European Union Directive definitions

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. 

Table 5.1 reviews the primary U.S. and European Union (EU) GMP regulations with reference to that part of the validation life cycle where particular regulatory clauses can be addressed. The table is not definitive and is given as an illustrative example only. Like many other GCP, GDP and GLP regulations, there are few direct references within the GMP regulations to computer systems validation. For instance, 21 CFR 211 [1] has only one clause directly applicable to computer systems. 

The Data Protection Act 1998 was passed in order to implement a European Data Protection Directive. This Directive sets a standard for data protection throughout all the countries of the European Union, and the new Act was brought Into force In March 2000. The Act gives the following useful definitions ... 

Among the various definitions of food additives that can be found in international legislation and accords is the one adopted by the European Union (EU) in its European Community Directive 89/107/EEC of the Council of 21 December 1988 any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation. 

Official Journal ofthe European Union 29.10.2008, L 285/9 Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions. 

In the European Union (EU), chemicals are managed through the European Chemicals Bureau. The EU avoids the issues associated with defining specific concentrations that are safe in the workplace, and instead puts labeling codes on the product that convey the relevant information for users. A directive provides both the codes, and the definitions of each code, for classificiation purposes. For example, one chemical may have the following codes ... 

The Traws-Atlantic Business Dialogue (TABD) approved a position statement regarding dietary supplements in 2002. The TABD is a group of corporations that promote closer commercial ties between the European Union and the United States. This position statement established industrywide consensus on standards and definition of permissible claims, as well as defining what is necessary for substantiation of those claims. In keeping with the Foods Supplement Directive, the TABD dealt only with vitamins and minerals, with the understanding that some of the conclusions may be revisited when warranted for herbals, botanicals, or other dietary supplements. 

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