CLINICAL TRIALS REGULATION (EU) 536/2014 IMPLEMENTATION TRAINING
Last month, The European Commission, Clinical Trials Facilitation and Coordination Group and European Medicines Agency (EC-DG SANTE/HMA-CTFG/EMA) imparted a joint training on the Clinical Trials Regulation (EU) 536/2014.
The implementation to a European level implies a Harmonization of the submission of a clinical trial from all Member States of the part I documentation: documentation to be reviewed by Health Authorities, as well as part II documentation: documentation to be reviewed by Ethics Committee. The submission will be performed to the Reporting Member State selected by the sponsor but all documentation will be evaluated by the Reporting Member State and the others involved Member States.
In order to comply with transparency principle of the regulation, a new platform called Clinical Trial Information System (CTIS) will be available to submit and publish clinical trial information and documentation. EU portal is included in this platform. All submissions will be performed through the EU portal in which will be necessary registration.
The Clinical Trials Regulation (EU) 536/2014 and all new functionalities are foreseen to become applicable at the end of January 2022.
Complete training documents are available at EC-DG SANTE/HMA-CTFG/EMA joint training on the Clinical Trials Regulation (EU) 536/2014 | Public Health (europa.eu)