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| 題 名 | 琴澳一體化背景下中醫藥產品註冊與流通監管銜接的挑戰與路徑優化=Challenges and Optimization of the Convergence of Chinese Medicine Product Registration and Distribution Supervision in the Context of Qin-Macao Integrationa |
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| 作 者 | 吳磊; 陳文博; | 書刊名 | 澳門法學 |
| 卷 期 | 2025:3=61 2025.09[民114.09] |
| 頁 次 | 頁127-140 |
| 分類號 | 412.24 |
| 關鍵詞 | 琴澳一體化; 中醫藥監管銜接; 跨境流通監管; 中藥材品質標準; 監管協同優化; Qin-Macao integration; Regulatory convergence of Chinese medicine; Cross-border circulation regulation; Quality standard of Chinese herbal medicines; Regulatory synergy and optimisation; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 琴澳一體化戰略推進下,橫琴粵澳深度合作區作為中醫藥國際化重要載體,其發展關鍵 在於琴澳監管體系有效銜接。澳門構建了以《中藥藥事活動及中成藥註冊法》為核心的多層次監管體 系,橫琴則遵循國家藥品法規並結合區域需求創新監管。現有合作實踐包括高層協作、“跨境通辦”服 務、“澳門監造/監製”模式及聯合品質檢驗機制。當前銜接面臨核心挑戰,如註冊審評效率與標準差 異、跨境生產鏈條法規障礙、非藥監管認定不一、中藥材品質控制薄弱等。為突破困境,可通過優化註 冊審評機制、創新跨境中間體監管模式、理順非藥分類管理、夯實中藥材品質基礎等路徑,構建琴澳聯 合標準,推動機制互認與協同監管,以支撐合作區中醫藥產業高質量發展並促進其國際化進程。 |
| 英文摘要 | Under the integrated development strategy for Hengqin and Macao, the Hengqin Guangdong-Macao Deep Cooperation Zone serves as a vital platform for the internationalisation of traditional Chinese medicine. Its advancement hinges critically on the effective alignment of regulatory frameworks between Hengqin and Macao. Macao has established a multi-tiered regulatory system centred on the Law on Pharmaceutical Affairs and Registration of Chinese Patent Medicines, while Hengqin innovates its oversight by adhering to national pharmaceutical regulations while addressing regional requirements. Existing collaborative practices encompass high-level coordination, ‘cross-border one-stop’ services, the ‘Macao Supervision/Manufacturing’ model, and joint quality inspection mechanisms. Current integration faces core challenges, including disparities in registration review efficiency and standards, regulatory barriers in cross-border production chains, inconsistent non-drug regulatory classifications, and weak quality control of Chinese medicinal materials. To overcome these obstacles, pathways include optimising registration review mechanisms, innovating cross-border intermediate substance regulatory models, rationalising non-drug classification management, and strengthening the quality foundation for Chinese medicinal materials. Establishing joint Hengqin-Macau standards, promoting mutual recognition of mechanisms and collaborative oversight will support the high-quality development of the Traditional Chinese Medicine industry within the cooperation zone and advance its internationalisation process. |
本系統中英文摘要資訊取自各篇刊載內容。