Chinese patent medicines are widely used worldwide as herbal products. In the context of globalization, quality control of these products has become an increasingly important issue not only for the consumers but also for regulators and manufacturers. Laws, regulations and guidelines stipulating requirements of good manufacturing practice (GMP) of herbal products differ worldwide and harmonization is yet to achieve. This paper aims to study the design of international mainstream GMP standards of herbal medicines, the implementation of traditional Chinese patent medicine (TCPM) GMP in China by considering the behavior and impact of TCPM enterprises, further explore the development strategy for TCPM GMP in China. The research was carried out in two dimensions. Firstly, five of the major GMP standards of herbal products adopted in different countries and regions were compared though secondary data in terms of principles, contents, implementation, and performance. The GMP standards selected for this study include the WHO GMP, GMP in China, cGMP in the US, PIC/S in Singapore and GMP in the EU. Secondly, secondary data collection and interviews towards TCPM enterprises were carried out together to study the GMP implementation status of TCPM GMP in China. The implementation principle, contents, supervision and performance based on the change of the 1998 revised GMP to the 2010 revised GMP were studied in macroscopic and microscopic dimensions. Finally, comparisons between implementation in China and development of international GMP were carried out. The study found that the fives GMPs are developing parallelly in principles and contents, trending to quality risk management in the whole manufacturing process. But they also have major differences in the scope of products and the implementation mode. In China, the implementation investigation of TCPM GMP indicated that the principles and contents were transforming from fixed provisions-oriented operations to more flexible regulations including personnel training and the establishment of quality control system, basically similarly to the development of international GMP of herbal medicines. Yet, the performance of the new GMP were not obvious, the surveyed businesses responded with difficulties in the implementation process, and hoped that the basic integration of TCPM industry and the improvement in drugs’ quality should be completed till the acceptance period of the 2010 revised GMP in the end of 2015 as promised. International herbal iv medicines GMP standards would be a useful reference for the future development of traditional Chinese patent medicines GMP in China, especially when the mainland enterprises are trying to get involved in globe herbal medicine market.

中成藥如今在全球廣泛使用，其藥品安全性存在爭議，因此中成藥的品質 控制尤為重要。無論對藥品安全規範的制定者、中成藥的生產者抑或中成藥等 草藥產品的消費者，藥品質量控制都是不可忽視的重要問題。產品生產品質管 制規範（GMP）是保障中成藥品質的重要方法，產品管理規範又因各國家的要求 而有所區別。本文目的在於研究現金國際上主流的幾種草藥 GMP 標準的設計實 施方式，瞭解在現行 GMP 標準下我國中成藥生產企業履行 GMP 的具體實施行為 及 GMP 的實施對中成藥企業影響，從而深入探討我國中成藥 GMP 的發展策略。 研究將從兩個維度展開，首先通過二手資料收集等，研究五個不同國家的草藥 品質管制規範在原則、內容、實施監管和績效方面的區別，從而深入探尋中成 藥產品生產管理規範在整個醫藥市場中的設計實施情況。所選取的 GMP 包括全 球衛生組織（WHO）的 GMP，美國的 cGMP，中國的 GMP，國際藥品監察合作計畫 （PIC/S）規定下的 GMP（以新加坡為例）以及歐盟的 GMP。第二部分將採用檔 案數據蒐集及企業訪談的方法，研究我國中成藥 GMP 的具體實施情況，從宏觀 和微觀兩個層面全面瞭解在 98 版本和 10 版本 GMP 交替期間實施的原則、內容、 監管、績效等方面的意見，企業訪談將根據我國所採用的兩版 GMP 的具體內容 制定訪談提綱，對三家企業的 GMP 部門相關負責人進行訪談、收集信息，最後 將我國中成藥 GMP 的實施情況與國際間草藥 GMP 的發展情況相比較，得出更深 入的結論。研究發現，首先，五種 GMP 在原則和內容上均存在趨同性，趨向於 關注整個生產過程的品質風險管理。但是五種 GMP 在不同的地區，其具體執行 模式以及中成藥的定義範圍均有較大區別。其次，通過對我國中成藥 GMP 實施 情況的調研，中成藥 GMP 的實施原則和內容從“條文”導向式演進到更為靈活 的質量管理人才的培養以及品質風險管理系統的構建，正逐漸靠近國際主流草 藥 GMP 的發展方向，然而新版 GMP 的實施效果尚不明顯，企業反映了實施過程 中所遇到的難點，並且希望 GMP 的實施能夠更嚴格、內容更明晰，直到 15 年底 GMP 驗收期完成中成藥產業的基本整合和藥品品質的整體提升，對於中成藥 GMP 的未來發展戰略，增加與國際主流草藥 GMP 標準制定方的交流與合作是必不可 少的。