Implementation of the Clinical Trials Regulation

Progress on CTR implementation

Under ACT EU, the European medicines regulatory network (EMRN) publishes statistics on the authorisation of clinical trials in the European Union (EU)/European Economic Area (EEA). This information provides an insight into how the CTR is transforming the clinical trial environment in the EU/EEA.

The reports are based on data retrieved from the Clinical Trials Information System (CTIS).

Implementation progress reports

Targeted surveys collect feedback from clinical trial sponsors on their experience with the implementation of the CTR and the use of CTIS. 

Summary reports of past surveys are available:

• Report on the 2023 survey on the implementation of the Clinical Trials Regulation
• Report on the 2022 survey on the implementation of the Clinical Trials Regulation

Materials to support clinical trial sponsors

The CTIS sponsor handbook is the reference document for clinical trial sponsors using CTIS. 

A stakeholder focus group, created under the ACT EU Multi-Stakeholder Platform, reviewed and validated the handbook to ensure it meets the needs of the sponsor community. 

EMA website: CTIS Handbook for sponsors

ACT EU has also published a recommendation paper with frequent issues identified during assessment of Part I and Part II. This practical tool helps sponsors anticipate and address common concerns proactively, accelerating the start of trials.

EC website: Frequent issues in Part I and Part II assessments

Transparency in CTIS

The revised CTIS transparency rules became applicable on 18 June 2024, with the launch of a new version of the CTIS public portal. 

Additional materials are available to support sponsors in the implementation of the revised rules:

• The quick guide for users which provides a summary of what will be published when under the revised rules;
• The Guidance document on how to approach the protection of personal data and commercially confidential information while using CTIS and Annex I which provides an overview of the types of data and documents submitted to CTIS that are subject to publication;
• The Q&A on the protection of commercially confidential information and personal data while using CTIS;
• The materials from the CTIS Bitesize talk on the revised transparency rules on 20 June 2024.

Related documents