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Comprised of experts with over 10 years of experience and a dedicated exam team for crown approval
Greater experience and objectivity through the in-depth review method
“Corona 19 vaccines and treatments will be processed within 40 days by shortening the existing treatment period (180 days or more) through preliminary review, approval and review by item.”
The Ministry of Food and Drug Safety announced on the 2nd about the preliminary status of preparations for the approval and examination of Corona 19 vaccines and treatments that are being developed in the country and abroad.
Since April 2019, the Ministry of Food and Drug Safety has been operating the ‘High Intensity Rapid Productization Promotion Program (GO-Rapid Program)’ to support the development of vaccines and treatments. It is a program that promotes the development of vaccines and domestic treatments and rapidly introduces vaccines and treatments developed abroad.
According to the Ministry of Food and Drug Safety, a ‘team review operating system’ was established as clinical trials for vaccines and corona treatments accelerated and the application for approval continued.
△ Virus Vector Vaccination Kit: AstraZeneca, Janssen (Johnson & Johnson) △ Nucleic Acid Vaccination Kit: Pfizer, Modena △ Antibody Treatment Kit: Celltrion, etc.
In order to further enhance experience and objectivity, examination of submitted materials, such as non-clinical, clinical, and quality, is done by in-depth review (cooperative review) for each examination field.
Furthermore, in order to increase the expertise and transparency of corona vaccine / treatment approval / review, the “Expert Council” is formed and operated to consult external experts.
The expert council consisted of experts in the field of clinical, non-clinical and quality statistics, and clinical experts focused on infectious medicine. For various drugs, he plans to consult with the Central Pharmacy Review Committee, an advisory body to the Ministry of Food and Drug Safety, as established in the ‘Pharmaceutical Affairs Law’, on the validity of the data presented.
The Ministry of Food and Drug Safety previously established the ‘Expedited Review Division’ on August 31, 2019 to proactively respond to the development of corona vaccines and treatments.
The expedited review department is made up of experts with an average of 10 years or more of experience in non-clinical, clinical and quality fields. Targets for a rapid review are products that make an innovative contribution to responding to public health crises or treating diseases, such as preventing or treating new infectious diseases and treating life-threatening diseases.
The Ministry of Food and Drug Safety has also organized a shipment approval team for each vaccine type for full approval of the national shipment of the corona vaccine. It is an organization prepared for a situation where a large quantity of goods must be supplied in a short period of time.
An official from the Ministry of Food and Drug Safety said: “Our goal is to shorten the existing treatment period (more than 180 days) by preliminary review, approval and review for each element of Corona 19 vaccines and treatments, and treat them within of the 40 days “. “We will do everything possible to provide effective vaccines and treatments as soon as possible.”
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