The Ministry of Food and Drug Safety announced that it aims to process within 60 days from the screening of the novel coronavirus infection (Corona 19) vaccine to the national shipment approval procedure.
The Ministry of Food and Drug Safety announced on the 27th, explaining the future approval process for the Corona 19 vaccine and treatment drug being developed at home and abroad.
The Ministry of Food and Drug Safety recently announced that it is undergoing a preliminary review of three vaccines developed by overseas pharmaceutical companies, and that a domestic antibody treatment development company is planning to apply for approval within this month as a treatment.
The drug approval process begins when a manufacturer or importer applies for an item license, and at this time, the company must submit the data necessary for the approval stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the’National Drug Safety Administration’ of the Ministry of Food and Drug Safety.
The main data to be submitted are non-clinical, clinical, and quality data. ▲ Non-clinical data are data that verify safety and effectiveness through animal tests before administering drugs to humans. ▲ Clinical data are administered to humans (patients). It refers to data that has been tested for safety and effectiveness. Also ▲Quality data are data on the manufacturing process management, standards and test methods for quality control of the drug.
Currently, the Ministry of Food and Drug Safety has formed and is operating an exclusive COVID-19 vaccine/treatment license review team to review the submitted data, and the data submitted by the company are reviewed by experts in each field and, if necessary, consulted opinions from external experts such as the Central Pharmacy Review Committee. The final permission is given by synthesizing.
Generally, the drug approval process takes more than 180 days, but the Ministry of Food and Drug Safety said, “We aim to shorten the existing processing period and process it within 40 days through the preliminary review of each item and the rapid approval review of the exclusive approval team.” .
In addition, vaccines, which are biological products, can be distributed and sold only after passing the national shipment approval, which checks the quality once more by the state.
The national shipment approval is a procedure to ensure the safety and effectiveness of the vaccine once more, and must be applied by all domestic distributors, and the Ministry of Food and Drug Safety conducts and approves the requested item by conducting a quality inspection by serial number.
The national shipment approval procedure usually takes 2-3 months or more, but the Ministry of Food and Drug Safety said, “In the case of the Corona 19 vaccine, we plan to shorten the existing treatment period and treat it within 20 days.”
In addition to the above formal approval procedure, the Ministry of Food and Drug Safety also suggested a plan to manufacture or import unlicensed drugs in Korea in the context of a conflict.
The Ministry of Food and Drug Safety said, “In general, pharmaceuticals can be manufactured or imported only after obtaining an item permission from the Ministry of Food and Drug Safety, but Article 85-2 of the Pharmaceutical Affairs Act regulates the’special manufacturing/import’ procedure, so that “You can request import,” he said. “If you get approval for special manufacturing or import, you can manufacture or import pharmaceuticals that have not been approved for product in Korea.”
On the other hand, looking at the development status of vaccines and treatments for COVID-19 in Korea and abroad that the Ministry of Food and Drug Safety has released, a number of companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase 3 clinical trials for vaccines.
As of the 25th, the Pfizer vaccine was approved for emergency use in eight countries (UK, Bahrain, Canada, Saudi Arabia, the United States, Mexico, Kuwait and Singapore) including the United States, and conditionally licensed in the European Union and Switzerland. The Modena vaccine has been approved for emergency use in the United States.
The Ministry of Food and Drug Safety said, “In Korea, five vaccine products are currently undergoing clinical trials, and most of them are undergoing initial clinical trials (Phase 1 and Phase 1/2).” Clinical trials of a total of 15 products (13 components) including antibody treatments in progress are in progress,” he said.