Clinical trials - Directive 2001/20/EC
Clinical trials in the EU are governed by the Clinical Trials Directive. Introduced to simplify and harmonise the administrative provisions governing clinical trials in Europe, it will be repealed by the Clinical Trials Regulation, upon its application in 2019.
The Regulation will improve legislation to address the disharmonised interpretation of the Directive across EU countries, and the administrative and regulatory burdens it imposed on the conduct of clinical trials.
The Directive will however, still apply three years from the date of application of the Regulation to:
- Clinical trials applications submitted before the entry into application
- Clinical trials applications submitted within one year after the entry into application if the sponsor opted for old system
- Guidelines and recommendations on the application of the Clinical Trials Directive are published in Eudralex Volume 10.
A number of these have been revised and updated to bring them in line with the changes and requirements of the Clinical Trials Regulation. All relevant documents will be progressively updated.
Application for the authorisation of Clinical Trials
The Clinical Trials Directive harmonises the rules for the approval of a clinical trial conducted in an EU country. The details are set out in the Commission Detailed guidance published in EudraLex - Volume 10.
The EudraCT database contains details on all ongoing or completed clinical trials falling within the scope of the Clinical Trials Directive. It enables competent authorities from EU countries, the EMA and the Commission to access information, interact, and maintain oversight of clinical trials and investigational medical products (IMPs) development. This ensures enhanced protection to clinical trial subjects and patients receiving IMPs.
EudraCT also contains information on trials conducted elsewhere in the world where they are part of an agreed paediatric investigation plan (PIP), or sponsored by a marketing-authorisation holder involving the paediatric use of an EU approved medicine, in line with Article 46 of the Paediatric Regulation.
EU legislation requires that certain information contained in EudraCT be made accessible to the public. This is the case for clinical trials concerning paediatric as well as non-paediatric participants. It includes information on protocol and results.
Additional guidelines detailed in chapter V of EudraLex - Volume 10 consisting of three "mother guidelines" (Guideline 2008/C168/02, Guideline 2009/C28/01, Guideline 2012/C302/03), set out the principles, responsibilities, and procedural aspects of implementation. The "mother guidelines" are further concretised in detailed "daughter guidelines":
Clinical trial results posted by sponsors in the EudraCT, in line with the Guideline 2012/C302/03, are available to the public, since 21 July 2014. This is outlined in European Commission guideline, in application of the current clinical trials Directive 2001/20/EC and the Paediatric Regulation.
What this means for clinical trial sponsors
- For clinical trials that ended on or after 21 July 2014, sponsors will have to post results within six (paediatric clinical trials) or 12 months (non-paediatric).
- 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
- Some data included in EudraCT is available to the public in the European Union Clinical Trials Register, clinicaltrialsregister.eu.
- Information on paediatric studies that ended before the Paediatric Regulation came into force in 2007 is also available in the Clinical Trials Register.
For all additional information, please click here.
The Clinical Trials Directive sets rules on safety reporting in the context of a clinical trial. 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.
This guidance also provides rules for reporting suspected unexpected serious adverse reactions (SUSARs) to national competent authorities.
Clinical trials conducted outside the EU
Clinical trials conducted outside the EU which are submitted in an application for a marketing authorisation in the EU, must follow the principles equivalent to the provisions of the Clinical Trials Directive (cf. Annex I, point 8 of the Directive 2001/83/EC.