WANG Zhi-min;LIU Ju-yan;LIU Xiao-qian;WANG De-qin;YAN Li-hua;ZHU Jin-jin;GAO Hui-min;LI Chun;WANG Jin-yu;LI Chu-yuan;NI Qing-chun;HUANG Ji-sheng;LIN Juan;

• 1:National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines
• 2:Institute of Chinese Materia Medica
• 3:China Academy of Chinese Medical Sciences
• 4:Guangzhou Pharmaceutical Holdings Limited

Abstract：

As an outstanding representative of traditional Chinese medicine(TCM) prescriptions accumulated from famous TCM doctors' clinical experiences in past dynasties,classical TCM excellent prescriptions(c TCMe P) are the most valuable part of TCM system. To support the research and development of c TCMe P,a series of regulations and measures were issued to encourage its simplified registration. There is still a long-way to go because many key problems and puzzles about technology,registration and administration in c TCMe P R&D process are not resolved. Based on the analysis of registration and management regulations of botanical drug products in FDA of USA and Japan,and EMA of Europe,the possible key problems and countermeasures in chemistry,manufacture and control(CMC) of simplified registration of c TCMe P were analyzed on the consideration of its actual situation. The method of " reference decoction extract by traditional prescription"(RDETP) was firstly proposed as standard to evaluate the quality and preparation uniformity between the new developing product under simplified registration and traditional original usages of c TCMe P,instead of Standard Decoction method in Japan. " Totality of the evidence" approach,mass balance and bioassay/biological assay of c TCMe P were emphatically suggested to introduce to the quality uniformity evaluation system in the raw drug material,drug substance and final product between the modern product and traditional decoction.

Key Words： traditional Chinese medicine;classical TCM excellent prescriptions(cTCMeP);chemistry;manufacture and control(CMC);research and development strategies;supervision and administration

Abstract:

Keywords:

Foundation: 国家“重大新药创制”科技重大专项(2017ZX09201010-001);; 2015年中医药行业科技专项(201507002-2,201507002-3)

Authors: WANG Zhi-min;LIU Ju-yan;LIU Xiao-qian;WANG De-qin;YAN Li-hua;ZHU Jin-jin;GAO Hui-min;LI Chun;WANG Jin-yu;LI Chu-yuan;NI Qing-chun;HUANG Ji-sheng;LIN Juan;

DOI: 10.19540/j.cnki.cjcmm.2017.0073

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