Korea Bolsters Stem Cell Rules, Allows Broader Gene Therapy
This article was originally published in PharmAsia News
Executive Summary
South Korea revised a set of rules in December to beef up its regulation of the stem cell and gene therapy sectors, which are seen as part of the country's new growth engines. Under the changes, the government will require stem cell therapy companies to submit risk management plans when they seek product approvals and will introduce a long-term tracking system. The scope of allowable gene therapy research will also be broadened following industry calls.
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