[의학신문·일간보사=정민준 기자]The Ministry of Food and Drug Safety will shorten the deadline for approval for clinical trials from 30 days to 15 days for new substances and 7 days for already approved drugs.
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The Ministry of Food and Drug Safety (Director Kang-lip Kim) shared the preliminary status it has prepared to thoroughly and promptly carry out the approval and review of the Corona 19 vaccine and treatment drug currently being developed at home and abroad.
The Ministry of Food and Drug Safety has been running the’High-Intensity Rapid Productization Promotion Program (High GO-Quick Program)’ to support the development of vaccines and treatments since 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 to allow rapid entry into the clinical trial. .
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.
Currently, AstraZeneca and Janssen (Johnson & Johnson) are in charge of the virus vector vaccine team, and Pfizer and Modena, the antibody treatment team Celltrion, are in charge of the nucleic acid vaccine team.
In the case of vaccines, AstraZeneca (non-clinical October 6-, quality December 18-), Pfizer (non-clinical, clinical December 18-), Janssen (Johnson & Johnson) (non-clinical, quality) Quality was carried out on December 22nd -), and in the case of treatment, celltrion antibody therapy (non-clinical and quality, November 20th-) was used.
In order to further increase expertise and objectivity, the examination of the submitted materials such as non-clinical, clinical, and quality by the exclusive license examination team is conducted in an in-depth review (cooperative examination) method for each examination field.
In addition, the Ministry of Food and Drug Safety has formed and is operating a’Expert Council’ that consults external experts in order to increase the expertise and transparency of Corona 19 vaccine/treatment approval and review.
Thorough preparation for national shipment approval
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 large quantities 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.
An official from the Ministry of Food and Drug Safety said, “We aim to shorten the existing treatment period (180 days or more) through preliminary review, approval, and review for each item for Corona 19 vaccines and treatments, and to treat them within 40 days. “We will do our best to provide effective vaccines and treatments as quickly as possible.”