Authorization rate for No.16 is still 0%
By Lee, Hye-Kyung | translator Kim, Jung-Ju
23.09.17 08:38:40
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The Ministry of Food and Drug Safety recently designated 'BI 1015550' as a substance, starting with 'Run Sumio' in November last year
New 'GIFT' system for rapid screening of global innovative products in September last year
While the Ministry of Food and Drug Safety recently completed the designation of 'Global Innovative Product Rapid Review (GIFT)' No. 16, there are still no items that have been approved using this system. The Ministry of Food and Drug Safety established the Global Innovative Products on Fast Track in September last year. It also contains innovative, gifted medicines that can pioneer new areas of treatment.
The most recently designated GIFT item is the 'BI 1015550' substance, a treatment for idiopathic pulmonary fibrosis. The product name has not been confirmed. The drug has been designated as a GIFT for improved effectiveness, and is currently being approved by the U.S. FDA in BTD process. In Korea, it wa
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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