Lee So-young, Minister of the Ministry of SMEs and Startups, stated on October 16 that "four key industrial sectors have been selected for small and venture businesses to thrive, one of which is pharmaceuticals and biotechnology." She added that the ministry plans to establish an organization to identify its role in these sectors.
During a meeting at Organoid Science, a participant in the Advanced Regenerative Bio Global Innovation Free Zone in Cheongju, she emphasized that eliminating regulations that hinder corporate growth is a more effective policy than providing research and development (R&D) or financial support. She pledged to enhance the system to ensure that the practical demonstrations in the regulatory free zone lead to substantial regulatory improvements.
Minister Lee further remarked, "The regulatory free zone and regulatory sandbox systems should not only assist in demonstrations but also efficiently facilitate regulatory adjustments, and I believe the ministry should play a role in this regard."
The Global Innovation Regulatory Free Zone is a system that grants regulatory exemptions to companies in emerging industries facing challenges due to domestic regulations, while also supporting overseas demonstrations and certifications. Unlike general regulatory free zones, it features support for overseas local demonstrations and joint research and development, utilizing overseas demonstration results for domestic regulatory improvements.
The Cheongju Advanced Regenerative Bio Global Innovation Free Zone spans 941 square kilometers and will involve 35 institutions, including advanced bio venture companies and hospitals, from June 2024 to May 2028. The zone will promote operations for overseas demonstrations of advanced regenerative bio, support commercialization, and establish an ecosystem for the advanced regenerative bio industry.
Advanced regenerative bio refers to innovative treatment technologies that integrate cell therapy, gene therapy, and tissue engineering to regenerate and restore bodily structures and functions or to treat and prevent diseases.
Regulatory exemptions have allowed for the establishment and operation of a local review committee in Chungbuk for clinical research in advanced regenerative medicine. In August, a study on autologous blood lymphocytes reviewed by the Chungbuk committee became the first to receive central approval.
Yoo Jong-man, CEO of Organoid, pointed out the need for rationalizing entry requirements for mid-to-high-risk research in the clinical research sector and clarifying pathways for treatment utilization post-research to foster the development of the Advanced Regenerative Bio Global Innovation Free Zone.
Meanwhile, attendees at the meeting suggested financial support and regulatory improvements for bio companies seeking to expand overseas. Oh Sang-hoon, CEO of Organoid, emphasized, "For bio companies to survive, entering the global market is essential. However, the costs associated with overseas expansion are substantial, so government support must be expanded to help overcome funding challenges before commercialization."
Additionally, they proposed a plan to invest in bio companies achieving results in collaboration with Japanese pharmaceutical firms by using technology as collateral. They also requested that relevant ministries recognize the regulatory challenges faced by companies, which hinder the advancement of projects in the free zone, and develop institutional solutions to address these issues.
* This article has been translated by AI.
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