MFDS Publishes COVID-19 Vaccine Development Guidelines

[Photo by the Ministry of Food and Drug Safety website] Ministry of Food and Drug Safety

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 16th that it has published guidelines to assist early entry into clinical trials of the novel coronavirus disease (COVID-19) vaccines and to support their commercialization.

The main contents include ▲ quality data requirements for investigational medicinal products ▲ considerations for non-clinical tests such as toxicity tests ▲ considerations for initial clinical trials ▲ considerations when setting evaluation items for safety, efficacy, and immunogenicity ▲ World Health Organization (WHO) COVID-19 vaccine guidelines (appendix), among others.

The Ministry of Food and Drug Safety is providing tailored consultations to 11 companies developing COVID-19 vaccines through the ‘K-Vaccine Rapid Review Task Force’ and is supporting them to swiftly enter the clinical trial phase.

The Ministry stated, "We will continue to actively support vaccine developers by providing new scientific information and domestic and international clinical trial information so that COVID-19 vaccines can be developed domestically as soon as possible."

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