Good clinical practice

Under this Directive, the European Parliament and the Council are defining the principles and guidelines of good clinical practice (GCP) in line with the principles enunciated in the 1964 Helsinki Declaration.

ACT

Proposal for a European Parliament and Council Directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

SUMMARY

This Directive concerns clinical trials of medicinal products as defined in Article 1 of Directive 65/65/EEC, including multi-centre trials.
The Directive does not apply to non-interventional clinical trials.

All clinical trials, including bioavailability and bioequivalence studies, are to be designed, conducted and reported in accordance with the standard of good clinical practice.

The trial subjects are protected. On the one hand, a clinical trial may only be undertaken if the risks to the subject are not disproportionate 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.

In preparing its opinion on clinical trials, the ethics committee must take into consideration a certain number of elements, 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 supporting staff;
the quality of the facilities.

The ethics committee's opinion must be delivered before the start of the clinical trials.

Member States must establish a procedure by which a single ethics committee opinion must be delivered for each Member State, including the case of multi-centre clinical trials.

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 mounting, managing and/or funding the clinical trial) must, within 90 days of completion of the clinical trial, duly inform the Member States.

Member States 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 accessible only to:

the Member States;
the European Medicines Evaluation Agency;
the Commission.

The European Medicines Evaluation Agency can, by derogation, make part of the information entered in this database available to the public.

A Member State must immediately inform the other Member States and the 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 his obligations.

The manufacture and import of investigational medicinal products is subject to the authorisation referred to in Article 16 of Council Directive 75/319/EC. The particulars to appear on the outer packaging or, where there is no outer packaging, on the immediate packaging of investigational medicinal products, must be published by the Commission in the good manufacturing practice guideline on investigational medicinal products to be adopted.

The Member States must appoint Community inspectors. These inspectors carry out inspections on behalf of the Community 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 Evaluation Agency is responsible for coordinating inspections.

Inspections may be carried out in a third country, where there are agreements between the Community and the third country.

The investigator must immediately report all serious adverse events to the sponsor, except for those 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 participant in 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 Member State concerned within the time limits;
must maintain detailed records of all suspected adverse events, which must be submitted to the Member States in whose territory the clinical trial is being conducted.

In the event of suspected serious unexpected adverse reactions to an investigational medicinal product occurring on its territory, the Member State must ensure that this event is reported to the European Medicines Evaluation Agency, which must inform the competent authorities of the other Member States.

The Directive is without prejudice to the general civil and criminal liability of the sponsor or the investigator.

Medicinal products used in the course of clinical trials may not be sold, other than in exceptional circumstances.

REFERENCES

Act	Entry into force - Date of expiry	Deadline for transposition in the Member States	Official Journal
Directive 2001/20/EC	01.05.2001	-	OJ L 121 of 01.05.2001

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1901/2006	Thirty days following publication in the Official Journal	-	OJ L 378 of 27.12.2006

Last updated: 9.7.2007