Formation and operation of a dedicated permit review team, and approval for national shipment is also processed within 20 days
The Ministry of Food and Drug Safety has set a policy to significantly shorten the approval period for the Corona 19 vaccine and treatment currently being developed in Korea from 180 days to within 40 days.
On the 27th, the Food and Drug Administration announced plans for the future approval process related to the Corona 19 vaccine and treatment.
In the past, vaccines, which are biological products, can be distributed and sold only after passing the national shipment approval, which checks the quality once more.
However, in the case of Corona 19, the Ministry of Food and Drug Safety is planning to organize and operate a vaccine and treatment approval evaluation team, and to process the final approval through expert review results, etc. for rapid review within 40 days.
In the case of the Corona 19 vaccine, the existing national shipment approval processing period, which is usually 2 to 3 months or longer, will also be shortened, with the aim of processing within 20 days.
Pharmaceuticals can be manufactured or imported only after obtaining product approval, but Article 85-2 of the Pharmaceutical Affairs Act provides for special approval procedures.
The head of related ministries, such as the Korea Centers for Disease Control and Prevention, may request special manufacturing or import from the head of the Ministry of Food and Drug Safety to cope with infectious diseases. If this is approved, it is possible to manufacture or import pharmaceuticals that have not been approved for product in Korea.
There are five vaccines currently under development in Korea, and most are in the initial phase, phase 1 or phase 1/2 clinical stage.
In the case of treatment, a total of 15 products (13 ingredients) are in clinical trials.
The Ministry of Food and Drug Safety said, “A preliminary review by the Ministry of Food and Drug Safety is currently underway for three vaccines developed by overseas pharmaceutical companies, and domestic antibody treatment companies are planning to apply for approval for use within this month.”
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