EU Clinical Trials Regulation (536/2014) - Launch of the EU portal and new procedure for clinical trials from 31 January 2022
Regulation of the European Parliament and of the Council on clinical trials on medicinal products (536/2014), the EU Clinical Trials Regulation (CTR), was published in the Official Journal of the European Union on 27 May 2014. It is the law directly applicable in the Member States.
The Regulation transforms the national process for the evaluation of clinical trials into a common European prior authorization procedure.
The application of the Regulation (536/2014) and the Finnish Clinical Trials Act (983/2021) has begun on 31 January 2022. The EU portal and database (Clinical Trials Information System CTIS), maintained by the European Medicines Agency (EMA), has been launched for the evaluation of clinical trials.
The first three years of application of the Regulation are transitional period. If an application for an authorization for a clinical trial has been initiated before the application of the CTR, clinical trials will continue to be covered by the repealed provisions of the Medical Research Act (488/1999) for three years after the launch of the portal (31 January 2025). In this case, the Medicines Research Directive (2001/20 / EC) will still apply. In addition, between 31 January 2022 and 31 January 2023, the sponsor of a study may decide whether to initiate a pharmaceutical study in accordance with the repealed provisions of the Research Act, ie the Directive or the Regulation. The application of the Research Act during the transitional period is provided for in the entry into force provisions of the amended Clinical Trials Act (984/2021).
CTIS Information and applications
EMA Press Release 25 January 2022