Page 52 - 2020Taiwan Food and Drug Administration Annual Report
P. 52
4FDUJPO c%FFQFO UIF /FX 4PVUI#PVOE &YDIBOHF JO
%SVH 3FHVMBUPSZ .BOBHFNFOU
Introduction of the Policy
Introduction of the Polic y
TFDA continues to cooperate and interact with the drug competent authorities of the
countries in New Southbound Policy in order to line with Taiwan’s New Southbound Policy
and globalization strategy; we also collect and study the drug management policies and
pharmaceutical industry information of ASEAN countries to understand the international
development trends. In addition, we also plan to promote the development of the Good
Laboratory Practice (GLP) certification and testing institutions for non-clinical drug trials
through interaction, cooperation and rapid development from Southeast Asian countries. By
doing so, we can strengthen the competitiveness of Taiwan’s products in the markets and
facilitate the global development of Taiwan’s biotechnology and pharmaceutical industry.
Implementation Strategy
Implementation Strate gy
I. Hosted the “2019 Taiwan-ASEAN Drug Regulatory Symposium”
TFDA hosted the “2019 Taiwan-ASEAN Drug Regulatory Symposium” from November
13 to 14, 2019 in order to strengthen the interaction with the pharmaceutical regulatory
authorities of ASEAN countries and assist the domestic pharmaceutical industry to understand
the latest pharmaceutical regulatory information on generic drugs. We invited representatives of
pharmaceutical regulatory authorities from Malaysia, Philippines, Thailand, and Japan to join
the meeting in Taiwan and the invited representatives shared the regulatory policies of generic
drugs in their countries. In addition, TFDA organized a face-to-face forum to help Taiwan's
pharmaceutical industry expand business opportunity and enter the markets in the south through
the two-way sharing, consultation, and interaction.
II. Promoted interaction regarding certification system of inspection
institutions
:H FROOHFWHG WKH LQIRUPDWLRQ RI WKH FHUWL¿FDWLRQ V\VWHP RI LQVSHFWLRQ LQVWLWXWLRQV IURP HLJKW
countries, including Cambodia, Sri Lanka, Bhutan, Brunei, Pakistan, Bangladesh, Nepal, and
Laos, to learn more about the inspection institutions of countries in the New Southbound Policy.
)URP -XO\ WR LQ ZH LQYLWHG RI¿FLDOV IURP 0DOD\VLDQ WR 7DLZDQ WR SDUWLFLSDWH LQ WKH
seminar of medical product GLP supervision institutions and observe the inspection of testing
institutions. By doing so, we share experience and exchange technology from both parties; from
September 15 to 21 in 2019, we invited officials from Australia, Vietnam, and Philippines to
Taiwan to give speeches for interaction (Figure 3-7); from October 20 to 26 in 2019, we sent
representatives to conduct interaction with the national surveillance agency in Australia.
50