118
2014 Annual Report
Annex table 9 Post market drug quality monitoring statistics
Year
Pharmaceuticals
Biologics
Chinese medicine*
Annual total
Cases Unqualified rate Cases Unqualified rate Cases Unqualified
rate
Cases Unqualified
rate
2004 562
0
340
0.59
800
-
1,702
0.22
2005 439
0.46
324
0
800
-
1,563
0.26
2006 484
3.31
137
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 83
3.61
108
4.63
629
4.70
820
4.41
2013 85
1.18
114
0
544
3.47
743
1.75
*
“
-
”
Background values for investigation
Unusual ingredients found in concentrated Chinese medicine formulation .In 2011 , two out of 64 of post market
product failed the qualification test.
unqualified rate (2*100/64=3.13%), in 2012 were 149,
unqualified cases were 7, unqualified rate (7*100/149=4.70%), in 2012 were 144, unqualified cases were 5, unqualified
rate (5*100/144=3.47%).
Annex table 10 Residue pesticides and veterinary drugs in food
Year
Monitoring of pesticide residues in agricultural products
from markets and packing firms
Determination of veterinary drug residues in foods
Case
no.
Conforming
cases
Non-conforming
cases
Conformity
rate(%)
Case
no.
Conforming
cases
Non-conforming
cases
Conformity
rate(%)
2004 1,276
1,268
8
99.4
-
-
-
-
2005 1,638
1,632
6
99.6
-
-
-
-
2006 1,605
1,589
16
99.0
-
-
-
-
2007 1,761
1,689
72
95.9
-
-
-
-
2008 1,765
1,557
208
88.2
-
-
-
-
2009 1,894
1,696
198
89.5
-
-
-
-
2010 2,051
1,856
195
90.5
330
324
6
98.2
2011 2,110
1,878
232
89.0
481
437
44
90.9
2012 2,363
2,121
242
89.8
572
532
40
93.0
2013 2,340
2,080
260
88.9
736
703
33
95.5
Annex table 11 Local health bureau auditing statistics
Year
Label inspection
Specimen testing
Food good hygiene practices (GHP) inspection
Label case
no.
Non-
confor-
ming no.
Confor-
mity rate
(%)
Testing
cases
Non-
confor-
ming no.
Confor-
mity rate
(%)
Inspec-tion
no.
Coun-
seling/
Deadline to
improve no.
Fined
cases
no.
Busi-
ness
cessa-
tion no.
No. of
cases
referred to
the courts
2008 795,119 16,188 97.96 43,545 2,629 93.96 143,779 34,177 65 81
6
2009 874,959 17,474 98.00 38,770 2,650 93.16 150,675 32,463 92 18
6
2010 796,758 15,140 98.10 38,056 2,493 93.45 136,456 28,967 131 5
3
2011 806,324 9,529 98.82 42,372 2,240 94.71 117,420 35,013 6 12
0
2012 683,956 7,027 98.97 41,956 1,958 95.33 118,681 49,587 75 13
0
2013 661,619 34,058 94.85 40,844 2,289 94.40 123,476 51,324 31 21
0