Legal and Scientific Considerations in Nonclinical Assessment of Biotechnology Products

Abstract

Nonclinical evaluation of biotechnology-derived products is no longer an academic pursuit in product development. The conduct of relevant nonclinical studies serves the purposes of regulatory compliance and managing potential risks that may be associated with the product or the process. While the legal framework for the regulation of biotechnology/biological products is administratively different between the United States and the European Union, the scientific principles underpinning the safety, quality, and efficacy of biotechnology-derived products are not markedly different. Technical guidelines already developed at the International Conference on Harmonisation have been helpful in addressing global development of biotechnology-derived products. At each stage of any drug development program, product liability risks arising from poor product design as well as regulatory requirements must be considered. This article also briefly addresses the European product liability law as it relates to nonclinical evaluation of biotechnology-derived products.

Keywords

Legal and scientific aspects Nonclinical testing Biotechnology products

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