Page 7 - 2017食品藥物管理署年報(英文版)

To control the quality of medicinal products or medical devices on the market, TFDA
established the “Act governing medicinal products traceability system application and
management” in 2016 to request the pharmaceutical companies establishing a product source
and distribution management system. TFDA also primarily planned to include three categories

of medicinal products including blood preparations, vaccines and botulinum toxin (BTX) into
stage 1 advanced traceability scope.
It is worth mentioning that due to the amendments on related regulations and laws in
national cosmetics management, the registration of cosmetics has been replaced with products
registration, and the businesses have been asked to comply with the regulations for GMP, to
greatly align with international management trends.
The amount of online shopping had steeply increased in recent years. Among the sampled
inspections from hundreds of cosmetics purchased from online shopping platforms by TFDA
in 2016, the quality of those products all met the related requirements. However, 20% of the

package labeling still violated the regulations. In addition, TFDA also performed joint auditions
over high-violation, high-profiling and high-risk medical devices as well as cosmetics. Among

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