Page 58 - 2018食藥署年報(英文版)

Section 8 Advancement of Testing Technology on Illegal
Drugs

Origin of Policy

The TFDA uses evidence-based method to uncover high-risk and high-violation rate
products, prevent illegal drugs from being distributed. The TFDA has also actively improved its
testing volume and capacity by participating in international meetings and experience exchange/

sharing.

Implementation Measures

1. Suspicious counterfeit drugs

As the counterfeit “CRESTOR” incident in March 2017 (Figure 3-7) severely compromised
safe drug use in Taiwan, the TFDA completed 79 CRESTOR sample testing within a week. Non-
conforming samples derived from lot MV503, MK479 and MF414 contained the counterfeit
substance Atorvastatin.
During sampling and testing, 28 samples derived from illegal factories and warehouses,
the TFDA also seized suspicious evidence of a counterfeit drug, including ingredients for
“Januvia,” Januvia tablets and packaging materials. For these reasons, the TFDA immediately

activated audition/inspection on a total of 462 commercialized products, i.e. 184 Januvia samples
(ingredient: sitagliptin), 150 VYTORIN samples (ingredient: Simvastatin/Ezetimibe), 117
LIVALO (ingredient: Pitavastatin), 11 ZYTHROCIN (ingredient: Azithromycin). After inspecting
the appearances, components and amounts, all of the above products met the manufacturer’s
specifications and thus all doubts have been cleared.
The TFDA responds very quickly to prevent counterfeit drugs from being distributed. A
total of 569 samples were tested in 2017. By adopting evidence-based science, the TFDA is able

Figure3-7 Samples of blood lipid lowering agent

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