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[엠디저널] The Ministry of Food and Drug Safety aims to shorten the treatment period of more than 180 days and treat it within 40 days through preliminary review, approval, and review by item for Corona 19 vaccines and treatments.Vaccines with safety and effectiveness through thorough verification He said he would do its best to ensure that the treatment was supplied as quickly as possible.
On the 2nd, the Ministry of Food and Drug Safety (Director Kang-rip Kim) reported on the status of preparations in advance to thoroughly and promptly carry out the approval and review of COVID-19 vaccines and treatments being developed at home and abroad. It was announced that it was shortened to within 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 productization, to support the development of vaccines and treatments from April last year following the corona 19 pandemic.
This is to promote the development of domestic vaccines and treatments, to thoroughly screen vaccines and treatments developed in foreign countries, and to quickly introduce them into the country. Research and development of candidate substances, clinical approval, permission review, technology information sharing, and international cooperation It is a program to provide differentiated support for 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 (drug re-creation), it is processed within 7 days so that the clinical trial can be quickly entered. did.
The Ministry of Food and Drug Safety has established a’team review operation system’ to thoroughly approve and review COVID-19 vaccines and treatments as clinical trials of vaccines and treatments are accelerated and applications for approval become visible.
From 90 days before the application for product permission is expected, the’Permission Deliberation Team’ composed of expert reviewers in each field has been formed, and prior consultation and review are conducted before application for permission, etc.
◆The licensing examination team consists of three teams ▶Viral vector vaccine team: AstraZeneca, Janssen (Johnson & Johnson) ▶ Nucleic acid vaccine team Pfizer, Modena ▶ Antibody treatment team Celltrion
◆The preliminary review is composed of two teams ▶The vaccine team consists of AstraZeneca (nonclinical 10.6~, quality 12.18~), Pfizer (nonclinical/clinical 12.18~), Janssen (Johnson & Johnson) (nonclinical/quality 12.22~) ～), ▶The treatment evaluation team is in charge of Celltrion antibody treatment (non-clinical and quality, 11.20～).
The examination of the submitted data, such as non-clinical, clinical, and quality, by the exclusive license examination team is conducted in an in-depth review (collaborative examination) method for each examination field to further enhance expertise and objectivity.
In addition, the Ministry of Food and Drug Safety has formed and is operating a’Expert Council’ that consults with external experts in order to increase the expertise and transparency of Corona 19 vaccine and treatment approval and review.
The expert council consists of experts in the field of quality, non-clinical, and clinical statistics, and clinical experts focusing on infectious medicine, and additional expert advice will be provided according to the consultation agenda.
In addition, it plans to consult with the Central Pharmacy Review Committee, an advisory body for the Ministry of Food and Drug Safety, as set out in the “Pharmaceutical Affairs Act” on the validity of the submitted data.
The Ministry of Food and Drug Safety established the’Expedited Review Division’ on August 31 of 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 consists of experts with an average of 10 years or more experience in non-clinical, clinical, and quality fields. It is a product that makes an innovative contribution to responding to public health crises or treating diseases such as infectious disease prevention or treatment, life-threatening disease treatment, etc.
The Ministry of Food and Drug Safety has organized a shipping approval task force for each type of vaccine for thorough national shipment approval of the Corona 19 vaccine, which must be supplied in a short period of time.
In particular, test methods necessary for testing and testing of mRNA vaccines using new technology will be established in advance prior to application for permission. For this purpose, 9 types of analysis equipment are urgently purchased and an analysis room dedicated for RNA is secured in preparation for national shipment approval. I am doing my best.
Reporter Lee Young-bok 48yblee
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