Page 94 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

to participate in discussions on promoting Good Review Practices (GRevP), Good Submission
Practice (GSP), and regulatory harmonization for pharmaceutical products in the Asia region,
making the ARC the perfect discussion platform for industry, government, academia, and
research institutions of countries around the world.

(3) Medical Devices
Taiwan is one of the founding members of the Asian Harmonization Working Party (AHWP).
Since 2012, a TFDA of?cial has served as the chairperson of the work group for the technical
committee of in vitro diagnostic devices (WG2 - Premarket: IVDD) and led the development
of five international IVDD guidance standards adopted as AHWP official documents. A TFDA
staff person has also become member of the professional committee of work group 3 of the
International Standard Organization / Technical Committee 212 (ISO/TC 212).
(4) Cosmetics
a. In September 2015, a TFDA delegation was sent to France and Belgium to visit the European
Commission Directorate-General Internal Market, Industry, Entrepreneurship and SMEs as well
as the French authority on cosmetics (Figures 2-8-1 and 2-8-2), and had exchanges on laws and
regulations governing cosmetic products and status of implementation for a number of speci?c
areas, such as product notification systems, product information files, GMP regulations for
cosmetics, and postmarketing management of cosmetics.

Visiting the European Commission Visiting the French authority on cosmetics (General
Figure 2-8-1 Directorate-General Internal Market, Figure 2-8-2 Directorate for Competition Policy, Consumer
Industry, Entrepreneurship and SMEs Affairs and Fraud Control, or DGCCRF)

2. Bilateral Activities (including signing of relevant agreements and memorandum of
understanding))
(1) The signing of the Joint Declaration of Cooperation for Drugs and Medical Devices by TFDA
Director General Yu-Mei Chiang and Prof. Dr. Karl Broich, President of The Federal Institute for
Drugs and Medical Devices (BfArM) of Germany, was witnessed by Representative Hwa-Yue
Chen, the Taipei Representative Of?ce in the Federal Republic of Germany (Figure 2-8-3). The
Joint Declaration of Cooperation was signed on October 13, 2015, allowing both signatories
to achieve further exchange of confidential documents and non-public information on
medicinal products, active pharmaceutical ingredients (APIs), and medical devices, improve
management proficiency of pharmaceutical affairs, and accelerate the market approval of
medical products in both countries, creating a mutually bene?cial environment.
(2) On November 5, 2013, the Arrangement between the Association of East Asian Relations
and the Interchange Associations for the Establishment of the Framework of the Cooperation
on the Medical Products Regulation was signed, where both parties agreed to take turns in
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hosting exchange meetings and conferences. Taiwan held the ?rst session of the meeting as