Page 131 - 2021 Taiwan Food and Drug Administration Annual Report

Table 11 Statistics of lot release procedures for biological drugs over the years

Vaccines and toxoids Blood preparations Antitoxin and antiserum Other
biopharmaceutical
The annual total
products
Year Domestic Imported Imported Domestic Imported Imported
Batches Doses Batches Doses Batches Doses
Batches Doses Batches Doses Batches Doses Batches Doses

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

2013 64 4,149,722 161 7,201,090 134 988,939 4 5,512 1 20 25 166,494 389 12,511,777

2014 72 3,705,462 155 7,607,454 121 962,552 6 8,440 0 0 27 332,558 381 12,616,466

2015 123 5,808,339 163 7,548,124 146 1,137,717 3 3,234 0 0 22 226,082 457 14,723,496

2016 58 4,122,437 152 6,773,750 146 1,363,462 9 6,078 2 19 29 422,944 396 12,688,690

2017 47 3,459,630 189 8,796,311 152 1,253,072 4 3,103 1 20 28 317,449 421 13,829,585

2018 69 4,923,435 202 8,509,618 145 1,175,986 3 2,976 1 15 33 214,220 453 14,826,250

2019 46 4,159,810 172 8,927,748 167 1,562,290 6 5,897 1 50 40 326,283 432 14,982,078

2020 52 4,736,457 181 10,203,078 163 1,609,298 6 2,629 0 0 46 259,651 448 16,811,113

Table 12 Statistics on the number of accredited laboratories and accredited items
over the years

Food accredited Drugs & Cosmetic / Drugs Cosmetic accredited Drug abuse accredited GLP accredited testing
laboratory accredited laboratory* laboratory* laboratory institution

Year Number of Number of
laboratories items
Number of Number of Number of Number of Number of Number of Number of Number of
laboratories items
laboratories items laboratories items laboratories items

2010 41 421 24 230 - - 13 9 9 19

2011 55 481 26 248 - - 13 9 16 26

2012 61 637 29 405 - - 13 9 18 42

2013 58 632 31 536 - - 13 9 20 58

2014 61 665 30 488 - - 14 9 17 49

2015 72 789 30 370 - - 15 9 15 53

2016 81 1,046 34 379 - - 14 9 15 44

2017 87 1,124 37 367 - - 14 9 14 55

2018 95 1,264 36 365 - - 16 9 13 56

2019 100 1,364 29 303 15 51 16 25 15 56

2020 92 1,376 29 319 16 51 18 32 15 16

*Note: The drugs & cosmetic accredited laboratory was divided into drugs accredited laboratory and
cosmetic accredited laboratory in response to the implementation of the “Cosmetic Hygiene and
Safety Act” on July 1, 2019.

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