The European Commission has published new and updated guidance documents in Volume 10 of “The Rules Governing Medicinal Products in the European Union”, which applies to clinical trials under the Clinical Trials Regulation (EU) No 536/2014.
These updates, published on 30 October 2025, provide essential information and are relevant for sponsors and stakeholders involved in clinical trials within the EU.
The updated guidance aims to:
- Streamline clinical trial processes
- Enhance harmonisation across EU Member States
- Support innovative trial designs, including decentralised approaches
| New documents | Purpose of document |
| Recommendations on criteria regarding the selection of a reporting Member State | This document provides Member States with recommendations on criteria for the selection of the Reporting Member State (RMS). |
| Updated documents | |
| Recommendation paper on decentralised elements in clinical trials | Addresses the roles and responsibilities of the sponsor and investigator, electronic informed consent, IMP delivery, trial related procedures at home, data management and monitoring in a decentralised clinical trial setting. The paper includes an overview of the current national provisions applicable in each Member State. |
| Recommendation paper on frequent issues for Part I and Part II in clinical trials | Provides a curated list of some of the most frequent and relevant considerations raised during the evaluation of Part I of CTA. |
| Auxiliary medicinal products in clinical trials | Clarifying requirements for auxiliary medicinal products (AxMPs) used in clinical trials including the definition and examples of types of AxMPs. |
Sponsors and stakeholders should review these documents to ensure compliance and optimise trial planning
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