Towards Global Harmonization: A Comparative Analysis of Taiwan's Pharmaceutical Track and Trace System
DOI:
https://doi.org/10.18060/28792Abstract
This article is a comparative study of the U.S. Drug Supply Chain Security
Act, the EU Falsified Medicines Directive, and Taiwan’s pharmaceutical track
and trace system. This comparative approach will highlight the commonalities
and differences in these various frameworks as they relate to pharmaceutical
track and trace and assess how these systems can learn from each other. The
article will provide a springboard for discussing an international framework for
pharmaceutical track and trace, focusing on legal and operational
interoperability. The core of the article will revolve around the need for national
pharmaceutical track and trace systems to be interoperable with other national
or regional systems. It will further emphasize how a collaborative international
approach is necessary to ensure the full effectiveness of the pharmaceutical
supply chain. This article will give special attention to Taiwan’s pharmaceutical
track and trace system, providing a description of Taiwan’s pharmaceutical
track and trace regime and the elements necessary for its success, its
weaknesses, and opportunities for growth in a global track and trace system. By
integrating the provisions of Taiwan’s Pharmaceutical Affairs Act, associated
regulations, and data from various sources, the Taiwanese government has
successfully created a comprehensive track and trace system for pharmaceutical
products. Integration among government systems in Taiwan further enhances
the track and trace ecosystem’s comprehensiveness, enabling data to undergo
various verification and auditing processes. Finally, this article will argue that
national track and trace systems should be interoperable with other national and
regional systems to guarantee complete protection of the pharmaceutical supply
chain. Therefore, this article will conclude with a proposal for a worldwide
unified, interoperable, and digital platform for pharmaceutical track and trace.
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