European Union Directive clinical trials

European Union, Clinical Trials Directive (2001/20/EC), Official Journal of the European Communities L121, pp34—44, 2001. 

Boyce M, Warrington S. Analysis of 312 studies of investigational medicinal products in healthy subjects to assess the impact of European Union Clinical Trial Directive. Int J Pharm Med 2002 16 179-184. 

Hence, the standards for conducting clinical trials must be known before they can be applied. Standards are either international (e.g. ICH GCP), European (e.g. European Union Clinical Trials Directive (2001) and GCP Directive (2005)), national (i.e. national drug laws and GCP regulations) or even more local, such as State laws in the United States (Isidor and Kaltmann, 1999). Apart from the regulations, the clinical trial protocol, SOPs and other internal or external instructions document procedures how the trial should be carried out from start to finish. Compliance with these standards is expected. 

The FDA has clarified the minimum requirements for an IND submission in three areas chemistry, toxicology reports (draft) and size (2-3 volumes, each 3" thick) in an attempt to relax current practices somewhat, to the level required for a UK CTX. However, full reports are to be provided within a short time after the initial drafts. (Conversely, however, information needed to conduct human studies in the European Union has increased, recently, with the implementation of the Clinical Trial Directive.)... 

Clinical trials and clinical trial authorizations in the European Union are controlled under the Clinical Trial Directive, 2001/20/EC [9], and all member states are bound by its requirements. Under the provisions of the Directive, a clinical trial is an investigation in human subjects that is intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism, and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies. 

With a view to harmonising the conduct of clinical trials across the European Union, Directive 2001/20/EEC was finally agreed on 14 December 2000 and was formally adopted in May 2001 with a 3-year transition period for its implementation. The Directive is now fully implemented in the United Kingdom and further information on clinical trials there can be accessed at the MHR A website. Under the provisions of the Directive, all clinical trials now require a Clinical Trial Authorisation (CTA). This is discussed in detail in Chapter 17. 

Compliance with the requirements of Directive 2001/20/EC is important. This is because Annex I to Directive 2001/83/EC (as amended) expressly requires that for the purpose of obtaining a marketing authorization, all clinical trials conducted within the European Union to comply with Directive 2001/20/EC. For clinical trials conducted outside the European Union and the data of which are used in support of an application for a marketing authorization, such clinical trials must be designed, implemented, and reported on the basis of principles that are equivalent to the provisions of Directive 2001/20/ EC and carried out in accordance with the ethical principles that are reflected in the Declaration of Helsinki. 

Directive 2001/20/EC, which mainly concerns approval of clinical trials in the European Union. 

With a view to harmonising the controls on clinical trials, a draft Directive concerning the conduct of clinical trials in the EU was submitted to the European Parliament by the Commission in September 1997. After three years of difficult negotiations, a EU Directive aimed at harmonising the requirements for clinical trials in the European Union was finally agreed on 4 April 2001 by the European Parliament and Council and formally adopted in May 2001 with a three-year transition period for its implementation by 1 May 2004. 

The European Union Directive on Good Clinical Practice in Clinical Trials Implications for Future Research... 

European Parliament and the Council of the European Union (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. (http //pharmacos.eudra.Org/F2/eudralex/vol-l/DIR 2001 20/DIR 2001 20 EN.pdf)... 

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