Abstract
The centralised clinical trial authorisation process, introduced by European Regulation 536/2014, came into force on 31 January 2022. The Regulation is inflexible, both legally and in the technical detail of the authorisation process itself. The principal justification for moving away from the older European Directive 2001/20 seems to be limited to multinational trials: multiple applications to national competent authorities (NCAs), would theoretically be replaced by a single, internationally harmonised authorisation. In fact, the Regulation itself reserves many powers to the NCAs, and the latter, in any case, can lawfully impose further requirements even after that harmonised approval; the year's experience reflects these disadvantages. It would have been better if Regulation 536/2014 had been written to allow the European Medicines Agency greater flexibility, and offered an alternative, optional approach to clinical trial authorisation in the European Union.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
