The Regulation on Clinical trials on Medicinal Products for human use (Regulation (EU) No 536/2014 of the European Parliament and of The Council of 16 April 2014) has been published in the Official Journal of the European Union. This Regulation will replace the existing clinical trials Directive 2001/20/EC, and will be automatically incorporated into the national laws for all European Member States, becoming effective in mid-2016.
The Regulation aims to simplify procedures across Europe and reduce costs to reach easier cross-border cooperation in international clinical trials. This will foster European competitiveness and innovative capacity, facilitating the development of new medicines for patients.
The Regulation introduces the electronic Clinical Trial Application on an European portal. One application dossier must be submitted through a single submission portal to all the Member States concerned.
Notably, it establishes a new application and review concerned process for clinical trials across Europe: the ‘Reporting Member State’, that is the first Member State where the sponsor intends to carry out the Clinical Trial Application, draws up an ‘assessment report’ focused on the risk/benefit ratio and release the authorisation through the European portal. Then, in case of multi-national clinical trials, the other Member States are involved following a simpler procedure of assessment (‘Part II’) focused on national and ethical aspects.
Well-defined and strict timelines in the assessment procedure are introduced. The “tacit authorisation” set up by Directive 2001/20/EC has been maintained in order to ensure that timelines are adhered to.
The Regulation introduces the concept of the “low-intervention clinical trials” (i.e. Investigated Medicinal Products are used in accordance with the terms of the Marketing Authorisation or on evidence-based/published scientific evidence). For those trials, the Reporting Member State verifies at first whether the study is a ‘low risk trial’ on the basis of a risk-based approach; then a faster assessment procedure is foreseen.
In addition to these measures simplifying clinical trial approvals, the Regulation intends to improve the transparency on the conduct of trials, from their authorisation to the publication of results.
In fact, it will be mandatory for sponsors to provide detailed summaries of clinical trial data, including a plain-language summary, within one year of the termination of the clinical trial (e.g., last visit by the last subject or as otherwise defined in the protocol).
The final text of the Regulation adopted by the European Parliament and the Council is available on the Official Journal of the European Union