Disease Control Cheong Establishes Procedures to Support Private Development of Vaccines and Therapeutics

Enactment of Notification to Promote Vaccine and Therapeutic Research and Development

The Korea Disease Control and Prevention Agency (KDCA) has established a legal framework to support the private sector's development of vaccines and therapeutics.

On the 26th, the KDCA announced that, based on the "Infectious Disease Prevention and Control Act," it will enact and implement a public notice regarding "Testing, analysis, and fees for infectious disease vaccine development" and "Testing, analysis, and fees for infectious disease therapeutic development" to revitalize domestic vaccine and therapeutic research and development. This legal framework supports testing and analysis, including efficacy evaluation, of infectious disease vaccine and therapeutic candidate substances developed by the private sector (industry, academia, research institutes, and hospitals). It signifies a strengthened national role and responsibility as the control tower for domestic vaccine and therapeutic research and development.

The public notice outlines detailed procedures for requesting testing and analysis of vaccine and therapeutic candidate substances, as well as support items for each testing and analysis category. The notice will take effect from the date of issuance, and detailed information can be found on the National Law Information Center and the KDCA website. Detailed guidance will be posted on the Public Vaccine Development Support Center website, and applications can be submitted through the Public Vaccine Integrated Information System. Detailed guidance on therapeutic testing and analysis will be posted on the KDCA website.

With the full implementation of the public notice, it is expected that accumulated technologies, experience, and facilities for vaccine and therapeutic evaluation and development support will meet the private sector's research and development demands.

Ji Young-mi, Commissioner of the KDCA, stated, "Through the enactment of this public notice, we hope that vaccine and therapeutic candidate substances developed by the private sector will become a stepping stone for national health safety, securing vaccine and therapeutic sovereignty, and localization. We will accelerate efforts to provide technologies that respond to field demands and the rapidly changing technological ecosystem."