융복합 의료제품 규제를 위한 의약품과 의료기기 정의규정의 개정 필요성과 그 방향
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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초록
최근 의료산업 현장에서는 전통적인 의약품과 의료기기(의약외품)를 결합하여 기존 치료제보다 편의성은 물론 유효성⋅안전성 측면에서 더 나은 효과를 가진 의료제품이 등장하고 있고, 이것을 융복합 의료제품이라고 호칭한다. 융복합 의료제품은 의약품과 의료기기(의약외품)가 결합되어 각각의 구성부분이 모두 치료⋅처지⋅진단 등의 기능을 수행한다. 그런데 융복합 의료제품은 ‘의약품’과 ‘의료기기(의약외품)’를 중심으로 완전히 분리된 시판허가 기준과 규제절차를 운영하고 있는 현재의 의료제품 규제체제 안에서 양자 어느 곳에서도 속할 수가 없어서, 적용될 시판 검증기준과 규제절차 등이 불분명한 상황에 처해 있다. 식품의약품안전처는 현재 자체 내규에 불과한 민원규정, 민원인 안내서 등을 통해서, 최소한도로 융복합 의료제품의 인⋅허가 신청절차 및 규제절차, 인⋅허가 요건 등을 안내하고 있으나, 그 근거가 불명확하고 충분하지 않다. 따라서 상위법에 명확한 규제근거와 규제절차 등을 제정하여 융복합 의료제품에 대한 규제절차를 설정할 필요가 있는데, 이를 위해 의약품과 의료기기(의약외품)를 완전히 독립적이고 철저히 분리되는 상품으로만 간주하여 양자의 양립가능성을 전혀 인정하지 않고 있는 현행 약사법과 의료기기법의 ‘의약품’ 및 ‘의료기기(의약외품)’에 대한 정의규정의 개정이 필요하다. 이를 통해, 의약품과 결합된 의료기기가 사실상 의료기기로 인정될 수 없고, 의약품도 될 수가 없어서 어느 한 곳에도 속하지 못하는 규제공백을 해결할 필요가 있다.
Abstract
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.
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