Following consultation with the Multi-stakeholder platform Advisory Group, new documents have been published to support sponsors in the implementation of the Clinical Trials Regulation (CTR).
Frequent issues in Part I & Part II assessments
Sponsors preparing clinical trial applications can now consult a new recommendation paper on frequent issues identified during assessment of Part I and Part II.
This practical tool helps sponsors proactively address common concerns to accelerate the initiation of trials.
Decentralised elements in clinical trials
An updated version of the recommendation paper on decentralised elements in clinical trials is now available.
It includes a new statement about cross-border trials and an updated overview of national provisions.
Decentralised elements aim to facilitate participation in clinical trials by increasing flexibility and convenience for researchers and patients.
Auxiliary medicinal products (AxMPs)
The Clinical Trials Coordination and Advisory Group (CTAG) has released updated recommendations on the use of auxiliary medicinal products (AxMP) in clinical trials.
Effective from 1 December 2025, the revised document provides additional clarifications and examples.
AxMPs are medicinal products used in clinical trials, for example to assess endpoints, but not as investigational medicinal products.
Details
- Publication date
- 31 October 2025
- Author
- European Medicines Agency
