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TFDA launches track and trace system for medicinal products

【Update Date:2017-07-06unit:藥品組

Taiwan Food and Drug Administration (TFDA) announced that based on the Pharmaceutical Affairs Act, Plasma-derived medicinal products, Vaccine and Botulinum toxin are the first three priority categories required to comply with track and trace system, and it is effective from July 1st, 2017. The product license holders, wholesalers and retailers are required to submit the tracking and tracing information electronically before 10th of every month.

The degree of risk, and quality, efficacy and safety of medicines are taken into account to prioritize these three categories of medicines to be implemented with the prescription drug track and trace system.

In addition, due to the counterfeit Crestor event, TFDA has added twenty medicines with top national health insurance reimbursement items as a pilot category to implement the track and trace system. Several public meetings have been held by TFDA to illustrate the track and trace system. It is important to have face-to-face communications with the pharmaceutical companies to reduce difficulty of submission and to improve the willingness of declaration.

        The government is continuing to improve the functions of track and trace system with stakeholders. In the future, prescription drug track and trace system will be coordinated with the timetable of implementation of Good Distribution Practice (GDP) to expand the categories. The track and trace system is expected to reduce the possibility of counterfeit medicine distributed into supply chain, and to recall the products efficiently. It is also one of the policies to achieve TFDA’s goal and mission, to secure the public health for all.