Page 46 - 2019食藥署年報(英文版)

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As of the end of 2018, a total of 206 batches of imported active pharmaceutical ingredients
were inspected in borders and no nonconformity was found. In addition, for the purpose
of strengthening the management of active pharmaceutical ingredients and inspection of
the conformity of the materials in the inventory, TFDA had inspected 334 items in 119
pharmaceutical factories by batches and no nonconformity was found.

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To strengthen the management of the pharmaceutical supply chain, TFDA established the trace and
track system of medicinal products in accordance with Article 6-1 of the Pharmaceutical Affairs Act, in

order to reduce the risk of counterfeit drugs entering the legal supply chain, and for drugs with doubts about
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Moreover, in order to cooperate with the digital management of drugs, we establish a drug
consultation database and information platform, to conveniently provide the general public with accurate
drug related information. In addition, we reinforce the active and passive monitoring mechanism of drugs,
to strengthen the risk control and ensure the safety of drugs for the citizens in Taiwan.

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blood preparations, vaccines and botox. Based on the risk assessment criteria in national
health insurance, on January 1, 2018 and July 1, 2018, we had announced and included
the high concern type 20 and 30 items in the trace or track management of medicinal

products in various phases.
(2) The trace and track system of medicinal products provides business operators with
diverse methods of declaration, for example data import, automatic upload, or login to
the web page and input data etc., and the operating interface of the declaration system
was improved in 2018 to simplify the declaration for business operators.
(3) In 2018, a new cross-reference and statistical analysis function was added, which is
able to provide statistics, inquiries, and output of reports. Furthermore, the authority is
given to the medicinal products license holders, to conduct query and cross reference

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