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On Day 2, the Ministry of Food and Drug Safety (Director Kang-rip Kim) reported on the status of preparations in advance to carry out comprehensive and expeditious approval and review of COVID-19 vaccines and treatments that are currently being developed at home and abroad, and the deadline for approval of clinical trials is from 30 days to 7 days or It was announced that it was reduced to 15 days to allow rapid entry into clinical trials.
The Ministry of Food and Drug Safety has been operating the ‘Go-Rapid Program’, a program to promote high intensity rapid production, to support the development of vaccines and treatments since April last year after the corona pandemic 19.
This is to promote the development of vaccines and domestic treatments, to scrutinize vaccines and treatments developed in foreign countries, and to introduce them quickly into the country. Research and development of candidate substances, clinical approval, review of permits, exchange of technological information and international cooperation It is a program to provide differentiated support to the back.
In particular, in the case of approval of the clinical trial plan, new substances are processed within 15 days, and if an approved drug or a drug in the clinical trial adds efficacy or effect (recreation of the drug), it is processed within 7 days so you can quickly enter the clinical trial. did.
The Ministry of Food and Drug Safety has established a ‘team review operating system’ to allow and scrutinize as Corona 19 vaccine and treatment clinical trials accelerate and approval requests become visible.
Since 90 days before the product permit application is expected, the ‘Permit Deliberation Team’ has been formed composed of expert reviewers in each field, and prior consultations and reviews are carried out before the permit application, etc.
◆ The license examination team consists of three teams ▶ Viral Vector Vaccination Team: AstraZeneca, Janssen (Johnson & Johnson) ▶ Pfizer Nucleic Acid Vaccine Kit, Modena ▶ Celltrion Antibody Treatment Kit
◆ The preliminary review is made up of two teams ▶ The vaccine team is AstraZeneca (non-clinical 10.6 ~, quality 12.18 ~), Pfizer (non-clinical / clinical 12.18 ~), Janssen (Johnson & Johnson) (non-clinical / quality 12.22 ~ ) ～), ▶ The treatment evaluation team is in charge of the Celltrion antibody treatment (non-clinical and quality, 11.20 ～).
Examination of submitted data, such as quality, clinical and non-clinical, by the dedicated licensing examination team is carried out in an in-depth review method (collaborative examination) for each examination field to further improve the experience and objectivity.
In addition, the Ministry of Food and Drug Safety has formed and is operating an ‘Expert Council’ that consults with external experts to increase the expertise and transparency of Corona 19 vaccine / treatment approval and review.
The expert council is made up of experts in the field of clinical, non-clinical and quality statistics, and clinical experts focusing on infectious medicine, and additional expert advice will be provided according to the consultation schedule.
In addition, he plans to consult with the Central Pharmacy Review Committee, an advisory body of the Ministry of Food and Drug Safety, as established in the “Law on Pharmaceutical Affairs” on the validity of the data presented.
The Ministry of Food and Drug Safety established the ‘Expedited Review Division’ on August 31 last year to proactively respond to the development of a vaccine and treatment for Corona 19.
The expedited review department is an organization that is in charge of expedited review for the approval and review of COVID-19 vaccines and treatments, and is made up of experts with an average of 10 years or more of experience in non-clinical, clinical fields and quality. It is a product that makes an innovative contribution to respond to public health crises or treat diseases such as the prevention or treatment of infectious diseases, the treatment of life-threatening diseases, etc.
The Ministry of Food and Pharmaceutical Safety has organized a shipment approval working group for each type of vaccine for the full approval of the national shipment of the Corona 19 vaccine, which must be supplied in a short period of time.
In particular, the test methods required to test and analyze mRNA vaccines using new technology will be established in advance prior to application for authorization. To do this, 9 types of testing equipment are urgently purchased and a dedicated RNA testing room secured in preparation for domestic shipment approval. I’m doing the best I can.
Reporter Lee Young-bok 48yblee
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