39
Food and Drug Administration
Policy and Outcome
1. To Fortify the Drug’s Safety Monitoring System
(1) Adverse drug reactions (ADRs) reporting system
“
The National Adverse Drug Reactions (ADRs) Reporting System
”
was established
in 1998. In 2013, a total of 10,667 cases were reported to this system.
(2) Drug safety monitoring
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was announced in 2004,
and
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safety monitoring period
”
is required for new drugs. During the period of drug
safety monitoring, license holders shall voluntarily provide safety information on
drug used both domestically and abroad. From 2004 to the end of 2013, a total
of 284 new medicines are under new drug safety monitoring. On November 21
st
,
2013,
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drug risk management plan and the post-marketing clinical trials were also added
into the regulation.
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The ADR center and TFDA monitor domestic and international drug safety alerts,
for issue warnings to healthcare professional and the public. A total of 291 drug
safety alerts were received in 2013.
(4) Proactive monitoring of drug safety
The proactive monitoring of drug safety mechanism was established since 2010.
Such mechanisms actively analyze the post-market drug safety of high-risk drugs
by using national health insurance data as reference for drug safety re-evaluation
or planning of risk management.
2. Re-Evaluation of Drug Safety and Risk Management
For drugs with safety concerns, domestic and global data were collected to re-
evaluate drug safety. In 2013, there were 64 drugs re-evaluated, among them, 26
were required for risk management measures, including 22 safety labeling changes
or restricted use, 2 drugs were required to implement
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and 3 were off the market, including calcitonin nasal spray, meprobamate
and chloramphenicol oral dosage products.