2020-2021年輸入藥品許可證新增或變更原料藥製造廠案件分析   全文下載

Survey on the Applications for Addition or Change of the Source of Active Pharmaceutical Ingredients of the Imported Drug Products in 2020 and 2021

COVID-19疫情以來，由於全球原料藥最大來源國中國及印度陸續執行封城或限制藥物出口等政策，引起全球藥品供應鏈對於藥品短缺之恐慌。本報告分析2020-2021年輸入藥品許可證新增或變更原料藥製造廠申請案件共237件，其中原核准原料藥製造廠在中國及印度者分別占申請案13%及14%，新增或變更之原料藥製造廠所在國以中國（40%）為最多，其次為印度（8%），由此可知，2020-2021年期間，我國輸入藥品變更後原料藥來源仍以中國及印度為主要來源國，並未受國外疫情影響。有關藥品查驗登記審查準則第49-1條第2項第6款規定，應檢附「依劑型特性之製劑成品檢驗結果比對評估資料」之要求，本報告分析結果顯示，各廠商所檢附之技術文件資料並不一致，以檢附變更前後成品檢驗成績書及評估報告者占最多數（63%），申請時檢附變更前後成品溶離率比對資料者佔13%，未來或可考慮酌修相關法規，使申請者於檢送相關資料能有更明確依據。

China and India, the global main sources of active pharmaceutical ingredients (API), announced policies that enacted a lockdown or restricted medicine exports due to the outbreak of the COVID-19 pandemic, which caused a panic caused by the drug shortage in the global drug supply chain. This study investigated a total of 237 applications for the addition or change of the sources of API of imported drug products in Taiwan from 2020 to 2021. The result showed that the current API manufacturers out of 13% and 14% of the applications are located in China and India, respectively. Moreover, the site of the highest number of cases involving the addition or change of the source of API is China (40%), followed by the second-highest ones from India (8%). Consequently, China and India are the main countries for the applications of the addition or change of the API sources of imported drug products in Taiwan in the 2020 to 2021, regardless of COVID pandemic. Besides, the required documents, concerning “comparison and evaluation of the finished preparations according to the characteristics of the dosage forms”, according to the regulations in the article 49-1 of Regulations for Registration of Medicinal Products, provided by applicants were not consistent while 63%, the highest proportion, applicants provided the certificates of analysis with currently approved and proposed API manufacturers and 13% applications provided a dissolution test of drug products. Therefore, it could be considered to revise the related regulation in the future to provide a more precise basis.