Clinical Trials - Update on the CTIS

The HMA (Heads of Medicines Agencies) Clinical Trials Coordination Group (CTCG) has summarized the experience of applicants and, in particular, national regulatory authorities with approval and amendment applications submitted via the CTIS in an FAQ paper. In addition, the German BfArM (Federal Institute for Drugs and Medical Devices) has now set up its own website with the most common (avoidable) deficiencies in the submission of an initial application or a major change. The BfArM lists the deficiencies that occur in the areas of validation, drug quality, preclinical and clinical trials. The agency recommends following the recommendations in order to avoid objections to the relevant points and thus enable a faster evaluation. Formal deficiencies are particularly common, but study-specific deficiencies in the trial protocol and deficiencies in the characterization of the change and in the area of safety are also frequently observed.

CTIS Clinical Trials Map

Since March 2025, an interactive map has been available that allows users to search for registered trial sites in Europe and the clinical trials they are conducting in the EU. It is integrated into the public CTIS portal and is an easy-to-use, patient-friendly dashboard that helps patients and healthcare professionals find planned, ongoing, and completed clinical trials in the EU. The graphical map of Europe has filters that make it easier to search for and find clinical trials and the people who run them.

The EMA's interactive EU Clinical Trials Map is now available in 26 European official languages. This is the agency's response to a suggestion by EU pharmaceutical associations to make this necessary function available.