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KMID : 1142220080030010021
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Regulatory Research on Food, Drug & Cosmetic
2008 Volume.3 No. 1 p.21 ~ p.39
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A Study on the Foreign Regulations of Biological Medicinal Products - Comparative Analysis of Definitions and Scopes of Biological Medicinal Products -
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Choi Young-Hee
Kwon Kyeng-Hee
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Abstract
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‘Biological medicinal products’ are defined as drugs derived from humans or other organisms as the source material, or those obtained by biotechnology such as recombinant DNA procedures in contrast to the conventional drugs that are synthesized chemically. Biological medicinal products are expected to be the ‘hot items’ of the bioindustry, as evidenced by the increasing number of ongoing studies and developments related to them. Following the growth of the industry, countries with highly developed medicinal industries, including America and the European Union are actively instituting regulations to demonstrate the safety and efficacy of biological medicinal products. However, Korea is still making slow progress in formulating similar regulations. As a leader in the field of biotechnology, Korea has yet to define biological medicinal products and establish an adequate management system. Both will guarantee improvements of Korean public health and make Korean a leader in the medicinal industry of the coming bio-era. The present report is a comparative study about foreign definitions and scopes of biological medicinal products that we expect will serve as a reference for future developments in Korea. After we analyzed various documents related to biological medicinal products issued by regulatory agencies of America, EU, Canada, Australia, and Japan, and took professional advice; we characterized the definition and scope of biological medicinal products of each study country. As a result of this study, we found that the terminologies in use to refer to ‘biological medicinal products’ in our study countries are ‘biological product’, ‘biologics’, ‘biological drug’ and ‘biological medicinal product’. In general, we found that biological medicinal products are defined as drugs derived from humans or other organisms or those obtained through biotechnology. The scopes of biological medicinal products are vaccines, blood and plasma derived products, any biological substances of human or animal origin, biotechnology derived proteins, gene therapies, cell therapies. Both, the definition and scope were remarkably consistent in our study countries.
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KEYWORD
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Biological product, biologics, biological medicinal product, gene therapy, cell therapy
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