Page 128 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

Table 9. Statistics of drug permit licenses issued every year
Genetic drugs APIs NCEs Biological products Orphan drugs
Year Total
Domestically Domestically Domestically Domestically Domestically
Imports Subtotal Imports Subtotal Imports Subtotal Imports Subtotal Imports Subtotal
produced produced produced produced produced
2006 367 55 422 15 99 114 18 65 83 0 13 13 1 4 5 637
2007 422 32 454 6 115 121 22 47 69 0 16 16 0 0 0 660
2008 383 44 427 13 59 72 18 76 94 1 25 26 2 2 4 623
2009 449 47 496 5 91 96 24 56 80 0 17 17 0 2 2 691
2010 323 41 364 15 69 84 11 77 88 2 14 16 0 0 0 552
2011 220 52 272 20 172 192 17 46 63 1 24 25 0 2 2 554
2012 256 60 316 8 203 211 20 42 62 2 25 27 0 9 9 625
2013 247 51 298 7 105 112 23 14 37 0 1 1 0 3 3 451
2014 263 122 385 24 80 104 28 62 90 1 11 12 1 2 3 594
2015 175 86 264 18 81 99 27 90 117 0 35 35 3 5 8 520

Table 10. Statistics on post-market quality surveillance of medicinal products
Traditional Chinese
Medicinal Products Biopharmaceuticals Annual total
Medicine*
Year
Nonconforming Nonconforming Nonconforming
Items Items Items Items Nonconforming rate
rate rate rate
2006 621 2.58 0 0 860 - 1,481 2.58
2007 295 2.37 0 0 480 - 775 2.37
2008 164 16.46 0 0 1,000 - 1,164 16.46
2009 180 1.11 0 0 720 - 900 1.11
2010 198 3.03 0 0 660 - 858 3.03
2011 230 8.70 23 0 664 3.13 917 6.94
2012 168 4.76 23 0 629 4.70 820 4.41
2013 173 1.16 26 0 544 3.47 743 1.75
2014 90 3.33 148 0 134 2.99 372 1.88
2015 212 0.47 0 0 0 0 212 0.47
Note : "_" refers to a background value survey.

Table 11. Statistics of biological products lot releases
Other
Vaccines and toxoids Blood products Antivenoms and antisera
biopharmaceuticals Annual
Year
Domestically Imported Imported Domestically Imported Imported totals
produced produced
Batch Dose Batch Dose Batch Dose Batch Dose Batch Dose Batch Dose Batch Dose

2006 48 4,737,601 123 7,484,332 144 964,500 2 2,840 0 0 11 124,532 328 13,312,805
2007 67 6,134626 117 6,447,752 141 955,060 5 7,429 4 24 15 309,017 349 13,853,908
2008 47 4,209,083 159 9,001,470 130 1,019,543 2 2,926 3 27 14 232,549 355 14,465,598
2009 61 6,815,963 139 9,364,656 123 1,013,093 5 5,979 1 20 17 189,915 346 17,389,626
2010 46 5,870,554 115 6,881,397 116 894,973 4 5,923 2 31 18 281,084 301 13,933,962
2011 54 5,182,280 137 5,710,140 113 1,003,875 3 4,025 2 30 20 296,183 329 12,196,533

2012 53 4,509,491 146 6,711,965 115 960,004 3 4,348 1 20 22 498,230 340 12,684,058
2014 64 4,149,722 161 7,201,090 134 988,939 4 5,512 1 20 25 166,494 389 12,511,777
103 72 3,705,462 155 7,607,454 121 962,552 6 8,440 0 0 27 332,558 381 12,616,466
104 123 5,808,339 163 7,548,124 146 1,137,717 3 3,234 0 0 22 226,082 457 14,723,496

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