Page 128 - 2021 Taiwan Food and Drug Administration Annual Report

Table 5 Statistics of approved drug licenses over the years

Generic drugs Active pharmaceutical New drug Biologicals Rare medicine
ingredients Domestic Imported Domestic Imported Domestic Imported Sum

Year Total

Domestic Imported Sub- Domestic Imported Sub- Sub- Sub-
total total total total

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 11 0 3 3 451

2014 263 122 385 24 80 104 28 62 90 1 11 12 1 2 3 594

2015 175 86 261 18 81 99 27 90 117 0 35 35 3 5 8 520

2016 202 84 286 48 191 239 12 141 153 0 16 16 1 3 4 698

2017 196 90 286 28 193 221 20 120 140 1 15 16 2 16 18 681

2018 154 48 202 8 166 174 34 97 131 1 29 30 0 12 12 549

2019 171 50 221 4 147 151 36 63 99 0 23 23 2 3 5 499

2020 164 45 209 3 170 173 21 69 90 2 27 29 0 10 10 511

Table 6 Number of valid GMP/QSD registration letters for medical equipment
over the years

Year Valid GMP registration letters Valid QSD registration letters

2010 236 1,340

2011 486 2,777

2012 531 3,065

2013 568 3,213

2014 565 3,057

2015 685 3,640

2016 669 3,800

2017 704 3,925

2018 748 4,177

2019 792 4,338

2020 878 4,720

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