Meeting with Pharmaceutical CEOs, O Yu-kyung, Head of MFDS, Says "Actively Supporting New Drug Development Through Regulatory Improvements"

2022 KPBMA Pharmaceutical Bio CEO Workshop
Innovation and Communication... Advancing Globally Together

On the 2nd, attendees are taking a commemorative photo at the '2022 Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Pharma Bio CEO Workshop' held at the Four Seasons Hotel in Gwanghwamun, Seoul.

[Asia Economy Reporter Lee Gwan-ju] Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety (MFDS), met with CEOs of the domestic pharmaceutical industry and stated that she would actively support new drug development through reasonable regulatory improvements.

On the morning of the 2nd, at the ‘2022 Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Pharma Bio CEO Workshop’ held at the Four Seasons Hotel in Gwanghwamun, Seoul, Commissioner Oh said, "It is a time when the path and innovation are needed for domestic new drugs to grow into global blockbusters," adding, "Under the standard of public reassurance, we will join the path to leap into a global industry through innovation and communication."

In particular, Commissioner Oh directly introduced the MFDS’s regulatory innovation direction in the pharmaceutical sector to the CEOs. The goal of regulatory innovation was set as ‘food and drug regulations leading international technology,’ with specific directions including ▲support for new growth and new technology industries ▲global regulatory systems ▲alleviation of public inconvenience and burdens ▲procedural regulatory improvements. First, in line with rapidly advancing new technologies, regulations will be designed to fit the characteristics of new-concept pharmaceutical technologies such as microbiomes and exosomes, and various policies will be prepared, including the establishment of the ‘Global Food and Drug Policy Strategy Task Force’ to support global market entry after approval.

She also promised to improve regulations that, while unrelated to public safety, cause significant inconvenience in daily life. This includes the phased introduction of electronic pharmaceutical package inserts and allowing integrated management of quasi-drugs by pharmaceutical manufacturing managers, aiming to improve uniform regulatory standards by considering user characteristics. Additionally, from the development planning stage to pre-consultation, clinical trials, approval review, and response to global regulatory barriers, close support will be provided to enable rapid review and commercialization of innovative products through the establishment of the ‘Global Innovative Fast-track Review Support System (GIFT).’

The workshop was a great success with over 100 attendees, including CEOs of leading domestic pharmaceutical companies as well as representatives from digital therapeutics and bio companies. Won Hee-mok, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, said, "If the MFDS takes the lead in bold regulatory innovation and fostering the industrial ecosystem, this will also lead to strengthening the global competitiveness of the domestic pharmaceutical and bio industry," adding, "The industry will respond to the MFDS’s determination with continuous innovation and challenges."

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