[한국방송/최동민기자] The approval review period for Corona 19 vaccine and treatment is expected to be reduced from 180 days to within 40 days. Global pharmaceutical companies AstraZeneca, Janssen, and Pfizer’s COVID-19 vaccine are currently undergoing preliminary review. On the 27th, the Ministry of Food and Drug Safety explained the approval process for a COVID-19 vaccine and treatment drug being developed at home and abroad, including these contents.
The drug approval process begins when a manufacturer or importer applies for product approval. Companies must submit non-clinical, clinical, and quality-related data to the Ministry of Food and Drug Safety’s Drug Safety Nara. Non-clinical data are data that verify the safety and effectiveness that have been verified through animal studies before administering drugs to humans.
Clinical data are data that test the safety and effectiveness by administering drugs to humans (patients), and quality data are data on standards and test methods for management of the manufacturing process and quality control of the drug.
For the data submitted by the company, the Ministry of Food and Drug Safety synthesizes and finalizes the review results of experts in each field and the opinions of external experts such as the Central Pharmacy Review Committee if necessary.
The Ministry of Food and Drug Safety has formed and is operating a dedicated COVID-19 vaccine/treatment approval review team, and aims to shorten the existing treatment period of 180 days through preliminary review and rapid screening for each item and process it within 40 days.
Vaccines, which are biological products, can be distributed and sold only after the national shipment approval, which confirms the product once more, and proves its safety and effectiveness. Corona 19 vaccine is planned to be processed within 20 days of the existing treatment period, which usually takes 2 to 3 months.
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 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.
The vaccine is undergoing phase 3 clinical trials at many companies around the world. As of the 25th of this month, 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, five products are currently in clinical trials, and most of them are in the initial phase, phase 1 or phase 1/2.
In the case of treatment, multinational pharmaceutical companies Lily and Regeneron are conducting phase 3 clinical trials for antibody treatments and obtained urgent approval for use in the United States. In addition, clinical trials are in progress to add the efficacy and effect of COVID-19 treatment to existing medicines such as’varicitinib’, an ingredient for treating arthritis.
In Korea, a total of 15 products (13 ingredients) are in clinical trials, including antibody treatments that are being developed as a new Corona 19 treatment. Inquiries: Ministry of Food and Drug Safety, Bio-Pharmaceutical Bureau, Biopharmaceutical Policy Division/ Food and Drug Administration Rapid Review Division 043-719-3316/5062