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 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 adopts ...

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 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 Harmonisation of Technical Requirements ...

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 a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before thei ...

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

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been de ...

, 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 participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...

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.

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 An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law. Specific regions An ethics committee in the E ...

* 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 An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...

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 is considered to have increased the costs of doing clinical trials in the EU, and to have caused the reduction in the number of such trials,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.http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp&mid=WC0b01ac05808768df

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