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Food and Drug Administration
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Policies and Outcomes
1. Comprehensive Regulation
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advertisements for orally administered western medicine containing alcohol, regulations for registration
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products, clinical trial applications for human cellular therapy products, advertisements for solutions
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2. Registration of Medicinal Products
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preparations. Preparations can be further divided into new drugs, biological products, generic drugs
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and reports must be reviewed as well.
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growth rate of submission is 1.2 times more than 2013.
Genetic drugs 21,785
licenses, 81.64%
(19,531 domestic drug licenses;
2,254 imported drug licenses)
New drugs 1,771 licenses, 6.64%
(495 domestic drug licenses;
1,276 imported drug licenses)
(10 domestic drug licenses;
41 imported drug licenses)
Orphan drugs 51 licenses, 0.19%
(22 domestic drug licenses;
337 imported drug licenses)
Biological products 359 licenses, 1.35%
(602 domestic drug licenses;
2,115 imported drug licenses)
APIs 2,717 licenses, 10.18%
Figure 3-2
Statistics on pharmaceutical (2014)