Clinical trials - Directive 2001/20/EC

General information

Requirements for the conduct of clinical trials in the EU are provided for in " Directive 2001/20/EC 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) 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) ").

The Clinical Trials Directive is concretised further by " Commission Directive 2005/28/EC pdf(263 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) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" (Good Clinical Practice - " the GCP Directive pdf(263 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) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) ").

Directive 2001/20 EC will be repealed on the day of entry into application of the new Clinical Trials Regulation.  It will however still apply three years from that day to:

  • Clinical trials applications submitted before the entry into application (no earlier than 28 May 2016)
  • Clinical trials applications submitted within one year after the entry into application if the sponsor opted for old system.

Guidelines

The Commission has issued guidance documents in order to ensure a uniform application of the legislation on clinical trials in Europe. The guidelines specify in particular:

  • The information to be submitted to the competent authorities and to the ethics committees
  • The requirements on safety monitoring and the reporting of adverse reactions
  • The requirements regarding Good Clinical Practice, including the documentation, of the clinical trials
  • The specific requirements regarding the products and the clinical trials
  • The inspections of competent authorities and the applicable procedures

All 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.  

Application for the authorisation of Clinical Trials

The Clinical Trials Directive harmonises the rules in the EU for the approval of a clinical trial conducted in a Member State. As regards national competent authorities, the details are set out in the 'Commission Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)pdf(1022 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) ' published in EudraLex Volume 10.

EudraCT

A European database - EudraCT - contains all ongoing or completed clinical trials falling within the scope of Directive 2001/20/EC, i.e. with at least one investigator site in the EU (incl. the European Economic Area) and commencing after implementation of Directive 2001/20/EC by the Member States. This database gives the competent authorities of the Member States, the EMA and the Commission the necessary information to communicate on clinical trials and to maintain oversight of clinical trials and IMP development. This provides for enhanced protection of clinical trial subjects and patients receiving IMPs. More information, including a user manual for EudraCT is available on the EudraCT Supporting Documentation web page.

 EudraCT also contains information on all trials performed anywhere in the world if the trial:

Transparency

Union legislation provides that certain information contained in EudraCT is to be made accessible to the public. This public accessibility concerns clinical trials with paediatric as well as non-paediatric participants. It englobes protocol-related information and result-related information. And it covers both negative and positive results.

To implement the legislation further, the Commission has issued a set of guidelines, which are accessible via chapter V of EudraLex, Volume 10.

These guidelines consist of three "mother guidelines" (Guideline 2008/C168/02; Guideline 2009/C28/01, Guideline 2012/C302/03), setting out the principles, responsibilities, and procedural aspects. The "mother guidelines" are further concretised by way of a number of very detailed "daughter guidelines" :

With regard to protocol-related information, this information is public under clinicaltrialsregister.eu, which is part of the public database EudraPharm.

As of 21 July 2014, the clinical trial results posted by sponsors in the EudraCT line with the Guideline 2012/C302/03 will become available to the public. This date corresponds to the finalisation of the programming of the database as referred to in a European Commission guideline pdf(774 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) , in application of the current clinical trials 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) and the Paediatric Regulation.pdf(307 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)

What this means for clinical trial sponsors

Results for any trials registered in EudraCT will be posted in this database. This will apply:

  • For any clinical trials that ended on or after 21 July 2014, sponsors will have to post results within six (for paediatric clinical trials) or twelve months (for non paediatric clinical trials) following the end of the trial.
  • For trials that ended before 21 July 2014, the guideline sets the specific timeframe for the results submission.

What this means for public access to information on clinical trial  results

  • A subset of the data included in EudraCT is made available to the public in the European Union Clinical Trials Register, clinicaltrialsregister.eu. A typical set of summary results provides information on the objectives of a given study, explains how it was designed and gives its main results and conclusions. A number of summary results can already be viewed. Only the result related information on Phase I clinical trials on adults is not made public.
  • In addition, information on paediatric studies that ended before the Paediatric Regulation came into force in 2007, which used to be accessible through the EMA website, is now available through the European Union Clinical Trials Register. This improvement allows a greater and richer approach to the search and greater public access to clinical trial related information.

 For all additional information, please click here

Safety reporting

The Clinical Trials Directive sets rules on safety reporting in the context of a clinical trial. Further details are set out in 'the Commission Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use  published in EudraLex Volume 10. Regarding suspected unexpected serious adverse reactions (SUSARs), this guidance provides inter alia the rules for reporting directly to the national competent authority. In order to obtain the national address for the direct reporting, click on the relevant Member State:

    • Austria (mail or by fax to: Bundesamt für Sicherheit im Gesundheitswesen (BASG), Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES) PharmMed,  Institut Pharmakovigilanz, Schnirchgasse 9, A-1030 Wien, Österreich, Fax: +43 (0) 50555-36207),
    • Denmark,
    • Germany,
    • Greece,
    • Ireland,
    • Italy (susar-ita@aifa.gov.it),
    • Netherlands,
    • Portugal,
    • Sweden,
    • United Kingdom.

Clinical trials conducted outside the EU

 Contact points