The way clinical trials are conducted in the EU will undergo a major change with application of Regulation (EU) 536/2014.  The regulation, which was initiated by the European Parliament and the Council, came into force on 16 June 2014, will repeal Directive 2001/20/EC. The European Commission has officially confirmed 31 January 2022 as the date of entry into application of Regulation (EU) 536/2014 and the go-live of the Clinical Trials Information System (CTIS).

Regulation (EU) 536/2014 

harmonises the assessment and supervision processes for clinical trials throughout the EU, via CTIS. CTIS will contain the centralised EU portal and database for clinical trials foreseen by the regulation and will be the single entry point for clinical trial application submission, authorisation and supervision.

The European Medicines Agency’s (EMA) Sponsor Handbook provides clinical trial sponsors with the information which will assist them in the use of the CTIS. The Handbook which has been developed by the EMA in collaboration with various industry stakeholders provides a comprehensive guide on important topics, including the transition from the Directive 2001/20/EC to Regulation (EU) 536/2014, safety reporting obligations and data transparency.


For more details on clinical trials information, visit Axco Clinical Trials.