Regulatory Science
Capacity Building
Product Commercialization Support & Networking
Background
- The government is actively investing in innovation-based R&D to activate the biohealth industry, and is continually increasing the amount of investments. The importance of collaboration between industry, academia, research institutes and government to promote the practical application of R&D results is growing.*Implementation of the Act on Regulatory Science Innovation for Supporting Food and Drug Safety and Commercialization. (Feb. 2024.), establishment of the Bio-Health Innovation Committee (Oct. 2024), Development Strategy for Biohealth Regulatory Science (Jun 2024), and the implementation of the Promotion Act for Food and Drug Safety Technology (May 2015)
- The role and importance of regulatory science as a bridge to quickly deliver innovative technology-applied products to consumers are emerging.
Purpose
To reduce regulatory risks and improve the success rate of commercialization throughout the R&D lifecycle of innovative food and drug products by providing mentoring of technology-regulation alignment and tailored regulatory support.
* Biohealth regulatory science development strategy (‘21.6), promulgation of the ‘Food and Drug Regulatory Science Innovation Act’ (‘23.8) and implementation (‘24.2)
Terminology
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What is the "Technology-Regulation Alignment Review"?
- It involves reviewing the alignment of new or innovative technologies used in product research and development with regulatory requirements to support commercialization.
- ▲Providing regulatory support such as product classification, determination of regulatory applicability, guidance on authorization procedures, and the scope of required submission materials when an understanding of regulatory alignment is needed during the R&D and early commercialization stages.
▲Identifying needs for quality and safety evaluation technologies and supporting regulatory science research when establishing regulations or evaluation technologies for innovative food and medical products throughout their R&D stages is required.
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Target
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Food, pharmaceuticals, biopharmaceuticals, medical devices, cosmetics, etc.
Supports
1Operation of a mentoring program for product commercialization support
- Providing guidance and consultations on product/item classification, relevant regulations, authorization procedures and regulatory review items for innovative products.* For early-stage R&D, including regulatory alignment mentoring and commercialization support (non-clinical, clinical, good manufacturing practices (GMPs)), and authorization procedures and requirements.
- Development and provision of basic regulatory education courses for researchers and developers conducting R&D
2Regulatory Alignment Support by the Ministry of Food and Drug Safety
- Providing consulting on the development of technology for regulatory science evaluation or commercialization based on the purpose, research content, and development stage of the R&D project to proactively support regulatory agencies* Implementing tasks assigned by the Ministry of Food and Drug Safety, such as “Operation of the Commercialization Support System, including Regulatory Alignment Review.”