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On the 27th, the Ministry of Food and Drug Safety is conducting a preliminary review of three vaccine articles developed by foreign pharmaceutical companies while explaining the future approval process for the Corona 19 vaccine and the treatment drugs that are being developed. at home and abroad. It has announced that it has announced that it will request permission to use.
According to the explanation, the drug approval process begins when a manufacturer or importer applies for an item license. When applying for a permit, a company must submit the data necessary for the permit prescribed in articles 31 and 42 of the Pharmaceutical Affairs Law to the ‘National Administration of Drug Safety’. The main data to be submitted are non-clinical, clinical and quality data.
Non-clinical data is data that verifies safety and efficacy through animal studies before a drug is administered to humans. Clinical data is data that tests the safety and efficacy when administering drugs to humans (patients). Quality data is data on the control of the manufacturing process, standards and test methods for quality control of the drug.
The Ministry of Food and Drug Safety has formed and is operating a dedicated review team for the approval of the Corona 19 vaccine and treatment. For the data presented by the company, the results of the expert review in each field and the External expert opinions, 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 required processing period by more than 180 days and process it within 40 days by preliminary review of each item and rapid approval review by a review team of Dedicated permissions.
The vaccines, which are biologics, can be sold and sold only after going through ‘national shipping approval’ which is quality checked by the state once again. This is a procedure to ensure the safety and efficacy of the vaccine once again. All domestic distribution companies must apply for domestic shipping approval. The Ministry of Food and Pharmaceutical Safety carries out and approves quality inspections by serial number.
The COVID-19 vaccine is scheduled to be processed in 20 days shortening the treatment period, which is more than 2-3 months.
Pharmaceutical products can be manufactured or imported only after obtaining the product permit, but Article 85-2 of the Pharmaceutical Affairs Law stipulates special manufacturing and import procedures. Heads of relevant ministries can request a special manufacture or special import from the head of the Ministry of Food and Drug Safety to adequately deal with the infectious disease pandemic. If special manufacturing or special import is approved, pharmaceutical products that have not been approved for the product can be manufactured or imported into Korea.
The COVID-19 vaccine is undergoing phase 3 clinical trials at several companies, including AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson). On the 25th of this month, the 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 the 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 phase 1 and phase 1/2 clinical trials.
Regarding treatment, Lily and Regeneron are in phase 3 clinical trials for antibody treatments. Each of the two products has been approved for emergency use in the United States. Clinical trials are underway 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 are underway for a total of 15 products (13 ingredients), including antibody treatments that are being developed as a new Corona 19 treatment.”
