The government will improve related regulations so that pharmaceuticals utilizing new technologies can enter the market more quickly. The government announced the K-Bio pharmaceutical industry leap strategy prepared in cooperation with various ministries on 5th.
First, it will ease the requirements for phase 3 clinical trials of biosimilars (replica drugs of biopharmaceuticals). The plan is to introduce artificial intelligence (AI) to the approval review process and increase the review personnel, thereby shortening the review period by approximately four months.
The plan is to institutionalize the simultaneous progress of 'approval - benefit evaluation - drug price negotiation' by 2027, significantly reducing the health insurance registration period.
The government stated that it will promote a significant transformation in AI bio-pharmaceutical technology by supporting AI-based new drug development, AI and robot-based automated laboratories, and technology development in gene and cell therapy.
It will build a bio big data system covering 1 million Koreans and will also upgrade an integrated and shared platform. The government plans to train 110,000 key personnel in practical field applications and will expand the government fund necessary to stimulate the bio-pharmaceutical investment market across the entire new drug development cycle.
The government announced that it would provide full support in terms of infrastructure, finance, taxation, and personnel to secure a significant competitive edge in bio-manufacturing such as Contract Development and Manufacturing Organization (CDMO) and will increase the domestic production rate of materials, parts, and equipment.
It plans to support the growth of bio-venture core technologies to ensure they lead to the production of finished goods through open innovation.
The government stated that with the vision of 'K-Bio pharmaceuticals, a leap toward becoming one of the world's top five powers', it aims to double biopharmaceutical exports by 2030, create three blockbuster new drugs, and achieve a third-place ranking in clinical trials, thereby accelerating innovation.
On this day, the government held a bio-innovation forum at Songdo Convensia in Incheon, themed 'K-Bio, accelerating innovation,' to listen to the voices of about 130 representatives from related ministries, including the Ministry of Food and Drug Safety, the Ministry of Health and Welfare, the Ministry of Economy and Finance, the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, and the Ministry of Small and Medium Enterprises and Startups, as well as representatives from the domestic biopharmaceutical industry and various associations.
The free discussions were divided into two sessions, 'regulatory innovation' and 'growth and strengthening global competitiveness,' to allow effective discussions on the challenges faced by bio-pharmaceutical corporations.
President Lee Jae-myung said, 'I will swiftly implement the K-Bio pharmaceutical industry leap strategy by reflecting the opinions gathered through this forum and quickly improve related policies or regulations to resolve the challenges faced by corporations.' He also noted, 'I will gather the capabilities of both the public and private sectors to ensure that the bio-pharmaceutical industry can grow as a core growth driver for a sustainable future as a global leader.'