"Establishing a 500 Billion KRW K-Bio Fund Within This Year... Focused Support for Securing Core Technologies"

Government Announces 'Bio Health Industry Innovation Plan'
Supporting Activation of Private Investment Worth 13 Trillion Won by 2026

The government will focus on supporting the development of infectious disease vaccines and therapeutics being pursued by biohealth companies. While strengthening the approval process, tax credits, and financial support for the biohealth industry, it plans to nurture it as a core industry that can secure future growth engines and high-quality jobs to lead national economic growth in an era of low growth.

On the 27th, the Ministry of Health and Welfare discussed the 'Biohealth Industry Innovation Plan' at the 4th Emergency Economic and Livelihood Meeting chaired by President Yoon Suk-yeol.

The government will first continue to support the development of COVID-19 vaccines currently in clinical trials by six domestic companies and therapeutics by 17 companies. It will assist the first domestically produced vaccine in passing the World Health Organization (WHO) prequalification and verifying the efficacy of additional doses to help its global expansion. Beyond COVID-19, it plans to research and develop vaccine candidates targeting infectious diseases with high pandemic potential such as MERS and Zika virus, secure core technologies, and support rapid vaccine development in times of crisis.

To activate private investment amounting to 13 trillion won by 2026, including companies like Samsung Biologics, Lotte Biologics, SK Bioscience, and Yu Biologics, cross-ministerial support will be established. The government will provide close support for approvals, locations, and infrastructure development, and swiftly strengthen tax credits, financial and policy fund support, and increase support limits through major related agencies. To promote investment in vaccines, the recently announced tax reform plan raised the corporate national strategic technology facility investment credit rate from 6% to 8%. Incentives for vaccine raw materials, equipment manufacturing technologies, and others will be increased, and investments from global companies such as Germany's Sartorius and the United States' Cytiva will be actively attracted.

In particular, to secure innovative new drug development and vaccine autonomy, a 500 billion won private joint 'K-Bio·Vaccine Fund' investing in pharmaceutical and bio companies will be established within this year and expanded to 1 trillion won in the future. Research and development funding totaling 2.2 trillion won, including 1.5 trillion won in government funds, will be provided by 2030 for new drug pipelines that have entered Phase 2 clinical trials after discovering effective substances.

From the perspective of regulatory innovation, innovative medical devices (non-invasive) such as AI and digital will be allowed for use as non-reimbursed or selectively reimbursed after approval. For innovative medical devices, the evaluation period required from approval to deployment in medical settings will be drastically shortened from the current 390 days to 80 days with minimal administrative procedures. The regulatory system will be completely redesigned to suit the characteristics of advanced products such as digital and advanced bio, providing close support until global market entry, and a biohealth-specialized regulatory sandbox reflecting the special nature of innovative technologies and services directly related to public life and health will be newly established.

Items urgently requiring domestic production will be prioritized for research and development support, and technology development and commercialization of bio small and medium-sized parts, materials, and equipment companies will also be pursued. Additionally, to supply the talent needed by bio companies and foster quality jobs, customized on-site workforce training will be promoted, and experts with industrial regulation knowledge and evaluation technology, such as master's and doctoral-level professionals in pharmaceuticals and medical devices, will be cultivated.

Furthermore, a foundation will be established to safely integrate and relay dispersed personal medical data for use as customized data, and the development of medical MyData services that can expand daily health management in medical care, caregiving, and health management and utilize platforms will be promoted.

Lee Ki-il, the 2nd Vice Minister of the Ministry of Health and Welfare, said, "We will promptly implement the biohealth regulatory innovation roadmap and field-oriented regulatory innovation, and actively resolve difficulties through continuous communication with the industry. We will also ensure that essential policies for strengthening private capabilities, such as the global mega fund and biohealth talent development plans, are carried out without delay."

This content was produced with the assistance of AI translation services.