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Food and Drug Administration


Participation of this taskforce will improve the international credibility of Taiwan's

generic drug

review system.

b. Since 2011, TFDA has been serving as the champion to lead the APEC 2020 Roadmap for Good

Review Practices on Medical Products for the APEC Regulatory Harmonization Steering Committee

(RHSC). From 2013 to 2014, TFDA was also part of the Good Review Practices Working Group.

APEC RHSC cooperated with the World Health Organization (WHO) to formulate and draft the

Good Review Practices Guidelines for Regulatory Authorities to improve international consensus

and efficiency of review practices. The draft was adopted by the WHO Expert Committee on

Specifications for Pharmaceutical Preparations in October 2014 and finalized by the WHO

Executive Board in May 2015.

c. TFDA also attended the 2014 annual meeting of the International Society of Addiction Medicine

held in the Japanese city of Yokohama from 1-7 October 2014 as well as the 142


Annual Meeting

and Exposition of the American Public Health Association held in the US city of New Orleans from

14-22 November 2014 in order to understand differences in the mode of abuse of prescription

medicine between the United States and Taiwan and to share systems used in Taiwan for

monitoring the flow of legal prescription medicine to illegal use.

d. TFDA is also participating in the activities of the Pharmaceutical Inspection Convention

and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the International Council for

Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the

Figure 9-1

The 6


IGDRP conference