Page 61 - 2020Taiwan Food and Drug Administration Annual Report

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Introduction of the Polic
Introduction of the Policy
In order to expand the space and improve the condition of equipment and increase the new
production lines as well as R&D capacity in the factory under TFDA’s controlled. A new factory
has established according to the plan of “New Constructions and Renovations of Pharmaceutical
Manufacturing Facilities for Controlled Drugs,” by TFDA in July 2017; Furthermore it passed
the assessment from the PIC/S GMP on December 28, 2018, and resumed the production of
controlled drugs under Schedule 1 and Schedule 2 in 2019.

Implementation Strate gy
Implementation Strategy
The new factory is planned to expand the current production lines and capacity of the
production (Figure 4-2), to achieve the goal of self-production step by step enabling the

replacement of the current commissioned and imported products scope. The short-term target is
to increase and reach the self-produce for the injections from commissioned or imported scope;
the medium-term and long-term target are to add new production lines for solutions, capsules,
and patches to enough supply the Schedule 1 and Schedule 2 controlled drugs for all of the
medical institutions to provide more options for the drug use.

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