What is EU Directive 2001?
What is EU Directive 2001?
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.
What is the EU Directive Regulation?
An EU directive is a legal act which requires member states to accomplish a particular set of goals without dictating the means to do it. In other words, it outlines certain rules which must be met, but each member state decides how to ensure compliance through national laws.
When was clinical trial Directive introduce?
April 2001with
The Clinical Trial Directive 2001/20/EC (CTD) was introduced in April 2001with theobjective of harmonizing clinical trial processes and detailing the legal provisions for GoodClinical Practice (GCP) in the EU.
What are the main types of European legislation?
EU legislation is divided into primary and secondary. The treaties (primary legislation) are the basis or ground rules for all EU action. Secondary legislation – which includes regulations, directives and decisions – are derived from the principles and objectives set out in the treaties.
How are clinical trials regulated in the UK?
∎ Clinical trials in the UK are currently regulated by the EU Clinical Trials Directive, which was transposed into UK law in 2004. The directive has been criticised for increasing the bureaucratic burden and cost of running trials in the EU.
What is the purpose of a directive?
Directive. A written issuance which serves to direct, guide, and/or generally impel a person or unit toward an action, attainment, or goal; a pronouncement urging, requiring, or prohibiting some action or conduct.
What is GCP in clinical trials?
Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects.
What is EU Clinical Trial directive?
The Clinical Trials Directive (Officially Directive 2001/20/EC 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 …
What are the 3 main GCP principles?
Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.
What does ICH GCP mean?
Acronym. Definition. ICH-GCP. International Conference on Harmonisation-Good Clinical Practice (Food and Drug Administration guideline)
When did the European clinical trials directive come into effect?
The Clinical Trials Directive (Officially Directive 2001/20/EC 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…
What was the directive of the European Parliament?
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
Is the EU Directive applicable to all member states?
Whilst an EU directive is open to individual member state interpretation, a regulation is uniformly applicable in all member states. An EU regulation does not require the implementation of legislation at a national level and so removes the potential for variations in interpretation between member states and leads to a fully harmonised approach.