Designating Dedicated Personnel and Reducing Data... Government Rolls Up Sleeves for COVID-19 Treatment Development

[Asia Economy Reporter Choi Dae-yeol] The Ministry of Food and Drug Safety has decided to operate a high-intensity rapid productization promotion program from the 13th to develop treatments and vaccines for the novel coronavirus infection (COVID-19).

This support measure, called the Go and Rapid program, covers all stages of product development, from research and development to clinical approval and licensing review. In the initial research support stage, the government and affiliated research institutes will provide scientific advice when searching for candidate substances, and share COVID-19 virus infection animal models for developers to use in evaluating product efficacy.

A dedicated COVID-19 consultation window has been newly established within the Ministry of Food and Drug Safety. For items expected to have therapeutic effects, dedicated managers will be assigned to provide tailored support at each development stage. Vaccines developed using platforms with proven safety will be exempted from toxicity testing. The submission of data at each development stage will be minimized to facilitate entry into clinical trials. Additionally, a review team composed of experienced examiners will be formed to shorten the review period to within 7 days for substances with prior usage experience and within 15 days for new substances. Licensing will also be prioritized.

Furthermore, information including clinical trial design methods and considerations for COVID-19 treatment development will be provided, and the status of approvals for treatment and vaccine clinical trials will be promptly disclosed. Through international cooperation with organizations such as the International Coalition of Medicines Regulatory Authorities, clinical trial and review information conducted in various countries will be shared, and a hotline with the productization support team leader will be established to quickly resolve difficulties developers face during product development.

The Ministry of Food and Drug Safety stated, "We will pool our capabilities to rapidly develop safe and effective treatments and vaccines in cooperation with industry, academia, research institutes, and hospitals."

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