earticle

영어

Regulatory science plays a vital role in ensuring the safety, efficacy, and quality of products in the food, pharmaceutical, and medical device industries while supporting their efficient commercialization. Major regulatory agencies in the United States, Europe, and Japan have implemented early-stage collaboration frameworks to facilitate the market entry of innovative products. In Korea, the amendment of the「ACT ON REGULATORY SCIENCE INNOVATION FOR SUPPORTING FOOD AND DRUG SAFETY AND COMMERCIALIZATION」 and the introduction of the Examination of Regulatory Coherence have established a legal foundation for strengthening commercialization support programs. This study compares and analyzes product commercialization support systems in Korea and other leading countries while assessing researchers awareness of regulatory coherence. The findings highlight the need for regulatory agencies to provide tailored guidance, develop proactive regulatory frameworks, and enhance communication with researchers. Expanding regulatory education, ensuring policy sustainability, and strengthening interagency collaboration are essential for improving Korea’s commercialization support system. Through these improvements, Korea can enhance the effectiveness of its regulatory science initiatives, ultimately accelerating the market entry of innovative research and development outcomes.