국내 융복합 의료제품의 허가에 관한 규제 체계 고찰
A Study on the Regulatory framework for approval of Combination products in Korea
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초록
기술의 발전에 따라 기존의 의약품, 의료기기, 의약외품 등의 제품으로 쉽게 구분하기 어려운 융· 복합적인 구성과 용도를 가진 새로운 의료제품이 개발되고 있다. 이와 같은 새로운 의료제품 중 의약품(drug)-의료기기(device), 생물의약품(biologics)-의료기기(device), 의약품(drug)-생물의약품(biologics), 또는 의약품(drug)-생물의약품(biologics)-의료기기(device)가 조합된 제품과 같이 두가지 이상의 상이한 개념의 제품들이 복합 또는 조합된 것을 내용으로 하는 ‘융복합 의료제품’에 대한효율적이고 합리적인 안전성 관리를 위한 법제도적 기반 마련이 요구된다. 이에 국내법상 융복합 제품의 개념과 허가 절차에 관한 규제 체계를 살펴 보고, 미국의 최근 개정 법률과 비교하여 문제점을찾아보고 향후 개선 과제에 대하여 생각해보았다.
Abstract
With the progress of technology, new medical products are being developed that have a combined composition and use that cannot be easily classified into existing medicines, medical devices, and quasi-drugs. Among these new medical products, drugs-medical devices, biologics-medical devices, drugs-biologics, or drugs-biologics, it is necessary to establish the legal basis for efficient and rational safety management for combination medical products, which are combined products of two or more different types. I would review the current status and problems of the definition and licensing process for combination medical products under domestic legislation comparing newly amended law in US, and suggest legislative tasks for improvement.
참고문헌 (4)
- Information book for combination products development, "Information book" (2019), Ministry of Food and Drug Safety
- "Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff, Draft guidance. Office of Combination Products, Center for Drug Evaluation and Research,Center for Devices and Radiological Health, Center for Biologics Evaluation and Research", ~
- "$177.7 Billion Drug Device Combination Products Market by Product & Region - Global Forecast to 2024" (2019)[URL]
- Study on establishment of the safety regulatory framework for advanced therapy medicinal products based on biotechnology, , Seoul national university college of medicine, ~ (2015)