臺灣原料藥管理制度之發展進程

The Historical Development of the Management of Active Pharmaceutical Ingredients in Taiwan

為了維持藥品之安全及品質，國際間各國不論是在審查標準或GMP查核甚至後續查廠相關安全警訊的發布，皆不斷提升強化對藥品品質的管理，其中，原料藥的品質管控是重要的一環，我國在維護民眾用藥安全及精進國內製藥品質，持續追蹤並分析國內製劑之主成分來源採用狀況，並依其強化管理策略，如針對進口量最大的印度、中國大陸原料藥要求品質證明文件，至2016年推動製劑用原料藥全面符合藥品優良製造規範並登錄來源，使原料藥品質要求與國際標準一致，並於2017年度修訂藥品查驗登記審查準則，要求製劑查驗登記或變更原料藥來源應檢附原料藥技術性資料，並訂定技術性資料變更管理規範，使我國在管理不同來源之原料藥制度趨於統一，管理制度達到與國際接軌。 To maintain the safety and quality of medicines, countries in the globe have continuously improved and strengthened the management of quality control, including the review of post-marketing authorization and the inspection of manufacturer. Active pharmaceutical ingredients (APIs) also play critical roles in both domestic manufactured and imported medicine. To increase the management of APIs supplies and enhance relevant managing strategies, continuous tracking and analyzing of the sources are necessary. For instance, APIs imported from India and China was asked to provided quality certification documents, as these two countries are the top two imported sources. Since the year of 2016, it become mandatory for Taiwan APIs' manufactured and imported sources to comply with GMP and the source data should be registered electronically, which correspond with international standards. In 2017, the guidelines for the application of drug registration were revised to request for technical document in the process of registering and/or changing the sources of APIs, as well as to establish the standard of control for changes in technical document. The management of APIs from different sources has been unified, and the management system in Taiwan has reached the international standards.