Page 15 - 112中文衛福年報簡介

2023 Taiwan Health and Welfare Report Introduction

查核 12 萬 717 家次，食品良好衛 inspection passed rate of over 90%. A total of 590,000 food and
related products were inspected and sampled, resulting in a pass
生規範準則合格率達 9 成以上；食
rate of 99%.
品及相關產品標示查核及抽樣檢驗
59 萬件，合格率達 99%。
We actively enhance the regulatory framework for Medicinal product
management, aligning it with international standards, to ensure
積極健全藥品管理法規，接軌國
the management of drug sources, quality, and safety monitoring,
際，落實藥品源頭管理、品質與
thereby safeguarding the public's drug safety. We reinforced the
安全監測，保障民眾用藥安全。
flow management of controlled drugs and expanded the items being
強化管制藥品流向管理及擴大列 controlled. We implement anti-drug strategies, and intensify efforts
管品項；落實反毒策略，加強藥 to prevent drug abuse, as well as enhance inspections of imported
物濫用防制宣導及進口原料藥查 active pharmaceutical ingredients (APIs), simultaneously, improving
our testing capabilities. The annual rate of illicit drug seizures has
驗，提升檢驗量能。各年度不法
significantly decreased from 11.81% in 2010 to 2.47% in 2022.
藥物查獲率已由 99 年之 11.81％
Furthermore, we have refined the regulations under the "Medical
大幅下降至 111 年之 2.47％。此
Devices Act" and "Cosmetic Hygiene and Safety Act," implemented
外， 精進「醫 療器 材 管理 法」及 diversified mechanisms to manage medical devices on the market,
「化粧品衛生安全管理法」各項規 strengthened regulatory consultations and guidance, and promoted
定，落實多元上市管理機制，強 industry development. We continue to ensure that the manufacturing
and distribution operations of drugs and medical devices comply
化法規諮詢輔導，促進產業發展；
with international standards such as PIC/S GMP and ISO 13485. We
持續確保藥品與醫療器材製造與
also promote compliance with the international ISO 22716 standard
運銷作業符合國際PIC/S GMP及
for cosmetic manufacturing facilities. Additionally, we have issued
ISO13485 標準；並推動化粧品製
the "Regulations for the Post-market Monitoring of Chinese Medicine
造場所符合國際ISO22716 標準。 Product," with 90% compliance rate for Chinese medicine materials
另發布「上市中藥監測辦法」， and 97% compliance rate for Chinese medicine preparations. In
September 2021, we announced the fourth edition of the Taiwan
111 年中藥材合格率 90%，中藥
Herbal Pharmacopeia, and the English version was published
製劑合格率 97%。110 年 9 月公
in 2022, enhancing the quality management of Chinese herbal
告臺灣中藥典第四版，於 111 年
medicines and aligning with international standards.
出版英文版，精進中藥品質管理
並與國際接軌。 In response to the management of various product needs, we have
actively developed testing methods. In 2022, we promulgated,
因應管理各類產品需求，積極開
amended, published or revised a total of 74 testing methods. We
發檢驗方法，111 年新增或修訂 also participated in 33 international collaborative research projects
檢驗方法達 74 篇，參與 33 場國 or laboratory proficiency testing programs, receiving international

際共同研究或實驗室間能力比對， recognition. Furthermore, we conducted risk management and
crisis handling seminars to strengthen our capacity for food and
獲國際肯定。亦辦理風險管理及
drug safety crisis management and emergency response. We
危機處理研討會，強化食品藥物
utilized emerging media platforms such as Facebook and the
安全危機處理之量能及緊急應變
TFDA LINE@ to disseminate timely information on food, drugs,
能力，運用新興媒體FB及TFDA
medical devices, and cosmetics, enhancing the public's knowledge
LINE@，即時傳播食藥醫粧知識及 and understanding of relevant policies and promoting accurate
政策，提升民眾正確知能。 awareness among the public.

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