Clinical trials - General information

 Introduction

Transition between Directive 2001/20/EC and Regulation EU No 536/2014

Guidelines

There are a number of guidelines further specifying various aspects of clinical trials.

These guidelines have been published by various bodies:

The guidelines for the application of Clinical Trials Directive can be found here.

The relevant guidelines and recommendations are now being revised and updated to be in line with the changes and requirements of the Clinical Trials Regulation.  

Revision of Clinical Trial Directive

Preparation of the Commission proposal

In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”, the Commission announced that an assessment would be made of the application of the Clinical Trials Directive.

This assessment considered, in particular, various options for improving the functioning of the Clinical Trials Directive with a view to making legislative proposals, if appropriate, while taking the global dimension of clinical trials into account.

In 2009, a public consultation document along this line was published herepdf(134 KB). The responses have been published here. A summary document of the responses is available herepdf(61 KB).

A 'roadmap' of the Commission impact assessment, setting out the main structure and the next steps, was made (available here.)

On 9 February 2011, a public consultation on a concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC (94 KB)pdf(94 KB) was launched. The concept paper presented:
- a 'preliminary appraisal' of which option appeared to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and
- the main figures used to evaluate the impacts of the different policy options.

The responses to this public consultation are published here. A summary of the responses is herepdf(95 KB).

Adoption of the proposal for a "Clinical Trials Regulation"

On 17 July 2012, the Commission adopted a "Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"pdf(767 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) Gaeilge (ga) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) (hereinafter "Clinical Trials Regulation") .

The adoption was announced in a press releasepdf(97 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) svenska (sv) , supported by a questions and answers pdf(64 KB) Choose translations of the previous link Deutsch (de) français (fr) document.

The Commission proposal was accompanied by an impact assessment report (Volume Ipdf(673 KB); Volume IIpdf(502 KB)) and a summarypdf(65 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) Gaeilge (ga) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) thereof.

In addition, a 'citizen summary'pdf(128 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) was published.

The proposal was submitted to the European Parliament and the Council who engaged in ordinary legislative procedure. You may find an overview of this procedure here. To follow the proposal in the different steps of the procedure, please consult the "legislative observatory" of the European Parliament or PreLex, the EU-database on interinstitutional procedures.

Adoption of the new Regulation on clinical trials

On 16 April 2014 the new Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECpdf(875 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) Gaeilge (ga) hrvatski (hr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) was adopted, and published in the Official Journal on 27 May 2014. It entered into force on 16 June 2014 but will apply no earlier than 28 May 2016.

Until then the Directive 2001/20/ECpdf(126 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) hrvatski (hr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use" (" the Clinical Trials Directive pdf(126 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) hrvatski (hr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) ") will still apply.

In addition, the transitory provisions of the Regulation offer the sponsors the possibility to choose between requirements of the Directive or the Regulation for 1 year from the entry into application of the regulation.