Page 15 - 111年衛生福利年報簡介及有聲書

品及相關產品標示查核及抽樣 檢驗52萬件，合格率達99%。 健全藥品管理法規環境，接軌 國際，落實藥品源頭管理、品 質與安全監測。強化管制藥品 流向管理及擴大列管品項;落 實新世代反毒策略，加強藥物 濫用防制宣導及進口原料藥查 驗，並提升檢驗量能。各年度 不法藥物查獲率已由99年之 11.81%大幅下降至110年之 1.69%。另，109年發布「上 市中藥監測辦法」，110年執 行監測抽驗結果，中藥材合 格率98.3%;中藥製劑合格率 99.1%。110年9月公告臺灣中 藥典第四版，以利中藥品質標 準與國際接軌，促進外銷。 推動醫療器材管理法於110年 5月1日正式施行，開啟醫療器 材管理新時代，成立智慧醫材 專案辦公室，促進產業發展; 施行化粧品產品登錄制度，接 軌國際，持續確保藥品與醫療 器材製造與運銷作業符合國際 PIC/S GMP及ISO13485標準。 因應管理各類產品需求，積極 開發檢驗方法，110年新增或修 訂檢驗方法達116篇;參與30 場國際共同研究或實驗室間能 力比對，獲國際肯定。 辦理風險管理及危機處理研討 會，透過跨單位交流提升數據 對策略擬定之量能;為防堵非 洲豬瘟疫區之豬肉製品走私進 口，我們持續以關鍵字監控電 商平臺產品。持續運用新興媒 體FB及TFDA LINE@，即時傳 播食藥醫粧知識及政策，提升 民眾正確知能。 examined with passing rate of 99%. Comprehensive Regulatory Environment for Medicinal product management, connect with the world, implement drug source management, quality and safety monitoring. The MOHW reinforced the flow management of controlled drugs and expanded the items being controlled. We implemented new generation anti-drug strategies, reinforced drug abuse prevention advocacy and import of active pharmaceutical material inspection, and upgraded the inspection capability. The annual seizure rate of Illegal drugs has dropped significantly from 11.81% in 2010 to 1.69% in 2021. In addition, we announced the "Regulations for the Post- Market Monitoring of Chinese Medicine". In 2021 monitoring inspection results, the qualification rate of Traditional Chinese medicine (TCM) materials was 98.3%, and the TCM preparation was 99.1%. In September 2021, we published the 4th edition of the Taiwan Herbal Pharmacopeia. The quality standard of our Chinese medicine can be connected with the world, benefitting exports. The Medical Device Act was enacted on May 1, 2021, marking a new era of medical device management. TFDA established the Intelligent Medical Device Project Office 7 to promote industrial development. The notification system was established for notifications of for cosmetic products to connect with the world and to ensure that the manufacturing and distribution practice of drugs and medical devices comply with the standards of international PIC/S GMP, and ISO 13485. In response to the management of all kinds of products, TFDA has been active to develop new test methods. In 2021, a total of 116 test methods have been added or amended. At the same time, TFDA has participated in 30 international joint research or interlaboratory comparisons with positive feedback from the international community. The MOHW conducted the risk management and crisis handling seminar. Through cross-sectoral exchange, we upgraded the efficiency of statistics for policy implementation. In order to prevent the smuggling of pork products from African swine fever-affected areas, we continue to monitor the products on the e-commerce platform with keywords. We continue to use new media such as Facebook fan page and TFDA LINE@ to spread pharmaceutical knowledge and policies timely, in order to disseminate accurate information for people. 2022 Taiwan Health and Welfare Report Introduction 13