6 November 2025
From the newsfeeds of the European Medicines Agency’s (EMA), the European Commission (EC) and the Head of Medicine Agencies (HMA), Arex Advisor has rounded up a selection of highlights from October 2025.
EMA
Submission deadlines for Type I variations at the end of 2025
2 October 2025
EMA has issued a reminder for marketing authorisation holders to submit individual Type IA, Type IAIN variations, and super-groupings by 21 November 2025. This ensures the Agency can validate submissions before its year-end closure from 23 December 2025 to 5 January 2026, in line with the 30-day deadline set by Article 14 of Regulation (EC) No 1234/2008. Annual updates should follow the timelines outlined in the revised Variation Regulation and related guidance. Read more
EMA
Minutes from the Enpr-EMA Coordinating Group and networks meeting
2 October 2025
A joint ACT EU/Enpr-EMA workshop on paediatric clinical trials in early 2026 was proposed. The idea of forming a programme committee to shape the agenda was welcomed. Topics suggested included issues faced by non-commercial sponsors, innovative trial formats like platform trials, and the use of extrapolation. Read more
EMA
EMA’s Management Board shared key points from its October 2025 meeting.
3 October 2025
Board notes mid-year report and endorses first network data strategy. EMA presented results and achievements of its operations for the first half of 2025. Between January and June, applications for new medicines (orphan and non-orphan) remain at the same high level as last year (29 vs 30 applications in Q1-Q2 2024). In veterinary medicines, the Board noted the same high level of applications as in 2024 (12 vs 11 applications in Q1-Q2 2024) and anticipates an increase above the initial forecast for the whole of 2025. Read more
EMA
Regulatory data: Big data and other sources
3 October 2025
EMA relies on various data sources to support its regulatory decisions, including big data such as real-world evidence from electronic health records and patient registries. Advanced analytics, including AI-based methods, are used to ensure transparent and robust assessments of medicine safety, efficacy, and quality. Read more
EMA
Minutes from the PCWP meeting
3 October 2025
Summary of the Patients and Consumers Working Party (PCWP) meeting. Read more
EMA
EU enlargement
7 October 2025
EMA participates in initiatives to strengthen ties with EU enlargement countries, helping to build the groundwork for future collaboration within its regulatory networks. Read more
EMA
Revised Q&A on impact of EU-USA MRA
10 October 2025
How the EU–US Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations. Read more
EMA
ICH M14 guideline adopted by CHMP
10 October 2025
ICH M14 Guideline outlines key principles for planning, designing, analysing and reporting non-interventional studies using Real-World Data to assess medicine safety. Read more
EMA
Highlights from the CHMP meeting 13–16 Oct 2025
17 October 2025
Two medicines received positive opinions for approval, while eight others were recommended for expanded therapeutic use. Read more
EMA
EMA content collaboration for safe use of GLP-1 medicines
21 October 2025
EMA has launched its first social media campaign, #HealthNotHype, in collaboration with content creators. The campaign aims to broaden the reach of public health messages and promote the safe use of GLP-1 receptor agonists. Read more
EMA
Scientific guideline on the use of non-human primates in safety testing
23 October 2025
This reflection paper outlines scientific and regulatory aspects of using non-human primates in safety testing of human medicines. It points to existing flexibility in current guidelines for applying 3Rs principles and explores emerging alternatives. Read more
EMA
Guideline on the quality requirements for phage therapy medicinal products.
24 October 2025
This guideline sets out regulatory expectations for the quality documentation of 44 bacteriophage active substances and finished products intended for human use. It covers manufacturing processes, material controls, characterisation, specifications, analytical methods, reference standards and stability. It also provides guidance on pharmaceutical development. Read more
EMA
Guideline on the quality requirements for phage therapy medicinal products.
24 October 2025
This guideline sets out regulatory expectations for the quality documentation of 44 bacteriophage active substances and finished products intended for human use. It covers manufacturing processes, material controls, characterisation, specifications, analytical methods, reference standards and stability. It also provides guidance on pharmaceutical development. Read more
EMA
EMA launches awareness campaign on medicine shortages
4 November 2025
The European Medicines Agency (EMA), together with healthcare professional and consumer organisations, has launched the #ItTakesATeam campaign to raise awareness of medicine shortages across the EU. The initiative emphasises the shared responsibility of healthcare stakeholders in preventing and managing shortages, and in supporting patients affected by supply disruptions. Read more
EC
European Commission seeks feedback on future health crisis plan
1 October 2025
The European Commission has launched a Call for Evidence to gather input on the EU’s future plan for preventing, preparing for, and responding to health crises. The consultation invites contributions from citizens, healthcare professionals, public institutions, patient organisations, NGOs, academia, and other stakeholders wishing to share their perspectives. Read more
EC
EU adopts rules for joint clinical assessments of medical devices
17 October 2025
The European Commission has adopted new rules governing joint clinical assessments for medical devices and in vitro diagnostic medical devices under the Health Technology Assessment (HTA) framework. The measures aim to harmonise evaluation processes across the EU, improving consistency and reducing duplication for manufacturers and national authorities. Read more
EC
EU HTA Regulation webinar recording now available
22 October 2025
A recording of the European Commission’s webinar held on 17 October 2025 is now available, providing guidance for health technology developers of medicinal products on implementing the EU Health Technology Assessment (HTA) Regulation. The session covered practical aspects of joint clinical assessments and upcoming procedural steps for developers. Read more
EC
European Commission updates EudraLex Volume 10 clinical trial guidance
30 October 2025
The European Commission has published new and updated documents in EudraLex Volume 10, including recommendations on selecting a reporting Member State, guidance on decentralised elements in clinical trials, and advice on frequent issues related to Parts I and II assessments. An updated paper on auxiliary medicinal products in clinical trials has also been released to support consistent regulatory practice across the EU. Read more
HMA
New guidance published for D70 and D120 Assessment Report Overview templates
23 October 2025
The European Medicines Agency has released explanatory notes for the “D70 AR Overview Template,” providing detailed instructions for assessors on completing and adapting the template. The document also outlines the modifications required when converting the D70 Assessment Report Overview into the D120 version and includes standard statements to support consistent reporting, particularly for generic applications. Read more
HMA
Updated CMDh Q&A clarifies post-Brexit procedures for medicinal products
23 October 2025
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has consolidated its post-Brexit guidance into a single Questions & Answers document. The update, agreed in October 2025, retains only content relevant after the UK’s withdrawal and the Trade and Cooperation Agreement, providing procedural and practical clarification for medicinal products approved via the MRP and DCP routes. Read more
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