Page 92 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

report has been revised on Jan 13, 2016 to comply with the international standard.

D. Routine and for-cause inspections
Routine inspections are carried out at manufacturing sites of medicinal products.
Where a particular product is suspected of major quality issues, for-cause
inspections will carry out accordingly.

(2) Risk evaluation mechanisms and controls
A. Re-evaluation of medicinal product safety
New drugs pass monitoring period, death reports and medicinal products with
global safety alerts or other safety signals will be re-evaluated. The Medicinal

Product Safety Advisory Committee was established to help clarify the safety
concerns and suggest risk management measures such as issue a warning letter,
revision of package inserts, usage restrictions if necessary. In 2016, a total of 54
medicinal products were re-evaluated, of which risk management measures were
initiated for 20 medicinal products.
B. Medicinal product quality survey
(A) In response to quality defects reports of medicinal products, the companies

will be requested to submit investigation report and corrective and preventive
actions (CAPA) plans to TFDA according to GMP regulations and initiate
drug recall where necessary. In 2016, a total of 110 serious quality defects
were monitored, of which 8 medicinal products were recalled.
(B) For the medicinal product recall mechanism, companies shall be requested to
conduct a product recall according to the Regulations for Medicament Recall
and correct the quality nonconformance within a limited time in response to
the following: product defects reports require product recalls, where products
being recalled overseas have been imported, where post-market sampling

results failed to meet the specifications, where factory inspection identified
quality issues, or where companies have initiated product recalls voluntarily.
In 2016, a total of 301 medicinal products were recalled due to quality
problem.
C. Establishing the proactive drug safety monitoring mechanism
The Proactive Drug Safety Monitoring Mechanism was sequentially established
since 2010 by realizing the safety profile of medicinal products with important

potential risks in Taiwan using National Health Insurance Database in order
to provide a reference for drug safety re-evaluations and determining risk
management measures. Overall safety analysis projects were carried out for 11

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