Building five major big data platforms and promoting regulatory reforms
R&D investment in biohealth will expand to over KRW 4 trillion.
Establishing an open innovation system for leading, startup, and venture companies

A 'national bio big data' of up to 1 million people will be built to be used for research and development of personalized new drugs and new medical technologies. Government R&D investment for the development of innovative new drugs and medical devices will increase to over 4 trillion won annually by 2025.

On the 22nd, the government announced the 'Biohealth Industry Innovation Strategy' in Osong, North Chungcheong Province.

The event was attended by approximately 300 people, including representatives from related ministries such as the Ministry of Health and Welfare, the Ministry of Strategy and Finance, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy, the governor of North Chungcheong Province, local members of the National Assembly, and local businesspeople.

The biohealth industry, including pharmaceuticals and medical devices, is a promising new industry with significant future growth potential and employment effects, and also contributes to national health.

Based on the potential of continuous private and government investment, world-class ICT infrastructure and medical and hospital systems, outstanding talent in the medical and pharmaceutical fields, and experience in the advanced semiconductor industry, early commercialization results are recently appearing.

The government plans to foster biohealth as one of the three next-generation key industries, along with non-memory semiconductors and future automobiles, to create leading global companies and foster an industrial ecosystem.

This innovation strategy, under the vision of "people-centered innovative growth" through the development of the biohealth industry, aims to revitalize the economy and create jobs through expanded exports, overcome rare and incurable diseases through the development of innovative new drugs, medical devices, and therapeutic technologies, and ensure the lives and health of the people.

To achieve this, the government is promoting innovation throughout the entire industrial cycle, from technology development to licensing, production, and market launch. Promote the creation of an ecosystem.


First, creating an innovative ecosystem for biohealth technology development.
The government recognizes that the global biohealth market is developing around personalized treatment technologies such as targeted anticancer drugs, and that data is the core foundation of such medical technology innovation. Accordingly, the government plans to establish five major big data platforms and utilize them as a national infrastructure to protect the lives and health of the people through the development of innovative new drugs and medical technology research.

First, a "national bio big data" will be established, encompassing up to one million individuals. Furthermore, "data-driven hospitals" will be designated to utilize the massive clinical trial data currently accumulated by each hospital for disease research, new drug development, and other purposes. To streamline the new drug development process, which is incredibly costly and time-consuming, a new drug development platform utilizing AI and other technologies will be established.

Additionally, we will foster hospitals as innovation hubs in the biohealth research ecosystem and expand government R&D investment for the development of innovative new drugs and medical devices. Accordingly, the government plans to expand its R&D investment in the biohealth sector, currently at around 2.6 trillion won per year, to over 4 trillion won by 2025.

Financial and tax support for the biohealth sector will also be strengthened.


Second, global regulatory rationalization.
The government recognizes that for the biohealth industry to actively expand overseas, our regulatory system must also align with international standards. Therefore, while protecting the lives and safety of the people, the government plans to boldly improve regulations that do not meet international standards.

First, we will shorten the approval period for pharmaceuticals and medical devices and advance the management system to suit the characteristics of regenerative medicine and biopharmaceuticals that utilize cells, genes, etc.

We plan to actively utilize regulatory sandboxes and regulatory-free zones to demonstrate innovative technologies and reflect the results in legal improvements. Furthermore, we plan to establish a regulatory improvement roadmap that matches the level of advanced economies in key sectors, such as pharmaceuticals and medical devices, in the second half of this year.


Third, supporting increased production vitality and shared growth.
The government will establish an open innovation cooperation system between leading companies and startups and venture companies. To this end, we support startups and venture companies by combining their promising technologies with the funding and global networks of leading companies, enabling them to jointly engage in overseas IR activities based on this foundation.

We will also cultivate pharmaceutical and biotechnology experts who meet the needs of industrial sites, such as AI-powered new drug development and biopharmaceutical production. Furthermore, we will reduce production costs by domestically producing raw materials and equipment necessary for biopharmaceutical production facilities, thereby fostering the shared growth of both upstream and downstream industries.


Fourth, support for market entry and promotion of overseas expansion.
Promote the use of new technologies, such as digital healthcare, in medical settings to improve the quality of face-to-face medical services and patient satisfaction.

By presenting patient monitoring guidelines permitted by current law, we will address market entry uncertainties for new digital healthcare services and support R&D to verify the effectiveness of innovative products.

With the enactment of the 'Medical Device Promotion Act' and the 'In Vitro Diagnostic Device Act' in April of this year and their implementation starting in May of next year, a comprehensive support system for innovative medical devices will also be established.

The government plans to smoothly implement this strategy, which was jointly developed by relevant ministries, by dividing it into tasks such as enactment and revision of laws, reflection in the budget, and improvement of systems.

The development of the biohealth industry is expected to lead to the development of innovative new drugs to overcome rare and incurable diseases, and to protect health sovereignty through the domestic production of pharmaceutical and medical device technologies, thereby strengthening national life and health security and driving "people-centered innovative growth" through economic growth and job creation.

Minister of Health and Welfare Park Neung-hoo said, “With the advancement of biohealth technology, we can effectively respond to the expanding medical demand in the aging society,” and added, “Korea has a world-class IT infrastructure and hospital infrastructure.”“With our stems, medical data, and talented individuals, we have the potential to leap forward as a global biohealth powerhouse,” he said.