The new regulation aims to harmonise the processing of clinical trials within Europe, as well as create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Clinical Trial Regulation will replace the Clinical Trials Directive 2001/20/EC once the Regulation has come into force.
The harmonisation of clinical trial application process will involve several administrative changes for both the applicants as well as regulatory authorities. This includes the submission of the application to both the Norwegian Medicines Agency and the Ethics Committee via a new EU portal, also called CTIS (the Clinical Trial Information System). The applicant will receive a joint decision after the assessment of the application has been completed. CTIS will be used throughout the life cycle of a clinical study including amendment notifications, reporting and inspection.
Applications for clinical trials with GMO drugs must be applied for via the old procedure, even after the regulation has come into force.
The Norwegian Medicines Agency is in the process of preparing for the transition to the new regulation. Relevant information will be published on this page from time to time You can also find updated information about the new portal and regulation on the EMA's webpage, as well as on the European Commission's webpage.