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The Necessity of the Amendment for the Drug and the Medical Device Definition Clauses in order to Design the Premarket Allowance Pathway for Combination Products
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융복합 의료제품 규제를 위한 의약품과 의료기기 정의규정의 개정 필요성과 그 방향

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Type
Academic journal
Author
Seunghan Oh (아주대학교)
Journal
Center for Law & Public Utilities Journal of Law & Economic Ragulation Vol.15 No.2(Wn.30) KCI Accredited Journals
Published
2022.11
Pages
141 - 167 (27page)

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The Necessity of the Amendment for the Drug and the Medical Device Definition Clauses in order to Design the Premarket Allowance Pathway for Combination Products
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Recently, drug-device combinations, such as ‘a drug eluting stents’ and ‘transdermal patches’, become more important and are growing as efficient alternatives of traditional therapies. The combination products are defined as the products, which are composed of two or more of the traditional medicinal products, drug, device, and biologic. All combination products, however, consists of at least two distinct constituents, unlike other traditional medicinal products.
In the current premarket allowance pathway for the drugs and devices, it is unclear whether the combination products are regulated as drugs or devices. Although publicizing the guidelines and the regulatory notices for the handling process of ‘the market application for combination products’, the Ministry of Food and Drug Safety (MFDS), actually, has no authority of making criteria to allocate them into the drug, the medical device, or the biologic pathway. None of laws regulates the definition of combination products and the standard to classify them, which are answer for what kinds of requirements are required to get market allowance.
The most problematic hurdles in designing the appropriate regulation pathway for combination products are the definitions of a drug (including a biological product) and a device, which are stipulated in separate legislations, the Pharmaceutical Affairs Act (PAA) and the Medical Devices Act (MDA), respectively. The current PAA specifically defines ‘the drugs’ with exception of device and MDA also specifies ‘the devices’ as distinct from drugs. As a result, in the current Korean medical statutes, the definitions of drug and device are mutually exclusive; therefore, PAA should be applied to only the drug portion of the product, and MDA device law also should be applied to only the medical device.
For this reason, whether the combination products composed of both drug(biologic) and medical device should be regulated as a drug, a biologic or a device, sometimes, has not been decided and delayed. In order to remove this regulation gap, the amendment of the definition articles for drug and device in PAA and MDA is not avoidable.
#융복합의료제품(Conglomerate Medicinal Products) #의약품정의(the Drug Definition) #의료기기의 정의(the Medical Device Definition) #조합상품(Combination Products) #생물의약품(Biologic Products)

Contents

국문초록
Ⅰ. 서론
Ⅱ. 융복합 의료제품과 현행 의약품 · 의료기기 규제체계의 문제
Ⅲ. 현행 약사법 및 의료기기법 체계와 융복합 의료제품의 규제
Ⅳ. 한국 약사법과 의료기기법상 정의규정의 개편 제안
Ⅴ. 결론
참고문헌
ABSTRACT

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