國際藥品警訊監測管理現況分析   全文下載

Analysis of Status on International Pharmaceutical Alert Monitoring and Management System

為加強上市後藥品品質之管理，各國衛生主管機關透過多樣化機制，包括製造廠之定期及不定期查核、上市後監控、藥品警訊系統及藥品回收等機制，確保製造廠在適當管控之條件下製造符合規格之藥品，保障消費者用藥之品質及安全。食品藥物管理署（以下簡稱食藥署）近年積極建置藥品警訊系統，除透過國際醫藥品稽查協約組織（Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme，PIC/S）之快速警訊平台、歐洲醫藥品品質審查委員會（European Directorate for the Quality of Medicines，EDQM）及輿情、代理商自主通報等多元管道接收警訊外，並主動查詢國外衛生主管機關發布之違反GMP警訊，對於警訊涉及之藥品或製藥廠，依風險等級執行對應之後續處理。本研究分析107年至110年間製劑及原料藥之相關警訊案件數、來源及後續處理情形，結果顯示主要來源為PIC/S快速警訊平台，以藥品品質瑕疵回收之警訊為主。另，GMP警訊案件以原料藥製造廠為大宗，占所有案件之65%。食藥署將持續與各國衛生主管機關雙向交流警訊，即時掌握警訊來源並處理，健全我國藥品警訊監控系統，確保藥品之品質與安全。

To strengthen the quality management of post-marketing medicinal product, the regulatory authorities worldwide use various mechanisms, including periodic, unannounced inspections of pharmaceutical manufacturers, post-marketing monitoring mechanisms, medicinal product alert systems and recall mechanisms to ensure that the drug products produced by the pharmaceutical manufacturers are under proper control, and thus, safeguard the quality and safety of medicinal product for consumers. The Taiwan Food and Drug Administration (TFDA) has been actively establishing a drug alert system in recent years. Other than receiving alerts from the rapid alert system of the International Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), The European Directorate for the Quality of Medicines (EDQM) and channels, such as public opinion and pharmaceutical agent self-report, the TFDA also actively searches for the GMP noncompliance alerts issued by foreign health authorities. For the medicinal products or the pharmaceutical manufacturers involved in the alert, the TFDA takes follow-up actions according to the risk level of the alert. This study analyzes the numbers, sources and follow-up actions of medicinal product, and API related alert cases between 2018 and 2021. The results show that the main source is the PIC/S rapid alert system, and among the alerts it delivered, issues related to drug quality defect account for the largest share. In addition, of all the GMP noncompliance notification, API manufacturers account for 65% of all cases. The TFDA will continue to exchange alerts with other regulatory authorities, deal with alerts in a timely manner, and improve the drug alert monitoring system, and therefore, ensure the quality and safety of drugs.