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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

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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947

and 3 were off the market, including calcitonin nasal spray, meprobamate

and chloramphenicol oral dosage products.