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We will check with the Ministry of Food and Drug Safety about the future approval process for Corona 19 vaccines and treatments that are currently being developed in the country and abroad.
The Ministry of Food and Pharmaceutical Safety (Director Kang-lip Kim, hereinafter the Ministry of Food and Pharmaceutical Safety) has announced that a preliminary review is currently being carried out by the Ministry of Food and Pharmaceutical Safety of three vaccines developed by foreign pharmaceutical companies, and that a national developer of antibody treatment plans to apply for approval for its use within this month. .
First of all, if you look at the vaccine / treatment license review procedure, the drug approval process begins when a manufacturer or importer applies for an item license, and when applying for a license, the company provides the necessary data for the permission stipulated in articles 31 and 42 of the Pharmaceutical Affairs Law. It should be sent to ‘Safe Country’.
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 testing prior to administering drugs to humans, and clinical data is data that tests safety and efficacy by administering drugs to humans (patients ). These are data on the standards and test methods for the control of the manufacturing process and the quality control of the medicine.
The Ministry of Food and Drug Safety has organized and operated a dedicated COVID-19 vaccine / treatment approval review team, and final approval is granted by combining the results of the peer review 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 aims to shorten the existing processing period (180 days or more) and process it within 40 days through a preliminary review of each item and a rapid permit review by a team. dedicated permission review.
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Regarding the domestic shipment approval procedure, vaccines, which are biological products, can only be distributed and sold after passing the domestic shipment approval, which checks the quality once again by the state. This is a procedure to ensure the safety and efficacy of the vaccine once again.
National shipment approval must be applied by all national distribution companies, and the Ministry of Food and Drug Safety conducts and approves quality tests by serial number.In the case of Corona 19 vaccine, the treatment period existing (usually 2-3 months or more) is shortened and processed within 20 days. I plan to pursue it with the goal of doing so.
Regarding special manufacturing and import procedures, drugs can be manufactured or imported only after obtaining a product permit, but article 85-2 of the Pharmaceutical Affairs Law provides for special manufacturing and import procedures.
Heads of relevant ministries can request a special manufacturing or special import from the Ministry of Food and Drug Safety to adequately deal with the infectious disease pandemic, and they can manufacture or import pharmaceutical products that have not been approved for special manufacturing or special imports in Korea.
In the case of vaccines, several companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase 3 clinical trials.
On December 25, the Pfizer vaccine was approved for emergency use in eight countries, including the United States and the United Kingdom, and conditional approval in the European Union and Switzerland, and the Modena vaccine was approved for emergency use in the United States. Eight countries are the United Kingdom, Bahrain, Canada, Saudi Arabia, the United States, Mexico, Kuwait, and Singapore.
In Korea, five products are currently in clinical trials and most of them are in initial clinical trials (Phase 1, Phase 1/2).
Regarding treatment, Lily and Regeneron are conducting phase 3 clinical trials for antibody treatments and have been approved for emergency use in the United States.
Additionally, clinical trials are underway to add the efficacy and effect of COVID-19 treatment to existing drugs, such as ‘varicitinib’ (arthritis treatment).
In Korea, it was announced that a total of 15 products (13 ingredients), including antibody treatments, which are being developed as a new Corona 19 treatment, are undergoing clinical trials. Reporter Kang Kyung-nam
