MFDS Establishes Guidelines to Support Stable Supply of Vaccines and More...

The Ministry of Food and Drug Safety announced on the 8th that it has established the "Guidelines for Stable Supply of Vaccines, etc." which include administrative support procedures and methods to ensure the stable supply of vaccines and other biological products during infectious disease pandemics.

The guidelines contain measures for stable supply procedures, detailed administrative support information, and the establishment of a cooperative system among related agencies in the event of supply interruptions or shortages of biological products.

Vaccine stock photo. [Image source=Yonhap News]

Biological products, including vaccines, are approved for only a limited number of items and require national batch release approval from the Ministry of Food and Drug Safety. Due to their clinical characteristics that make alternative prescriptions difficult, any interruption or shortage in supply during infectious disease outbreaks inevitably has a negative impact on public health. Therefore, the Ministry has prepared these guidelines to provide rapid administrative support such as expedited review, expedited batch release approval, technical support for quality inspection, and emergency use authorization.

If a situation arises where vaccine supply is interrupted or insufficient, the Ministry will promptly carry out tasks in the order of collecting related information, investigation and analysis, preparing countermeasures, and implementing and evaluating those measures.

The Ministry of Food and Drug Safety stated, "We will continue to do our best to ensure that safe and effective pharmaceuticals are introduced in a timely manner and supplied quickly and stably based on regulatory science."

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