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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 products for human use) is a European Union directive that aimed at ...
The European Union Clinical Trials Regulation (regulation (EU) No 536/2014) is the legislation relating to the conduct of clinical trials of investigational medicinal products within the European Union. The regulations repealed the previous legislation, namely the clinical trials directive and came into force on 31 January 2022. [1]
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3] A ...
Directive 75/319/EEC, requires marketing authorization 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; Directive 2001/83/EC
Article 57 of the Regulation requires that the TMF "shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated", confirming that the trial master file should be maintained contemporaneously.
(The Center Square) – The state of Texas has two more wins in court, in a sweeping small business federal regulatory action that a federal judge ruled is unconstitutional and a federal agency ...
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC.
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
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