[대한뉴스=정미숙 기자] The Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) has established the “Regulations on the Renewal of Business Permits for Human Cells, etc. and Advanced Biopharmaceuticals” (Food and Drug Notice) was enacted and enforced on August 14.
ⓒ Daehan News
The business license (report) renewal system is to closely manage the quality and safety of cells and tissues by regularly inspecting and managing the head of cell processing facilities, human cell management companies, and high-tech biopharmaceutical manufacturers, importers, and consignment manufacturers and sellers. It is a system to renew the hazard permit (report) certificate every three years.
The notice enacted this time stipulates the renewal application procedure, the scope of documents to be submitted, and the procedure for supplementing data necessary for the operation of the business permit (report) renewal system. The main contents are as follows.
(Application deadline) 120 days before the end of the validity period of the license for the head of a cell processing facility and manager of human cells, etc., and 60 days before the end of the expiration date for the license (report) certificate for advanced biopharmaceutical manufacturing/importing/consignment manufacturing and sales business operators Should be.
(Documents to be submitted) When applying for renewal, the original permit (report) certificate and data proving that the renewal standards are met must be submitted.
(Calculating the period of validity) After renewal of the permit (report) certificate, the period of validity is extended to 3 years from the date of expiration of the existing period of validity.
(Renewal Criteria) ❶Facilities, personnel, and equipment standards, ❷Work performance, and ❸Compliance with the 「Advanced Renewable Bio Act」 and the 「Pharmaceutical Affairs Act」 should be checked.
(Data supplementation procedure) If data supplementation is necessary, supplementation can be requested within 40 days (20 days for manufacturing/import/consignment manufacturing and sales business) from the date of application for renewal.
The Ministry of Food and Drug Safety expects that the enactment of this notice will help secure the quality of advanced biopharmaceuticals and human cells and provide safe medicines to patients. I will try my best to make it happen.
For details, visit the website of the Ministry of Food and Drug Safety (mfds.go.kr) → Laws and data → Law information → Notifications, directives, established rules, or the National Law Information Center of the Ministry of Government Legislation (law.go.kr).
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2023-08-14 10:58:00
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