[엠디데일리] The Ministry of Food and Drug Safety (Director Kang-Rip Kim) is preparing for the carbon-neutral era by reducing the issuance and use of paper documents such as permits, and to improve the convenience and efficiency of the application and processing of drug and quasi-drug licenses, the ‘Drug Safety Nara’ (nedrug.mfds.go) .kr) to improve the online system.
Major improvements include ▲Expanding the subject of issuance and management of electronic permits for pharmaceuticals and quasi-drugs, and establishing online application functions such as withdrawal of product licenses (October 29), and ▲Addition of virtual accounts to the payment method of license fees (November 5).
Expand the subject of electronic permit issuance and management to a total of 11 types. 9 types of licenses for manufacturing and importing pharmaceuticals and quasi-drugs will be added from the current 2 types of licenses for finished products and raw materials (implemented in March, ’21).
The added 9 types include pharmaceutical manufacturing/import business, quasi-drug manufacturing/importing business, quasi-drug items, clinical trial plan approval, clinical trial implementation institution designation, non-clinical test implementation institution designation, clinical trial education implementation institution designation, clinical trial sample analysis institution designation, GMP conformity certificate, etc.
In the case of initial approval, an electronic permit is issued without a separate application. In the case of a change permit application, the applicant scans the existing paper permit and submits it to the Drug Safety Nara first, and returns the original according to the instructions of the department in charge.
In addition, in the case of withdrawal of product license or application for closure of manufacturing/import business, the original paper license had to be returned by mail or visit, but in the future, it will be possible online as well.
In addition, the current license application fee could be paid by credit card payment or account transfer, but from November 5, the ‘virtual account’ method has been added, allowing payment without additional user authentication.
The Ministry of Food and Drug Safety announced that it will continue to improve so that applications such as drug and quasi-drug approvals can be processed more easily and conveniently in the Pharmaceutical Safety Nation.