The Ministry of Food and Drug Safety (MFDS) issued guidelines on Tuesday to help expedite Covid-19 vaccines’ entry into clinical trials and strengthen clinical trials' expertise.

Primary contents of the new guideline concern requirements for quality data of drugs for clinical trials, considerations in non-clinical trials such as toxicity test, considerations in initial clinical trials, considerations in setting criteria for safety, efficacy, and immunogenicity assessment, and the World Health Organization’s Covid-19 vaccine guidelines.

The ministry said it is providing customized counsels for 11 vaccine developers through its "K-Vaccine Rapid Review Team" to help their early entry into trials. The team is supporting 11 cases -- two approved trials and nine non-clinical studies in the development stage.

The ministry plans to continue to support vaccine developers with new scientific information and domestic and foreign clinical trial data so that they can develop Covid-19 vaccines as soon as possible.

For similar purposes, the ministry said that it had hired all 18 clinicians, the maximum quota allotted for 2020, to enhance the expertise in clinical trial review on drugs and medical devices, including those for Covid-19.

"The collaboration between pulmonologists and pediatrics played a major role in shortening review periods for clinical trial plans for Covid-19 treatments and vaccines from 30 to five days on average," the ministry said.