WHAT IS THE AIM OF THE DIRECTIVE?
This directive sets out basic principles for conducting clinical trials of medicinal products. Its aim is to ensure the quality of clinical trials by respecting human rights and human dignity.
KEY POINTS
This directive concerns clinical trials of medicinal products including multi-centre trials. It does not apply to studies where medicinal products are prescribed in the usual way.
Protection of clinical trial subjects
The trial subjects are protected. On the one hand, a clinical trial may only be carried out if the risks to the subject are in proportion to the potential benefits of the medical research. On the other hand, the right of the subject to physical and mental integrity must be respected, as well as the right to privacy.
The medical care given to the subjects and medical decisions made on their behalf are the responsibility of an appropriately qualified physician.
Trial subjects are to be provided with a contact point, where further information can be obtained.
Role of the Ethics Committee
In preparing its opinion on clinical trials, the Ethics Committee must take a number of factors into consideration, in particular:
- the relevance of the trial and the trial design;
- the protocol;
- the suitability of the investigator (i.e. the person responsible for performing the clinical trials on a site) and his or her supporting staff;
- the quality of the facilities.
The Ethics Committee’s opinion must be delivered before the start of the clinical trials.
EU countries must set up a procedure which will deliver a single Ethics Committee opinion for each EU country, including the case of multi-centre clinical trials.
Conducting a clinical trial
The directive describes the conditions and time limits to be respected in order to begin a clinical trial.
The sponsor (i.e. the person, firm, institution or body responsible for setting up, managing and/or funding the clinical trial) must, within 90 days of completion of the clinical trial, duly inform EU countries.
EU countries on whose territory the clinical trial is performed must enter data extracted from the initial request, amendments as appropriate, and the notification at the end of the clinical trial, into a database.
The European Medicines Agency may, exceptionally, make part of the information entered in this database available to the public.
A EU country must immediately inform the other EU countries and the European Commission whenever:
- it suspends or prohibits the trial because the conditions set out in the application cease to be met or because doubts arise as to the safety or scientific justification of the trial;
- it is of the opinion that the sponsor or investigator is no longer fulfilling their obligations.
Manufacture and import of investigational medicinal products
The manufacture and import of investigational medicinal products is subject to the authorisation referred to in this directive.
The particulars to appear on their outer packaging or, where there is no outer packaging, on their immediate packaging, must be published by the Commission in the good manufacturing practice guideline on investigational medicinal products to be adopted.
Compliance with good clinical practice
EU countries must appoint EU inspectors. These inspectors carry out inspections on behalf of the EU at relevant sites, notably trial sites and manufacturing sites, in order to check compliance with the provisions of good clinical practice. An inspection report must be prepared.
The European Medicines Agency is responsible for coordinating inspections.
Inspections may be carried out in a third country, where there are agreements between the EU and the third country.
Notification of adverse events
The investigator must immediately report all serious adverse events to the sponsor, except for any listed in the protocol or in the investigator’s brochure as not requiring immediate reporting.
Adverse events and abnormalities identified in the protocol as critical to safety evaluations must be reported to the Ethics Committee and the sponsor. In the event of the death of a subject during a clinical trial, the investigator must supply the sponsor and the Ethics Committee with any additional requested information.
The sponsor:
- must ensure that all the relevant information about adverse events are reported to the EU country concerned within the time limits;
- must maintain detailed records of all suspected adverse events, which must be submitted to EU countries in whose territory the clinical trial is being carried out.
In the event of suspected serious unexpected adverse reactions to an investigational medicinal product occurring on its territory, the EU country must ensure that this event is reported to the European Medicines Agency, which must inform the competent authorities of the other EU countries.
The directive is without prejudice to the general civil and criminal liability of the sponsor or the investigator.
Repeal
Directive 2001/20/EC will be repealed by Regulation (EU) No 536/2014 (see summary).
FROM WHEN DOES THE DIRECTIVE APPLY?
It had to become law in the EU countries by 1 May 2003. EU countries had to apply the rules as of 1 May 2004.
BACKGROUND
For more information, see:
MAIN DOCUMENT
Directive 2001/20/EC 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 (OJ L 121, 1.5.2001, pp. 34-44)
Successive amendments to Directive 2001/20/EC have been incorporated in the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, pp. 1-19)
See consolidated version.
