Background: Combination products refer to therapeutic or diagnostic products composed of medical devices, drugs, and biological products, which have good clinical benefits. However, combination products are not entirely suitable for being classified separately into the regulatory category. With the rapid development of combination products, related supervision is also facing challenges. The regulatory authorities have developed and applied methods such as regulatory science to better solve the challenges faced by combination product marketings. This study aims to analyze the combined product regulatory experience of various countries based on cross-country comparisons. Method: This study is based on comparative research, centered on “description, explanation, parallelization, and comparison” as the research steps. Through literature research and policy review, relevant research data of drug-device combination products are obtained, and homogeneous information is collected and sorted. Make parallel comparisons, summarize, and analyze. Result: Recent year, the combination products of the regulatory authorities have become more and more widely used. Although all justifications have realized the importance of combination product supervision and have begun to introduce relevant laws and regulations. The definition, classification, marketing pathway, and post-marketing supervision methods of combination products also vary by regulatory authority. The classification of the product and the corresponding listing path are mainly determined according to the main mode of action of the product. However, with the application of regulatory science, regulatory authorities have begun to carry out special quality requirements and post-marketing supervision for combination products. The FDA has developed post-marketing adverse event reporting, cGMP and other related SOP standards. EMA has created a comprehensive evaluation path for product evaluation and established a network of cooperation with academic institutions. NMPA is optimizing the relevant classification of combined products and speeding up the listing. Conclusion: Taking into account the development of economic globalization, the regulatory authorities should rationally apply regulatory science and other methods to achieve the standardized regulatory trend of combined products. Keywords: drug-device combination products, combination products, FDA, EMA, NMPA

背景:組合產品是指由醫療器械、藥物、生物製品共同組成的治療或診斷產品，具有良好臨床收益。但是組合產品不完全適合單獨歸入監管類別。随著組合產品的迅速發展，相關的監管也面臨著挑戰。監管部門開幷用了監管科學等方法來更好的解决組合產品上市面臨的挑戰，本研究旨在基于跨國比较來分析各國家的組合産品監管經驗。 方法:本研究以比较研究作爲基礎，圍繞“描述，解釋，幷列，比较”作爲研究步驟進行，通過文獻調研和政策梳理的方式獲取藥械組合產品的相研究資料，通過匯總整理，將同質信息進行幷列比较，總結歸納，進行比較分析。 結果:近年來，監管部門的組合產品應用越來越廣泛。雖然各個地區都意識到組合產品監管的重要性幷開始出臺相關法律法規。而組合產品的定義、分類，上市路徑和上市後監管方法也因監管部門而异。產品的分類和相應的上市路径主要根據產品的主要作用方式來確定。但是随著監管科學的應用，監管部門開始針對組合產品開展專門的質量要求和上市後監管。FDA 開發了上市後不良事件報告、cGMP 等相關 SOP 標準。EMA 爲產品評估創建了綜合評估路徑，幷建立與學術機構的合作網絡。NMPA 正優化組合產品的相關分類和加快上市。 結論:考虑到經濟全球化的發展，監管部門應该合理應用監管科學等方法來實現組合產品的標準化監管趨勢。 關鍵詞:藥械組合產品，組合產品，FDA，EMA, NMPA