The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the

European Parliament The European Parliament (EP) is one of the two legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it ...

and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of

good clinical practice In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for ...

in the conduct of clinical trials on medicinal products for human use) is a

European Union directive A directive is a legal act of the European Union that requires member states to achieve particular goals without dictating how the member states achieve those goals. A directive's goals have to be made the goals of one or more new or changed n ...

that aimed at facilitating the internal market in medicinal products within the

European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...

, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

s in the European Community, by establishing a clear, transparent procedure. The Member States of the

had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004. This Directive has been abrogated by Regulation 536/2014, dated April 16th, 2024, which took effect on January 31st, 2022.

The Articles of the Directive

The Articles of the Directive: * Scope (Directive does not apply to non-interventional trials). * Definitions * Protection of clinical trial subjects * Clinical trials on minors * Clinical trials on incapacitated adults not able to give informed legal consent * Ethics Committee * Single opinion * Detailed guidance * Commencement of a clinical trial * Conduct of a clinical trial * Exchange of information * Suspension of the trial or infringements * Manufacture and import of investigational medicinal products * Labelling * Verification of compliance of investigational medicinal products with good clinical and manufacturing practice * Notification of

adverse event In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medicati ...

s * Notification of serious adverse reactions * Guidance concerning reports * General provisions * Adaptation to scientific and technical progress * Committee procedure * Application * Entry into force * Addressees

The effects of the directive

It increased the costs of doing clinical trials in the EU, and a reduction in the number of such trials followed its implementation,The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly
/ref> especially of academic-led studies, and ones looking at new uses for old drugs.print and online Germany derogated from the directive. It is due to be replaced by the EU Clinical Trials Regulation in 2016. The changes are due to come into effect in the second half of 2019.

* EudraLex, the collection of rules and regulations governing medicinal products in the European Union * Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products * Directive 75/318/EEC, clarifies requirements of 65/65/EEC1 and requires member states to enforce them * Directive 75/319/EEC, requires marketing authorisation requests to be drawn up only by qualified experts * Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products * Directive 2001/20/EC, defines rules for the conduct of

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

* Directive 2001/83/EC * Directive 2005/28/EC, defines Good Clinical Practice for design and conduct of clinical trials *

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

Regulation of therapeutic goods The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are reg ...

* Investigator's Brochure

References

{{Reflist
EU information on the Clinical Trials Directive
European clinical research Pharmaceuticals policy European Union directives 2001 in law 2001 in the European Union

The Articles of the Directive

The effects of the directive

See also

References