8 September 2020 - Korean health regulators will shorten licensing review period from 115 days to 90 days for investigational bio drugs to treat severe or rare disease or pandemic disease with no available alternative, according to a subordinate statute under the Advanced Regenerative Medicine Act.

The statute released by the Ministry of Food and Drug Safety on Monday is designed to strengthen the quality and safety management of biopharmaceuticals and to support rapid commercialisation. 

Under the new legislation, local biopharmaceutical developers should report an investigation plan to the ministry within 15 days and come up with a response plan within 6 months when there is a serious adverse event in the use of advanced biopharmaceuticals such as cell or gene therapy products that use human cells.

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