輸入藥品製造廠GMP符合性-PMF書面審查案新措施成效分析研究   全文下載

Survey on the Registration of Overseas Medicines Manufacturers during 2012-2015

輸入藥品製造廠（以下簡稱國外藥廠）於我國藥品優良製造規範（以下簡稱GMP）符合性之檢查方式，自91年開始實施國外藥廠實地查廠後，成為工廠資料（Plant Master File）書面審查（以下簡稱PMF書面審查）及海外實地查廠雙軌制；食品藥物管理署（以下簡稱TFDA）於102年1月1日起正式成為國際醫藥品稽查協約組織（The Pharmaceutical Inspection Co-operation Scheme，以下簡稱PIC/S）第43個會員後，為善用人力與提升管理效能，依風險管理原則導入國外藥廠管理新措施，合理調整不同劑型之PMF書面審查強度，並於102年1月30日公告修訂「國外藥廠工廠資料準備須知」；本研究報告分析101-104年間新措施實施前後之國外藥廠PMF書面審查案件的申請情形、審查時效及審查結果，結果顯示新措施實施後仍可有效地檢視國外藥廠之GMP符合性，且平均辦理天數自101年度的365天大幅下降至104年度的230天，管理效率顯著提升。本研究發現生物藥品類的PMF書面審查案件數呈現增加趨勢，另亦發現PMF書面審查申請案常見的不准備查原因，可供未來人員培訓及精進國外藥廠管理制度之參考。TFDA將持續強化國外藥廠GMP之監督與管理，進而確保輸入藥品品質，保障國人用藥安全。

Since 2002, the GMP compliance of manufacturers of imported medicinal products could be assessed by either desk-inspection (assessing the Plant Maser File, PMF review) or on-site inspection. After the Taiwan Food and Drug Administration (TFDA) became a formal member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Jan. 1st 2013, a new risk-based approach for assessing the GMP compliance of foreign manufacturers started to enhance management effectiveness and efficacy. Based on this, the requested documents for PMF review was adjusted by the risk of dosage forms, and the “Preparation Instruction on Application for a PMF Review” was revised and published on Jan. 30th 2013. This study collected and analyzed the reviewing effectiveness data and results of PMF applications from 2012 (before the new approach initiated) to 2015. The results showed the new approaches can still effectively assess GMP compliance of foreign manufacturers, while the average due-time of PMF review was significantly reduced from 365 days in 2012 to 230 days in 2015. TFDA will continually improve the supervising mechanism of GMP compliance of foreign manufacturers to ensure the quality and safety of imported medical products and to protect public health.