Page 49 - 2018食藥署年報(英文版)

Section 3 Management Policy on Medicinal Product

Trace and Track

Origin of Policy

To strengthen the management of medicinal products distribution, TFDA stipulated

the “Regulations governing the trace and track system for medicinal products” based on
Pharmaceutical Affairs Act Article 6.1, paragraph 3 on September 6, 2016. The regulations
specifically require vendors and manufacturers to establish a trace and track system based on
the quality, efficacy, safety and risk levels to connect the source and distribution of medicinal
products. The establishment of trace and track system is expedited in a faster manner due to the
counterfeit CRESTOR incident on March 2, 2017.

Implementation Measures

Starting on July 1, 2017, the Administration has prioritized three classes of drugs,
namely blood preparations, vaccines, and Botulinum toxins for Stage 1 trace and track system.
Throughout 2017, a total of 351 businesses were helped to complete their declaration process. For
the 116 items, the fulfillment rate of the declaration by the businesses exceeded 90%. In addition,
in order to maximize the categories and items available for traceability reports, the Administration,
on January 1, 2018 and July 1, 2018, respectively, based on the risk assessment and screening
principles of high use volume and high value of NHI-covered drugs and with items such as
orphan drugs, controlled drugs, and those with high technical thresholds and low counterfeiting

risk excluded, announced in phases inclusion of 20 and 30 items of high interest in the traceability
reporting system. Holders of permits for such drugs and distributors engaged in the wholesale of
such preparations shall upload information such as sources and whereabouts of drugs from the
previous month by the 10 day of the current month to the drug trace and track system.
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Outcomes and Benefits

The drug trace and track reporting system became operational in May 2017 and is user-

friendly with diversified interfaces; users can report by submitting Excel files (Comma Separated
Values, CSV files), Web API and by completing an online form. In addition, to boost the
familiarity of businesses and local health authorities with the drug trace and track system, the
Administration added the trace and track section on its website, created the page promoting the
exclusive zone for businesses in the reporting system, and set up the system consultation window.
Throughout 2017, a headcount of up to 1,700 people received consultations. In addition, the
Administration organized a total of 8 workshops and educational training sessions in 2017 for

businesses and public health centers, which were participated in by a headcount of 375 people in
total. The cooperation among businesses in reporting the required information and the reporting
efficiency was improved to consolidate the drug tracking or follow-up reporting system.

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