Page 48 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

apply for medicament manufacturing licenses ( GMP/QSD registration letters), or

apply for changes to their medical device manufacturing licenses by switching to other
manufacturers that have already acquired medicament manufacturing licenses before
they can continue the production or import of relevant products.

4. Cosmetics source management
Since 2008, TFDA and the Industrial Development Bureau (IDB) of the Ministry
of Economic Affairs (MOEA) jointly promoted voluntary GMP validation mechanisms

for cosmetic factories to improve manufacturing quality of the products. Cosmetics
manufacturers are currently required to submit documented information to IDB and IDB
then assembles an audit team to perform the audit. Manufacturers that pass the audit
may then apply for a GMP certificate from TFDA. At the end of 2016, a total of 146
cosmetic manufacturers have voluntarily applied for GMP audits with IDB, of which
102 successfully passed the audit. In 2016 alone, 23 manufacturers applied and 16
successfully passed, for a qualification rate of 69.6% (Figure 3-6).

Cases Percentage
30 100
86.7
83.3 90
25
24 70.6 75.0 80
23
70
20 20 20 69.6
55.6 54.5 56.3 60
45.5 16 17 16
15 15 15 50
13
12 40
11 11
10
9 9 30

6 20
5 5 5
10

0 0
97 98 99 100 101 102 103 104 105
Year
Factories applied Factories met
for GMP GMP Pass rate (%)

Figure 3-6 List of manufacturers that applied for and passed cosmetics GMP from 2008 to 2016

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