On January 31, 2022, the new European Medicines Agency (EMA) Clinical Trials Regulation (Regulation (EU) No 536 / 2014) comes into effect according to the 13 July 2021 Commission Decision as published in the Official Journal of the European Union. The aim of the regulation is “to ensure that, throughout the Union, clinical trial data are reliable and robust while ensuring respect for the rights, safety, dignity and well-being of subjects, …” (EMA 2021).
Applicability
Per Article 1, the regulation applies to all clinical trials conducted in the EU, but does not apply to non-interventional studies (EMA 2021).
What is the CTIS?
The new EU No 536/2014 regulation “harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS)” (EMA 2021). The CTIS is a single portal and database for clinical trials governed by the new regulation.
Per the regulation, the CTIS database should (EMA 2021):
- Contain all relevant information as regards the clinical trial submitted through the EU portal
- Be publicly accessible
- Should present data in easily searchable format
- Link related data together by the EU trial number
- Should not contain personal data from participating individual data subjects
The EMA maintains the CTIS (EMA 2021).
For the regulation to come into effect, the CTIS had to achieve full functionality and the systems had to meet the functional specifications published by the EMA (EMA 2021). This was completed and confirmed by an independent audit in April 2021, which then gave six months’ notice that the regulation would come into application (Official Journal of the EU).
Transition Period
The regulation replaces the existing EU Clinical Trials Directive (EC) No. 2001/20/EC. The new regulation includes provisions to facilitate the transition to the new requirements (EMA 2021).
