Currently, the whole world awaits implementation of Clinical Trial Regulation EU No. 536/2014by the European Medicines Agency (EMA). It comes in collaboration with the Member States and the European Commission. According to the recent update on the EMA website, the Clinical Trial Regulation will come into application in 2019 instead of October 2018.

The Goal of Clinical Trial Regulation EU No. 536/2014

The main objective of Clinical Trial Regulation EU No. 536/2014 is to have a single e-submission to all Member States via an EU portal for Clinical Trial Authorisation in European Union. This would permit to make a single application to the Clinical Trials Facilitation Group (CTFG) which will be evaluated in one procedure by the competent authorities of those Member States where the clinical trial will be carried out. Undoubtedly, such a process:
– fosters innovation by simplifying the clinical trial application process;
– increases transparency and efficiency of each clinical trial within the EU;
– and keeps the balance between public health protection and recognition of legitimate economic interests of sponsors.

Consequently, an introduction of such a regulation will facilitate and speed up the process of regulatory submission. EMA expects it to take approximately 60 days for approval under normal circumstances.

Accell strongly believes this innovation would make European Union an even more desirable and attractive market for global R&D. Implementation of such an ambitious project will take time, effort, patience, and testing from all sides involved in the process. However, simplification and unification of the regulatory procedure is a positive step towards more efficient clinical trials in EU.