Page 93 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Chapter 8. International Cooperation and Cross-Strait

Exchanges
Exchanges and technical collaborations between different countries are becoming
increasingly important. International politics, economic, and trade would mutually in?uence each
other. One of the key strategies of the government's administration would be to gain an effective
understanding of global changes and align with international standards. Also through the Cross-
Strait Food Safety Agreement and Cross-Strait Agreement on Medical and Health Cooperation,
the TFDA upholds the spirit of creating a win-win environment for all related parties in order to
implement the noti?cation and exchange mechanisms by the agreements to promote collaboration
and development in the pharmaceutical and health industries.

Section 1. International Cooperation and Exchange Part II - Key Administrative Results International Cooperation and Cross-Strait Exchanges

Current Status
To improve the international visibility of Taiwan's food, drugs, medical devices, and cosmetic
industries, TFDA actively participates in international harmonization organizations, hosts
conferences on international regulations, and establishes platforms for bilateral partnerships.
Information on laws and regulations is compiled in order to revise local laws with the aim of
achieving global harmonization and aligning Taiwan's laws with international standards.

Policies and Outcomes

1. Participation in International Organizations and Events to Encourage Regulatory Harmonization
(1) Food
The TFDA attended the Asia-Pacific Economic Cooperation (APEC) Sub-Committee on
Standards and Conformance (SCSC) meeting as well as the corresponding Food Safety
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Cooperation Forum from August 23 to 26, 2015. The TFDA also attended the 1 Expert
Workshop on Harmonization of Pesticide Maximum Residue Limits (MRLs) for Imported
Foods in APEC Member Economies of SCSC to actively exchange food safety standards and
activities with other members from April 21 to 22, 2015.
(2) Medicinal Products
a. Since 2011, the TFDA has been serving as the champion of APEC 2020 Roadmap for Good
Review Practice on Medical Products in the APEC Regulatory Harmonization Steering Committee
(RHSC).The goal of the Roadmap was to improve the performance of health authorities and
promote regulatory convergence for medical products in the APEC region by 2020.
Since 2015, Taiwan has been promoting Good Submission Practices for applicants in the APEC
RHSC. Such activities were greatly supported by the Japan Pharmaceutical Manufacturers
Association (JPMA), and also promoted collaborations between competent authorities and
businesses of both countries. Participation of the APEC platform has promoted Taiwan's
regulatory exchange and regulatory convergence for medical products.
b. The TFDA also actively sought collaboration with the International Federation of Pharmaceutical
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Manufacturers & Associations (IFPMA), allowing Taiwan to host the 8 Asia Regulatory
Conference (ARC) from February 4 to 5, 2015, the very ?rst conference of its kind to be held in
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Taiwan. Taipei was selected as the venue for the 8 ARC, and representatives of national health
authorities governing pharmaceutical affairs as well as industrial experts from the US, EU, Japan,
Canada, South Korea, Singapore, Thailand, Malaysia, Australia, and Switzerland were invited
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