奈米藥品上市管制與藥品安全論

Abstract

奈米醫療係使用奈米技術以改良現有治療方式，或創造新的治療方法的奈米技術次學科領域。隨著化學、物理、材料科學、工程學和生物學領域之快速發展，奈米醫療研究與商品化醫療藉由奈米技術之跨學科整合而快速崛起，並為醫療照護產業帶來重大變革：建構個人化醫療與醫療產品多功能化，並進一步實現預防醫學之概念。 鑒於奈米醫療相關新技術之應用，將擴大、延伸藥物、生物製劑、複合式產品等之範圍，故將產生舊有的藥事法規範架構是否仍合適，或足以規範奈米產品之問題。因此，本文透過美國藥事法規之簡介與分析，以探討我國奈米藥品上市管制規範是否健全。 更進一步者，著眼於奈米材料欠缺相關的基礎毒理學資訊與成熟的檢測技術，故奈米材料影響健康的風險程度，因欠缺足夠的背景資料，而具有高度的不確定性。在面對奈米材料應用尚無法被證實為危險，卻又無法確認其屬無害的情況下，本文比較「藥品查驗登記」、「美國藥品設計瑕疵責任」與「我國藥害救濟法」三者所採行的「藥品安全」概念與試驗方法，透過藥品安全內涵之解析，以確保我國民眾用藥安全與奈米新藥發展間，能取得良好的平衡點。

Nanomedicine is the sub-discipline of nanotechnology striving to use this technology to improve existing therapeutics or create new ones. By taking advantage of the development of chemistry, physics, materials science, engineering and biotechnology, the interdisciplinary integration of nanotechnology promotes the research and commodification of medicine and brings significant change in medication. In other words, Nanotechnologies are the extensions of existing therapies and products that are already regulated: drugs, devices, and biologics, as well as combination products. Because this raises the pressing question of whether existing oversight frameworks and regulatory approaches are adequate and appropriate for nanomedicine, this article explored the regulations in U.S. and Taiwan to review the derived problems of nanodrugs. Further, due to lack of fundamental research of nanotoxicology and mature detecting and analyzing technique, nanomaterials are criticized to pose a great potential of risk of harm for human with a high degree of uncertainty. In such status of “non liquet,” this article tried to exploring the so called “safety” of drugs by comparing the concepts of safety in premarket approval of drugs, the design defect in product liability in U.S. and the implied concept in Drug Hazard Relief Act in Taiwan, to seek a balance for the safety of patients and new drug development in Taiwan.