[이코노믹리뷰=황진중 기자] The Ministry of Food and Drug Safety emphasized that a domestic antibody treatment development company plans to apply for approval in December.
On the 27th, the Ministry of Food and Drug Safety is conducting a preliminary review on three vaccine items developed by overseas pharmaceutical companies while explaining the future approval process for the Corona 19 vaccine and treatment drugs being developed at home and abroad. It has announced that it has announced that it will apply for approval for use.
According to the explanation, the drug approval process begins when a manufacturer or importer applies for an item license. When applying for a license, a company must submit the data necessary for the permission stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the’National Drug Safety Administration’. 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 studies before administering a drug to humans. Clinical data are data that test the safety and effectiveness by administering drugs to humans (patients). Quality data are data on the manufacturing process control, standards and test methods for quality control of the drug.
The Ministry of Food and Drug Safety has formed and is operating an exclusive review team for the approval of Corona 19 vaccine and treatment. For the data submitted by the company, the review results of experts in each field and the opinions of external experts such as the Central Pharmacy Review Committee are combined and approved for final approval.
The Ministry of Food and Drug Safety aims to shorten the processing period necessary for the existing 180 days or more through a preliminary review of each item and a prompt permit review by a dedicated permit review team to process it within 40 days.
Vaccines, which are biological products, can be sold and sold only after passing through the’national shipment approval’ that the state checks the quality once more. This is a procedure to ensure the safety and effectiveness of the vaccine once more. National shipment approval must be applied by all domestic distribution companies. The Ministry of Food and Drug Safety conducts and approves quality inspections by serial number.
The COVID-19 vaccine is planned to be processed within 20 days by shortening the treatment period, which is longer than the existing 2-3 months.
Pharmaceuticals can be manufactured or imported only after obtaining product permission, but Article 85-2 of the Pharmaceutical Affairs Act stipulates special manufacturing and import procedures. The heads of relevant ministries may request special manufacturing or special import from the head of the Ministry of Food and Drug Safety to appropriately cope with the pandemic of infectious diseases. If special manufacturing or special import is approved, pharmaceuticals that have not been approved for product can be manufactured or imported in Korea.
The COVID-19 vaccine is undergoing phase 3 clinical trials at a number of companies including AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson). On the 25th of this month, Pfizer vaccine was approved for emergency use in eight countries including the United States and the United Kingdom, conditionally licensed in the European Union and Switzerland, and Modena vaccine was approved for emergency use in the United States. In Korea, 5 products are currently undergoing clinical trials, and most of them are undergoing Phase 1 and Phase 1/2 clinical trials.
As for the treatment, Lily and Regeneron are undergoing phase 3 clinical trials for antibody treatments. Each of the two products was approved for emergency use in the United States. Clinical trials are in progress to add the efficacy and effect of COVID-19 treatment to existing drugs such as’varicitinib’ (arthritis treatment).
An official from the Ministry of Food and Drug Safety explained, “In Korea, clinical trials for a total of 15 products (13 ingredients), including antibody treatments being developed as a new Corona 19 treatment, are in progress.”