Page 6 - 2017食品藥物管理署年報(英文版)

A healthy and beautiful life is closely related to the quality and safety of the food,

medicinal products, medical devices and cosmetics in our daily living, which are the greatest
responsibility of Taiwan Food and Drug Administration (TFDA). To help the public understand
the contents and progress of administration, TFDA complies and publishes the administrative
outcomes and associated statistics for the public’s reference.
For TFDA, 2016 was a challenging but prosperous year. In food management, TFDA
repeatedly amended food provisions and issued administrative rules over products that were
commonly used or bought or problematic previously. The key program included requesting

17 categories of food business to take their responsibilities of self-inspection. In addition, for
vendors that using toys to market meals, a significant labeling with alerts is required to help the
consumers understand food information.
For administration of food safety in circulating field, TFDA promoted the “Three-tier
quality control system”: The first tier focused on self-management by the business, which was
also the most important cornerstone of the system; the 2 tier included a 3 party certification
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body audit, including on-site inspection by verification institutes; and the 3 tier was the
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government inspection and test to complete a three-party monitoring system.

2017 Taiwan Food and Drug Administration

Annual Report: Foreword

By reviewing the outcomes of food source management of the year 2016, the public was
able to search for registration data as well as updated announcements regarding 420,000
businesses via the food businesses registration system, and government could effectively
control the conditions of the businesses.

In pharmacy administrative management, TFDA approved a total of 136 new medicinal
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products in 2016, which was the 2 highest record in the past 6 years. Some of those products
were for novel drug therapies or medicinal products containing new ingredients, including anti-
neoplasm, anti-HCV or quadrivalent flu vaccines, so the patients could have more treatment
options. More importantly, with the consultations and assistance of TFDA, a total of 19
domestic medical devices were approved for marketing, 12 devices entered into clinical trials
and 5 academic research technologies were successfully transferred to the industry by the end
of 2016, two of which were the first domestic “blood sugar monitoring system” collaborating
with smart phone and the marketing of the first global cervical cancer screening kit “carcinogen

methylation detection kit”.

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