The implementation of the new European Union (EU) Clinical Trial Regulation will provide a unified portal and database for trial sponsors and regulatory agencies across the EU Member States, promising to bring greater regulatory convergence and efficiency to the clinical trial application process.
This paper, developed by Deloitte UK, provides a synopsis of the new regulation, including insights on timing, the advantages of preparedness and the impact that Brexit may have. It also provides guidance on how companies can set up a successful CTR program.
In 2014, the European Medicines Agency (EMA) released Clinical Trial Regulation EU No 536/2014 that builds on Directive 2001/20/EC and the ideals represented in the Voluntary Harmonization Procedure (VHP) by the Heads of Medicines (HMA) Clinical Trials Facilitation Group (CTFG). In March 2017, the EMA presented an elaborate view on the advantages of moving from the directive to the regulation and the pathway to implementation of the portal and database.
Once effective, this new regulation will drive efficiency through harmonization of the Clinical Trial (CT) application process across Europe, greater transparency in clinical processes and data, and enhanced safety and efficacy of drugs.
The new regulation has brought certain key changes to the clinical trial application process in the EU.
This analysis provides a synopsis of this new regulation introduced by EMA including insights on the timelines to be followed by companies for CTR compliance. It also discusses the impact Brexit may have on the clinical trial processes in the region and addresses the question of how existing trials that are simultaneously run in the UK and the EU might be managed moving forward, post-Brexit. It also provides guidance to pharma companies on setting up a successful CTR program.