As from the 31st of January 2022, the EU Regulation for research involving Medicinal Products (Clinical Trial Regulation, CTR) was ratified.
Under this regulation, sponsors submit the application for the medical-ethical assessment of their research involving medicinal products via an EU web portal, the Clinical Trial Information System (CTIS).
More information about the application for a CTIS account and other practical matters regarding CTIS can be found in this Research Roadmap and on the page of the Clinical Monitoring Center (CMC)
Under this regulation, sponsors submit the application for the medical-ethical assessment of their research involving medicinal products via an EU web portal, the Clinical Trial Information System (CTIS).
More information about the application for a CTIS account and other practical matters regarding CTIS can be found in this Research Roadmap and on the page of the Clinical Monitoring Center (CMC)