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 commercialization. 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.
The statute also stipulates fast-track designation for eligible advanced biopharmaceuticals to give tailored and priority review from early stages of development.
Such designated medicines can be licensed upon safety and efficacy data from early-stage clinical trials under the condition of submitting future clinical data for more evidence. At this time, the deadline for processing the approval application is shortened from 115 days to 90 days.
In addition, a business entity must apply for a permit after being equipped with appropriate facilities, manpower and equipment in order to operate a cell processing facility or related management business that deals with cells, tissues, and organs derived from humans or animals.
But the law’s mandatory requirement of conducting a long-term follow-up of patients treated with already launched drugs is burdensome to local biopharmaceutical firms. The industry community also points out that it is over-regulation to require ministry approval when conducting a clinical trial with extracted samples based on hospital and patient consent.
By Kim Si-gyun and Minu Kim
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