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KMID : 0986720220300010141
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Korean Journal of Medicine and Law
2022 Volume.30 No. 1 p.141 ~ p.162
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A Study of advanced therapeutic drug (ATMP) regulatory systems : Focusing on the comparison of the regulatory system of the European Union and the United States
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Lee Chang-Kyu
Kim Joo-Hee
Kim Su-Dong
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Abstract
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Advanced Therapy Medicinal Products(ATMP) consists of a category of innovative and complex biological products most of which are pharmaceutical products requiring complex preclinical and clinical development. ATMP's permit review process has a number of issues including scientific and technical issues as well as the regulatory system. In particular product definition and its classification in the first stage of development are the first gateway to product commercialization. There is a wide regulatory framework in the EU and US from pharmaceuticals composed of chemicals to biological substances.
Although the criteria that must be met in both the EU and US to classify a medical product as an ATMP are similar the European Union provides a more detailed subcategory between these subcategories. There are several relevant considerations for all defined subcategories of ATMPs that may change product classification in the European Union and the United States. Legal and regulatory guidelines issued by the European Union and the United States show similarities and differences in the classification of ATMPs in the two regions.
In Korea the law on advanced regenerative medicine and advanced biopharmaceutical safety and support has been enforced since 2020. The definition and classification of advanced biopharmacy in our law still accepts European and American legislation and various concepts are mixed. For a rational definition and classification in the Advanced Regenerative Biotechnology Acts compliance with the regulatory system for the classification of advanced regenerative medicine and advanced biopharmacy must be examined and complemented.
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KEYWORD
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Advanced Therapy Medicinal Products, classification system, regulatory system, gene therapy medicinal product, somatic cell therapy medicinal product, tissue engineered product, Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products
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