Clinical Trial Regulation expected to apply from December 2021
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to go live in December 2021.
From that moment on, the Clinical Trial Regulation (CTR) will apply as well. CTIS is built for the implementation of the CTR and will become the central portal for the submission and review of research with a medicinal product in the European Union.
As soon as the CTR applies, a transitional period of three years will commence. In the first year of the CTR, research with a medicinal product may still be submitted in the current manner or via CTIS.