2016 Review: Despite Political Woes, Korea Pro-Pharma Policies Stay Intact
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.
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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.
The South Korean government has unveiled a series of regulatory reforms that are designed to step up the competitiveness of the pharma industry and supply drugs in time for public health emergencies.
South Korea's Ministry of Food and Drug Safety has issued revised rules to ease the designation and approval of orphan drugs. The changes are expected to create an environment that would support aggressive development of orphan drugs by the domestic pharmaceutical industry and result in more treatment options for patients.