The MFDS will enact a law covering special cases

Revealed in the National Assembly's report, will support as much as possible the commercialization of COVID-19 treatment and vaccine

The MFDS decided to promote the establishment of a law covering special cases to support the approval of vaccines and treatments for new infectious diseases such as COVID-19.

 

It also plans to establish the Central IRB to expedite clinical trials.

 

The MFDS made the announcement through the 'Major Business Reports' submitted to the National Assembly on the 15th.

 

The MFDS plans to focus on establishing an institutional foundation to support COVID-19 treatment and vaccine products.

 

First, it plans to promote a law covering special cases of the development and provision of public health crisis response products for rapid screening and approval of infectious diseases and vaccines, and support for development.

 

In addition, the establishment of the Central IRB for rapid and integrated deliberation of multi-center clinical trials is being promoted through amendments to the Pharmaceutical Affairs law.

 

In this regard, Seon-woo Kang , a member of Democratic Party of Korea had proposed a partial amendment to the Pharmaceutical Affairs law.

 

The Central IRB provides patient support, including consultation on the operation of the clinical trial committee for each institution and compensation for damages.

 

The MFDS has been operating a high-speed program since April, and has been promptly reviewing COVID-19 treatment and vaccines.

 

It provides research support for candidate substances, TF team, and overseas development status and review information.

 

As of June 30, 41 products received support such as consultation.

 

In addition, it is making efforts to rationalize the clinical trial review procedure for COVID-19 therapeutics and vaccines, and to expand the institutions conducting clinical trials.

 

In the past, the subject listened to the face-to-face description and signed a handwritten signature in order to consent to the clinical trial, but in the clinical trial of the COVID-19 treatment, the subject listened to non face-to-face explanation and improved the consent to be recorded or photo files.

 

The MFDS said, "We will stop the spread of COVID-19 and seek a quick solution to COVID-19 through the development of therapeutics and vaccines."