Korea Plans Breakthrough System To Encourage Innovation
Following up on its May announcement of a conditional approval scheme to shorten R&D and approval periods, and aiming to ensure the prompt and stable supply of life-saving drugs, South Korea is planning a new law on breakthrough therapies and for drugs for public health crises.
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2016 has been full of shock and despair in South Korea’s political scene. But when it comes to the country’s biopharma policy, the year has seen fewer surprising or dramatic events.
After distributing safety letters on several cases of serious adverse skin reactions that occurred during the clinical development of Hanmi’s olmutinib, South Korean authorities have decided to limit the EGFR inhibitor to consenting patients and are closely monitoring its use.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.