臺灣與紐西蘭、澳洲、新加坡藥品、醫療器材管理之研析   全文下載

Research and Analysis on the Management of Drugs and Medical Devices in Taiwan, New Zealand, Australia and Singapore

全球貿易自由化，發展區域經濟以強化國家競爭力，為必然之趨勢。後疫情時代，藥品與醫療器材之市場結構轉變，藉由我國醫療衛生實力及推動法規國際調和，有助我國醫藥產業全球佈局。本文就紐西蘭、澳洲、新加坡與我國之藥品、醫療器材管理制度，包括主管機關、法源依據、分類分級、製造業者品質查核系統、上市前與上市後管理等面向進行分析比較。整體而言，4者之藥品法規管理架構相似，且均為PIC/S之會員國，採用PIC/S GMP國際標準，均具上市前查驗及上市後不良反應通報與回收相關機制；醫療器材部分，4者分類分級各別參考美國、歐盟或GHTF之原則，而分為3或4個等級，另外，僅紐西蘭因尚未建立強制規定，而無需稽核製造廠，產品上市前無需取得核可，僅需於上市後登錄產品資訊。

Global trade liberalization and the development of regional economy to strengthen national competitiveness are inevitable trends. In the post-epidemic era, the market structure of medicines and medical devices has changed. The strength of Taiwan’s medical and health care and the promotion of international harmonization of laws and regulations will help the global layout of Taiwan’s pharmaceutical industry. This article analyzed and compared the management systems of drugs and medical devices among New Zealand, Australia, Singapore, and Taiwan, including the competent authorities, legal basis, classification, manufacturer’s quality inspection systems, and pre-marketing and post-marketing management. On the whole, the framework of drug regulations for these 4 countries are similar, and their competent authorities are all members of PIC/S who adopt the PIC/S GMP Guide. They also have premarket product registration as well as post-market surveillance and product recall systems. For medical devices, the classification and grading refer to the principles of the United States, the European Union or the GHTF, and are divided into 3 or 4 grades. In addition, it is not mandatory, only in New Zealand, to audit the manufacturing plant because the regulations has not yet established. Products information needs to be registered after appearing on the market.