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Current topic: Submission of the application

Clinical trials applications in accordance with the EU Regulation

The EU portal and database Clinical Trials Information System (CTIS) is maintained by the European Medicines Agency (EMA) . The portal is used to submit and process clinical trials applications.

Clinical trials in accordance with the EU Regulation will be submitted here. 

Instructions

Operating procedures of clinical trials
Operating Procedures 8.4.2022 (Regulation and Biobank)
The documents mentioned in the annex I of the Clinical Trial Regulation (536/2014) and other relevant documents regarding the assessment of the part II of the application dossier
Instructions On Reporting Financial and Other Arrangements Related to Clinical Trials (CTR 536/2014)