The first common regulatory framework on Clinical Trials (CT) in the European Union (EU) has been established in April 2001 following the adoption of the Directive 2001/20/EC (hereafter referred to as “the Directive”).

The scope of the Directive covered exclusively interventional CT on Humans involving medicinal products including advanced therapy medicinal products (ATMPs). The Directive was the first attempt to a harmonisation of the requirements for CT in EU, the principles of the Directives were then transposed by each Member State (MS) under national laws.

A few years after its implementation, in December 2008, the European Commission (EC) announced the assessment of the CT Directive, that led to the release in October 2009 of a public consultation paper.

Although it was acknowledged that the directive had a positive impact on the safety, ethic and reliability of data from CT conducted in EU, the Directive presented certain limitations in particular, it did not succeed to promote clinical research in Europe as evidenced by a decreased number of CT (decrease of 25% between 2007 and 2011).

Further limitations raised included the increased cost, the lack of harmonised regulatory requirements between MS, a regulatory framework not always adapted to practical requirements and the length of procedure leading to delays in CT start.

In addition to the rules laid down in the Directive, a voluntary procedure for a harmonised evaluation of CT application (CTA) between several MSs is possible under the Voluntary Harmonised Procedure (VHP). However, this procedure can be proposed only on a voluntary basis and is not integrated into a legal basis.

Furthermore, the VHP was, at this time, restricted only to the evaluation by the National Competent Authorities (NCA). A new regulatory framework was therefore deemed necessary with the aim of restoring the competitiveness in EU for CT conduct,by simplifying and harmonising the requirements.

In February 2011, a public consultation on a concept paper on the revision of the CT Directive was issued and in July 2012 the EC adopted the proposal for a CT Regulation.