By the end of this year, all permits in the pharmaceutical field will be issued electronically, and the existing paper permits will be abolished by 2024.
The Ministry of Food and Drug Safety (MFDS) announced that it would expand the issuance of electronic permits to all pharmaceutical fields by the end of this year, in response to the need for easy access to real-time access without time and space restrictions instead of cumbersome paper permits.
To this end, from December 2020, the electronic permit issuance service was started from civil complaints regarding new drug product approval and notification, and from March last year, △Drug (quasi-drug) manufacturing (import) item permission/notification certificate △Drug (quasi-drug) manufacturing (import) It is issuing electronic licenses such as item change permission/notification certificate, drug item renewal certificate, (DMF) raw material drug registration certificate, and (DMF) raw material drug change registration certificate.
In addition, from October 2021, the subject of electronic license issuance has been expanded and implemented for △business license/report △quasi-drug product approval/report △clinical test-related approval and designation letter △GMP conformity assessment letter. It will be issued as a permit.
Specifically, the Ministry of Food and Drug Safety (MFDS) by the end of this year ▲Reporting/change of drug manufacturing (import) manager, safety management manager And it plans to take measures such as automatically reflecting the history of changes in business licenses.
The Ministry of Food and Drug Safety (MFDS) plans to abolish paper permits that have been in place since 1954 by the end of 2024 by expanding the subject of electronic permit issuance.
In this regard, the Ministry of Food and Drug Safety said, “Through the expansion of the introduction of electronic permits, the reliability and accuracy of drug approval information suitable for the knowledge-information and knowledge-information society can be secured, contributing to the improvement of services to the public, providing convenience in complaints, and providing paper permits from licensed companies such as pharmaceuticals. It is expected that the reliability and accuracy of drug approval information will be secured for the realization of smart administration by reducing costs by simplifying management tasks.”
By Kim Yong-joo, reporter kgfox11@kormedi.com
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