Courtesy of AstraZeneca
The government has decided to reduce the approval review period from 180 days to 40 days in order to quickly introduce vaccines and treatments for novel coronavirus infections (COVID-19, Corona 19).
On the 27th, the Ministry of Food and Drug Safety unveiled a plan for approval of the Corona 19 vaccine and treatment containing these contents.
The Ministry of Food and Drug Safety is currently conducting a preliminary review of the vaccines of AstraZeneca, Janssen (Johnson & Johnson), and Pfizer, which are manufacturers of Corona 19 vaccines, which have signed a contract for introduction in Korea from next year. Celltrion, a domestic antibody treatment development company, said it plans to apply for use approval during this month.
According to the Ministry of Food and Drug Safety, the drug approval process begins when a manufacturer or importer applies for an item license. When applying for a license, a company must submit data on non-clinical, clinical, and quality necessary for the permission stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the Ministry of Food and Drug Safety.
The Ministry of Food and Drug Safety announced that it aims to reduce the processing period from 180 days to 40 days through a preliminary review of each item and a prompt review dedicated to permits.
Vaccines can be distributed and sold only after the national shipment approval, which checks the quality of the vaccine once more. The treatment period for national shipment approval is usually 2 to 3 months or longer, but in the case of the Corona 19 vaccine, the goal was to shorten it and process it within 20 days.
Drugs can be manufactured or imported only after obtaining product permission, 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 deal with infectious diseases. If this is approved, it is possible to manufacture or import pharmaceuticals that have not been approved for product in Korea.
The COVID-19 vaccine is being tested in phase 3 clinical trials at several pharmaceutical companies around the world. As of the 25th of this month, the Pfizer vaccine has been approved for emergency use in eight countries including the United States and the United Kingdom, and conditionally licensed in the European Union and Switzerland. Modena vaccine was approved for emergency use in the United States. In Korea, International Vaccine Research Institute, SK Bioscience, Celid, Genewon Life Science, and Genexine are currently conducting clinical trials, but most are in the initial phase, phase 1 or phase 1/2.
In the case of treatment, multinational pharmaceutical companies Lily and Regeneron are undergoing phase 3 clinical trials of antibody treatments, and they have received approval for emergency use in the United States. In the case of treatment, 15 companies, including Celltrion, which develop antibody treatments, are currently conducting clinical trials. Clinical trials are also being conducted to add the efficacy of COVID-19 treatment to existing drugs such as’varicitinib’, an ingredient for treating arthritis.