Consideration about chemistry, manufacture and control (CMC) key problems in simplified registration of classical traditional Chinese medicine excellent prescriptions.
10.19540/j.cnki.cjcmm.2017.0073
- Author:
Zhi-Min WANG
1
;
Ju-Yan LIU
2
;
Xiao-Qian LIU
1
;
De-Qin WANG
3
;
Li-Hua YAN
1
;
Jin-Jin ZHU
1
;
Hui-Min GAO
1
;
Chun LI
1
;
Jin-Yu WANG
1
;
Chu-Yuan LI
2
;
Qing-Chun NI
4
;
Ji-Sheng HUANG
4
;
Juan LIN
3
Author Information
1. National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
2. Guangzhou Pharmaceutical Holdings Limited, Guangzhou 510103, China.
3. Guangzhou Baiyun mountain Hutchison Whampoa Chinese medicine Corporation Limited, Guangzhou 510515, China.
4. Guangzhou Pharmaceutical Research Institute Corporation Limited, Guangzhou 510240, China.
- Publication Type:Journal Article
- Keywords:
chemistry, manufacture and control (CMC);
research and development strategies;
supervision and administration;
traditional Chinese medicine;
classical TCM excellent prescriptions (cTCMeP)
- From:
China Journal of Chinese Materia Medica
2017;42(10):1819-1824
- CountryChina
- Language:Chinese
-
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 (cTCMeP) are the most valuable part of TCM system. To support the research and development of cTCMeP, 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 cTCMeP 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 cTCMeP 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 cTCMeP, instead of Standard Decoction method in Japan. "Totality of the evidence" approach, mass balance and bioassay/biological assay of cTCMeP 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.
