｢식품‧의약품 등의 안전 및 제품화 지원에 관한 규제과학혁신법｣의 입법평가와 가치 - 해외 및 국내 규제과학 관련 입법과 비교⋅분석을 중심으로 -

초록

Governments must ensure that safe food, drugs, and other products are supplied to the public. To ensure the safety of these products, science and evidence-based regulatory policies are essential throughout the entire cycle, from the approval stage to post-market safety management. Accordingly, regulatory science has been introduced in Korea, which covers technologies, standards, and approaches to safety management, from evaluating the safety, efficacy, quality, and performance of food and drugs to their approval and use. In addition, as a legal basis for developing regulatory science in Korea, the Act on Regulatory Science Innovation for Supporting Food and Drug Safety and Commercialization(hereinafter the Regulatory Science and Innovation Act) was proposed by amending all existing Act on the Promotion of Technology for Ensuring the Safety of Food and Drugs. This study analyses the history of the enactment and revision of the Regulatory Science and Innovation Act, the main contents of each provision, the legislative value of the Regulatory Science and Innovation Act, and the direction to be taken in the future. The core content of the Regulatory Science and Innovation Act is to establish the concept of regulatory science and introduce it into the law. The Act supports R&D projects to develop new evaluation technologies and standards for the safety and effectiveness of food and drugs, including innovative products. It lays the legal foundation for commercialization support to increase the success rate of commercialization from the early stages of product development and the training of related experts. It also clarifies the scope of regulatory science to include drugs, food, and hygiene products. Based on the Regulatory Science and Innovation Act, if regulatory science becomes the core of scientific evidence that can support the competitiveness of the food and drug industry, it is expected that the promotion of regulatory innovation will revitalize the food and drug industry and further expand the public's right to choose safe products.

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