我國輸入原料藥許可證GMP符合性之分析

Survey on the GMP Qualification of Imported Active Pharmaceutical Ingredients

藥品品質管理首重源頭管理，其中原料藥品質良莠更是重要關鍵，實施原料藥GMP無疑是提升藥品品質的重要手段，為確保藥品品質與民眾用藥安全，衛生福利部於102年9月25日公告「西藥原料藥製造工廠實施藥品優良製造規範之方法及時程」，領有許可證之輸入原料藥其製造廠必須於104年12月31日前經檢查符合GMP。食品藥物管理署（以下簡稱食藥署）自103年9月30日開始辦理領有許可證之輸入原料符合GMP檢查，截至104年12月31日止，應辦理GMP符合性檢查之1,755張輸入原料藥許可證中，提出檢查申請之許可證共計1,632張（佔許可證的93%），檢查結果計有1,275張通過GMP符合性檢查（佔申請檢查之許可證79%），共來自32個國家、計529家藥廠，主要來源國家為中國大陸及印度（合計約佔6成），與全球原料藥供應市場一致。透過辦理輸入原料藥許可證之GMP檢查，有效防堵非GMP之原料藥進入台灣，食藥署亦將持續強化輸入原料藥GMP之後續追蹤管理，以確保民眾用藥安全及品質。

To ensure the safety, quality and efficacy of medicinal products for human use, it is important for active pharmaceutical ingredients (APIs) to be manufactured in accordance with good manufacturing practice (GMP). On 25 September 2013, the Ministry of Health and Welfare has officially announced the rules and timeline of GMP implementation for the manufacture of APIs. From 1 January 2016, all active substances imported into Taiwan have to be manufactured in accordance with GMP. The Taiwan Food and Drug Administration (TFDA) is responsible for verifying GMP compliance since 30 September, 2014. As at 31 December 2015, 1,632 of 1,755 (93%) imported product licenses of APIs have applied and been reviewed for GMP compliance. 1,275 of 1,632 (79%) were found to be GMP compliant. In total, there are 529 qualified manufacturers from 32 countries that supply APIs to Taiwan. The top two countries, China and India, account for 60% of the manufacturers, which is a proportion similar to the global API supply market. The verification of GMP compliance is effective in preventing non-GMP APIs from entering Taiwan. The TFDA will continue to enhance the follow-up management of imported APIs to ensure the safety and quality of medicinal products.