Advanced Regenerative Medicine and Advanced Biomedicine Safety and Support Act

Legislation no.: 
63
First published: 
27.08.2019
First EIF: 
28.08.2020
Latest published: 
10.12.2019
Legislation Status: 
In force
Latest notification: 
Notes: 

Previously notified in N2KOR41 and N3KOR13
Only in Korean
Items related to advanced bio-medicine and human cells

Imports may be carried out under the following condition: Those who import advanced bio-medicine and human cells must obtain permission from the Ministry of Food and Drug Safety (Regional Food and Drug Administration). And the importer can import them after completing the standard customs clearance report to the Korea Pharmaceutical Traders Association at each import.

The purpose of this Act is to contribute to the improvement of public health and quality of life by preparing a system for securing safety of advanced regenerative medicine and measures for innovation and practical use of technology, and by prescribing matters necessary for securing the quality, safety, effectiveness, and support for commercialization of advanced bio-medicine.
Those who import advanced bio-medicine and human cells must obtain permission from the Ministry of Food and Drug Safety (Regional Food and Drug Administration). And the importer can import them after completing the standard customs clearance report to the Korea Pharmaceutical Traders Association at each import.