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  • 學位論文

論台灣與大陸生物藥品上市之安全性與品質管控規範及其比較研究−以基因工程製品為例

Safety and Quality Regulation of Biomedicine in Taiwan and China: Focus on Genetically Engineered Drug

指導教授 : 范建得
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摘要


隨著化學藥品引起的安全性、耐藥性問題日益嚴重,以及生物藥品能彌補化學藥物在治療領域中的不足,又有諸多優點,生物藥品的市場快速成長。本文研究基因工程藥品在台灣與大陸申請上市時分別在不同階段需遵循之法規、各該法規適用的範圍,惟因基因工程藥品為生物藥品之一種,故基因工程藥品需先符合生物藥品之規範,再視有無針對基因工程藥品之規定。   在非臨床試驗階段,兩岸針對非臨床試驗內容上之規範,皆係以毒性測試之管制為主,惟台灣之相關規範有更進一步針對進入非臨床試驗前之相關規範,而大陸則無。在非臨床試驗程序上之規範部分,台灣係以「藥物非臨床試驗優良操作規範」為主,大陸則是以「藥物非臨床研究質量管理規範」為主。針對生物藥品進入人體臨床試驗前,兩岸皆有相對應之規範,台灣由「藥品臨床試驗計畫書主要審查事項」加以規制,大陸則係由「藥品管理法」及「藥品管理法實施條例」加以規範;在執行臨床試驗階段,台灣之規範架構主要以「藥品優良臨床試驗準則」為主,而大陸則係透過「藥品生產品質管制規範」加以規範。 最後,為確保民眾用藥安全、提升藥品之品質,兩岸均針對作為國際通行的藥品生產質量管理基本準則之GMP提出應對應之規範,比較兩岸之規範,可發現台灣主要以「西藥藥品優良製造規範」為主,而大陸則為「藥品生產質量管理規範」為主,又再針對生物藥品之特殊規範部分,台灣係規範於「西藥藥品優良製造規範」之附件:「人用生物藥品的製造」與「藥品查驗登記審查準則-基因工程藥品之查驗登記」部分;而大陸則有「中國藥典」之生物製品包裝規程之規範、「中國藥典」之生物製品貯藏和運輸規程、「生物製品批簽發管理辦法」以及「人用重組DNA製品品質控制技術指導原則」加以規範。

並列摘要


As the problems of safety and drug tolerance of chemicals get ever more serious, the market of biomedicine grows rapidly to make up for the deficiencies of chemicals in remedial areas. Regulations in Taiwan and China and applications thereof which shall be followed through different stages when promoting genetic engineered medicine into market are discussed in this thesis. Since genetic engineered medicine is categorized as one sort of biomedicine, it should be in accordance with the rules set for biomedicine first and be further considered if regulations targeted to genetic engineered medicine exist. Taiwan and China mainly impose the control of toxicity measurement regarding the rules of content in nonclinical test. Taiwan has further related regulations before entering into nonclinical test, while China does not. The procedural regulations of nonclinical test in Taiwan is mainly stipulated in Good Laboratory Practice, and for China in Good Laboratory Practice (the translation is the same but it is different in Chinese). In Taiwan, Major Review items in Clinical trials of pharmaceuticals is set as the corresponsive rules before biomedicine goes under human clinical test. While in China, Veterinary Drugs Control Act and its Enforcement Statute for are the corresponsive rules thereon. The regulatory framework in Taiwan during clinical test is referred to Good Clinical Practice, and that in China is Good Clinical Practice (the translation is the same but it is different in Chinese). Finally, to ensure the safety of drug usage and increase the quality of medicine, Taiwan and China both make corresponsive regulations in accordance with the International standard of GMP (Good Manufactured Practice). After comparing with the regulations from both countries, it can be found that Taiwan mainly focuses on PIC/S: Guide to Good Manufacturing Practice for Medicinal Products while China concentrates in Good Manufacture Practice of Drugs.

參考文獻


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