Quality design, quality improvement and evaluation requirement by stages on new traditional chinese medicine compound preparation
10.7501/j.issn.0253-2670.2017.16.001
- Author:
Chang-Ming YANG
1
Author Information
1. Center for Drug Evaluation, China Food and Drug Administration
- Publication Type:Journal Article
- Keywords:
Drug evaluation;
Evaluation requirement by stages;
New drug;
Quality design;
Traditional Chinese medicine compound preparation
- From:
Chinese Traditional and Herbal Drugs
2017;48(16):3253-3258
- CountryChina
- Language:Chinese
-
Abstract:
Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form and method of clinical medicine of CMM, the main categories and direction of the research and registration of new CMM products, the important part of “inheritance and development” of CMM culture, and mainly reflects the characteristics of CMM. According to the evaluation practice for many years, the research path and the knowledge of the research rules for new drugs of CMM compound were discussed, and the requirements for pharmaceutical research works of new CMM compound preparation. The pharmaceutical research on new CMM compound preparation is a process of quality design and quality improvement. The evaluation requirements of different stages for new CMM compound preparation were elaborated. It is the conclusion that the discussion of R&D path, R&D law, and R&D strategy on new CMM compound preparation will improve the technical evaluation standard system with the characteristics of CMM, increase the ability of R&D for CMM new products, promote the innovation of CMM, and accelerate the new CMM products to go on market.
