課程編碼 Course Code | 中文課程名稱 Course Name (Chinese) | 英文課程名稱 Course Name (English) | 總學分數 Credits | 總時數 Hours |
---|---|---|---|---|
6805069 | 生技相關產業優良製造規範 | Bio-technology Industry Related Manufacture Regulations | 2.0 | 2 |
中文概述 Chinese Description | 由於人口老化、國民所得提高、醫療支出增加與各種流行性傳染病等相關議題,生技相關產業已被世界公認為二十一世紀最具發展潛力之產業。下一波台灣的高科技產業應著重於以發明與創新為主的產業,而生技相關產業正是我國決定要發展之重大新興產業。由於生技相關產業應用範圍廣,附加價值高,故為提升其產業競爭力且加速進入國際市場,國內生技相關產業除了須提升產品品質、加強國際化的管理之外,亦須通過各國所採用的認證制度。此外,政府如何建構一健全完善的法規管理制度,更是生技相關產業發展成功的必要條件。目前國內醫藥產品相關法規,包括藥事法、醫療器材優良製造規範(GMP)及藥品優良製造規範(cGMP)等。由於近年國內外細胞療法之迅速發展,且人體細胞組織物之管理操作與傳統藥品並非完全相同之原因,我國特別訂定人體細胞組織優良操作規範(Good Tissue Practice,GTP),其目的為預防因使用人體細胞組織物而導入、傳播及擴散傳染病,並期望協助機構確保其人體細胞組織物未含有傳染病病原,在製造過程中未受污染,且不致因製造不當而影響人體細胞組織物效用與完整性。 | |||
英文概述 English Description | Biotechnology-related industry has been recognized as the most potential business in twenty-first century. The next step of Taiwan's high technology should focus on the invention and innovation-based industry, which biotechnology should be included. Medical technology is a high value-added, application-board industry. To enhance its competitiveness and speed up access to international markets, producers need to ensure the product quality, strengthen the international management, conformity the regulation in all different countries. At present, the relevant laws and regulations of pharmaceutical products include the followings: the Pharmaceutical Affairs Law, good manufacturing practice of medical device (GMP), pharmaceutical Good Manufacturing Practices (cGMP) and the rapid development of cell therapy and the management of human cells and tissues (Good Tissue Practice, GTP) . |
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