Directive 2001/20/EC

Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001, of the European Parliament 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 the conduct of clinical trials on medicinal products for human use. The European Parliament ( Europarl or EP) is the only directly elected parliamentary institution of the European Union (EU Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation (ICH an international body that defines standards

This Directive aims at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in It seeks to simplify and harmonize the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure. In health care clinical trials are conducted to allow safety and Efficacy data to be collected for new drugs or devices

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

The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Ethics Committee, according to Directive 2001/20/EC, is an independent body in a Member State of the European Union, consisting of healthcare professionals and Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice' is a term that is recognized worldwide for the control and management An adverse event (AE is any adverse change in health or "side-effect" that occurs in a person who participates in a Clinical trial while the patient is receiving the A serious Adverse event (SAE in human Drug trials are defined as any untowardmedical occurrence that at any dose results in death is Life-threatening The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in The Member States had to apply these provisions at the latest with effect from 1 May 2004.

References

Directive 2001/20/EC of the European Parliament and of the Council. EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Directive 65/65/EEC1 was the first European pharmaceutical directive Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical pharmaco-toxicological and clinical standards and protocols Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the Directive 93/41/EEC of 14 June 1993 on the approximation of national measures relating to the placing on the market of high- technology medicinal products particularly those derived from Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use The Directive 2005/28/EC or Good Clinical Practice Directive of 8 April 2005 of the European Parliament and of the Council lays down principles and detailed guidelines for The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction The European Medicines Agency ( EMEA) is a European agency for the evaluation of medicinal products. The Investigator's Brochure (IB is a basic document which is required in a Clinical trial of a new drug (that is one not yet approved by regulatory authorities for sale together
Implementing texts for Directive 2001/20/EC

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See also

References