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Food and Drug Administration


manufacturers regarding application for the Certificate of suitability to the monographs of the

European Pharmacopoeia (CEP). It is hoped that these activities will make Taiwan's pharmaceutical

industries more competitive, and build an environment that is beneficial for the general public, the

industry, and the government (Figure 9-3).

(2) According to

the Arrangement between Taiwan and Japan for


Framework of Cooperation on the

Medical Products Regulation

signed on 5 November 2013, Japan hosted the

2nd Joint Conference

of Taiwan and Japan on Medical Products

Regulation on 31 October and 1 November 2014 in Tokyo

(Figure 9-4). Open sessions and closed door meetings on the areas of pharmaceuticals, national health

insurance, and medical devices were convened to strengthen bilateral exchanges and regulatory

convergence between Taiwan and Japan. Cooperation details were also discussed. On the topic of

pharmaceutical products, both parties have established their respective working groups to cooperate on

five topics including new drugs and generic drugs review, management of OTC drugs, and cooperation

Figure 9-4

The Second Joint Conference of Taiwan and Japan on Medical Products Regulation

Figure 9-3

Hosting the joint symposium of TFDA and EDQM in Taipei