profile, and potential risks of misuse. This harmonized approach aims to support consistent decision-making across member states.
Other Notable Updates
- Swissmedic has formalized clarification meetings after a successful pilot program, giving sponsors an additional opportunity to address regulator concerns.
- European Commission has launched antitrust inspections of Sanofi amid concerns of exclusionary practices.
- UK VPAG Scheme – pharma companies have until October 31, 2025, to decide whether to remain in the voluntary pricing and access agreement.
EMMA International’s Perspective
At EMMA International, we closely monitor global regulatory shifts to ensure our clients remain prepared and compliant. Europe’s evolving approach—spanning AI in medicine, disease-specific trial guidance, and streamlined frameworks—signals both opportunity and responsibility for sponsors.
From navigating complex EU classifications to aligning with EMA and MHRA trial expectations, our experts provide tailored strategies that help life science companies anticipate challenges and accelerate development. As AI and other emerging technologies reshape regulatory science, EMMA International is committed to guiding organizations toward safe, effective, and compliant innovation.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
References
Taylor, N. P. (2025, October 2). Euro Roundup: Joint HMA-EMA group starts consultation into priorities for AI in research and regulation. Regulatory Affairs Professionals Society.
European Medicines Agency. (2025, September). Draft guidelines and concept paper for stakeholder consultation. EMA.onal.com to learn more.
