첨단치료 의약제품(ATMP)에 대한 규제체계 연구 : 유럽연합 및 미국의 규제체계 비교를 중심으로
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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첨단치료 의약제품(Advanced Therapy Medicinal Products : ATMP)은 혁신적 기술 기반 생물학적 제제의 범주로 구성되며, 대부분 복잡한 전임상 및 임상 개발이 필요한 의약제품이다. ATMP의 허가심사 과정은 과학적·기술적 문제뿐만 아니라 규제체계를 포함한 여러 가지 쟁점이 존재한다. 특히, 개발의 첫 단계에서의 제품 정의와 그에 따른 분류는 제품 상용화를 위한 첫 번째 관문이다. EU와 미국에는 화학 물질로 구성된 의약품에서 생물학적 물질에 이르기까지 넓은 규제체계가 존재한다. 의료제품을 ATMP으로 분류하기 위해 EU와 미국에서 충족되어야 하는 기준은 유사하지만, EU는 이러한 하위범주 사이에서 더 세부적인 하위 분류를 제시하고 있다. EU와 미국에서 제품 분류를 변경할 수 있는 ATMP의 모든 정의된 하위범주에 대해 몇 가지 관련 고려 사항이 있다. EU와 미국에서 발표된 지침은 두 지역의 ATMP 분류에서 유사점과 차이점을 보여준다. 우리나라에서는 2020년부터 「첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률」이 시행되고 있다. 아직 우리의 법에서의 첨단바이오 의약품의 정의와 분류는 유럽과 미국의 법제 등을 수용해 여러 가지 개념들이 혼재되어 있다. 이에 EU와 미국의 체계를 비교 분석해 첨단재생의료와 첨단바이오의약품의 구분과 각각의 시행령과 시행규칙, 행정규칙 규제체계의 부합 여부를 검토해 보완해야 할 것이다.
Abstract
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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