Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.
Set of documents that are applicable to clinical trials authorised under the Clinical Trials Regulation (EU) No 536/2014
- Quick guide for sponsors - Regulation 536/2014 in practice
- Questions and Answers Document - Regulation (EU) 536/2014
Annex II of the Q&A provides the language requirements for part I documents. Annex III of the Q&A provides lists of Member States websites specifying national requirements and contact details for Part I and Part II application
Recommendation paper on decentralised elements in clinical trials |
| This recommendation paper (October 2025) was developed as priority action of the ACT EU initiative of the European Commission, the Heads of Medicines Agencies, and the European Medicines Agency. The document was endorsed by Clinical Trials Coordination and Advisory Group (CTAG). |
Recommendation paper on frequent issues |
| This recommendation paper (October 2025) was created as part of the Clinical Trials Coordination and Advisory Group (CTAG) priority activities and as part of the priority action of the ACT EU initiative of the European Commission, the Heads of Medicines Agencies, and the European Medicines Agency. The document was endorsed by Clinical Trials Coordination and Advisory Group (CTAG). |
