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2014 Annual Report
(3) On May, 22, 2013, TFDA made an announcement regarding to the adoption of PIC/S
GMP Guide for the active pharmaceutical ingredients manufacturers. Moreover, TFDA
had promoted the use of GMP raw materials and API DMF system. Fortifying the
management of product sources will safeguard the quality of medication.
Section 3 The Product Quality Chain Monitoring
Status
Many uncertain factors, such as drug manufacturing changes, transportation and storage
environmental impact, may affect the quality of drugs. So the drug good distribution
practice (GDP) is promoted to ensure the drugs in storage, transport and distribution
process, which quality and packaging integrity are still maintained. Establishing smooth
post-marketing quality chain includes the establishment of a reporting system, active
monitoring global drug product recalls and alerts, risk assessment mechanism to select
items, integration of the local health office resources, and implementation of drug quality
monitoring. In addition, cracking down illegal drugs and advertisement is one of important
projects.
Policy and Outcome
1. Quality Control and Monitoring of Medicinal Products
(1) Medicinal products quality defects reporting system
The reporting system of quality defects for medicinal products was established in 2004.
In 2013, a total of 831 quality defects were reported, including 144 high risk quality
defects reports, and 18 cases were recalled.
(2) Outcomes for the post market surveillance
In accordance with the health drug acts, random testing were conducted by the health
bureau under the concerns for the high risks factor to promote the quality control. In
2013, a total of 343 random testing were performed which including 6 violation and 56
nonviolent items. The violated items were sent back to the manufacturers under the
reinforcement of the local health bureaus (Table 3-3).
(3) Monitoring global drug product recalls and alerts
Foreign drug recalls information announced by other competent authorities are
monitored daily to prevent the recalled batches of the product from being distributed
in Taiwan. In year 2013, there were total of 702 recalls and alerts monitored, and 3
imported drug products were identified defective and voluntarily recalled by market
authorization holder.