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Fast program operation
The Ministry of Food and Drug Safety has been operating a ‘high intensity rapid production promotion program’ (also known as ‘GO-rapid program’) to support the development of vaccines and treatments since April last year after the corona pandemic 19. This is to promote the development of domestic vaccines and treatments, to scrutinize vaccines and treatments developed in foreign countries, and to quickly introduce them 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.
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GO-Fast program |
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✔ R&D support : Scientific advice and resource sharing in the development stage. ✔ Permit examination support : Waiver and expedited review of submitted data in case of expert consultation, approval of clinical trials and approval of products by reviewers with extensive experience in licensing and review. ✔ Support to share technical information : Provides information on clinical clearance and approval / exam status ✔ Support for international cooperation : Established a hotline to strengthen cooperation with foreign regulatory agencies and solve difficulties in product development. |
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In particular, in the case of approval of a 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 that the clinical trial can start as soon as possible. did. The deadline for approval of clinical trials was reduced from 30 days to 7 or 15 days.
Formation and operation of an exclusive permit review team.
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.
The purpose of this is to conduct a thorough review and approval by organizing a “ dedicated license review team ” comprised of expert reviewers in each field from 90 days before the product permit application is expected, and conduct a preliminary inquiry and review before applying for permission.
‣ Constitution and operation of a permit review team
-Virus vector vaccination team: AstraZeneca, Janssen (Johnson & Johnson)
-Nucleic acid vaccination team: Pfizer, Modena
-Antibody treatment equipment: Celltrion
‣ Preliminary review and start of review
-Vaccines: AstraZeneca (non-clinical 10.6 ～, quality 12.18 ～), Pfizer (non-clinical · clinical 12.18 ～), Janssen (Johnson & Johnson) (non-clinical · quality 12.22 ～)
-Treatment: treatment with Celltrion antibodies (non-clinical and quality, 11.20 ～)
In order to further increase experience and objectivity, the examination of the submitted materials, as non-clinical, clinical and quality, by the exclusive licensing examination team is carried out in an in-depth review method ( cooperative examination) for each examination field.
Corona 19 Vaccine / Treatment Expert Advice
The Ministry of Food and Drug Safety has also organized and operated a ‘Council of Experts’ that consults with external experts in order to increase the expertise and transparency of the Corona 19 vaccine and the approval and review of treatment.
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.
The Ministry of Food and Pharmaceutical Safety plans to consult with the Central Pharmacy Examination Committee, an advisory body to the Ministry of Food and Pharmaceutical Safety, as defined in the Law on Pharmaceutical Affairs.
①Reception → ② Preliminary examination → ③ Examination → ④ Consultation → ⑤Permission → Approval of national shipment (vaccine)
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Corona 19 Council of Vaccine and Treatment Specialists Meeting |
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Complaints and consultation agendas |
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Decision of the advisory committee and meeting schedule |
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Hold a counseling meeting and report the results |
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Opinion reflection |
Established a dedicated audit organization
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 Division is an organization dedicated to the rapid review for approval and review of Corona 19 vaccines and treatments, and is comprised of experts with an average of 10 years or more 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.
Preparation for domestic shipment approval
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 necessary to test and test mRNA vaccines using new technology will be established in advance before applying for permission. To this end, 9 types of testing equipment must be purchased urgently and a dedicated RNA testing room is secured in preparation for domestic shipment approval. I’m doing the best I can.
The Ministry of Food and Drug Safety aims to shorten the existing treatment period (180 days or more) through a preliminary review, approval and review by article for Corona 19 vaccines and treatments, and treat them within 40 days.
An official from the Rapid Review Division of the Korea Food and Drug Administration said: “We will do our best to ensure that vaccines and treatments are safely and effectively delivered as quickly as possible through thorough verification.”
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