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.

When Was the clinical trial directive introduced?

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.

Are EU directives legally binding?

Article 288 A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods. A decision shall be binding in its entirety upon those to whom it is addressed.

What are the main types of European legislation?

The five EU legal instruments specifically provided for in the Treaties are: Regulations, Directives, Decisions, Recommendations and Opinions.

What is the difference between ICH and GCP?

ICH-GCP states that the monitor should be the one to verify the legibility of documents, while Indian GCP states that the monitor also needs to inform the Sponsor and Ethics Committee for any violations from the protocol.

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.

Why are clinical trial regulations important?

It aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials. The key benefits of the Regulation include: increased transparency of information on clinical trials; highest standards of safety for all participants in EU clinical trials.

What does ICH GCP mean?

Good Clinical Practice
Acronym. Definition. ICH-GCP. International Conference on Harmonisation-Good Clinical Practice (Food and Drug Administration guideline)

Is directive mandatory?

As adjectives the difference between directive and mandatory is that directive is that directs while mandatory is obligatory; required or commanded by authority.

What was the Directive 2007 / 46 of the European Parliament?

Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (Text with EEA relevance) (repealed)

What was the directive of 10 June 2002?

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (Text with EEA relevance)

What was the date of the Framework Directive?

Date of the OJ. 2007/46/EC. EP & Council. Establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive)

When did the EU food supplement Directive come into force?

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (Text with EEA relevance) In force: This act has been changed.