COVID-19, Oncology Dominate Korea’s Fast-Track Approval Program
New Breakthrough Therapy Scheme
Executive Summary
The number of approvals under a South Korean fast-track scheme launched around two years ago has increased, led more recently by COVID-19 vaccines and treatments, as well as anticancer drugs. Meanwhile, a new breakthrough therapy program similar to that in the US has been introduced to prioritize and speed up regulatory reviews of innovative medicines.
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