Overall analysis of Chinese materia medica with clinical approval by CFDA during 2010-2015 / 中草药

ABSTRACT

The article provides the references for R&D direction of Chinese materia medica (CMM) by searching and sorting the clinical approval of CMM in China. The overall analysis on CMM includes the total amounts, register classifications, indications, declared periods, formulations of approved herbal medicines, and potential reasons of their regularities. The annual approval amounts during 2010-2015 are obviously decreased in the past 6 years. Approved medicines (83.75%) are compound recipes that belong to the sixth class in register classifications. Involving indications, the total amounts of approved medicines from respiratory system, digestive system, cardio-cerebrovascular system, gynecology, and skeletal musculature system are accounted for 70.03% of total number. The calculated average declared period is 27.36 months, while the applications of endocrine, nutrition, metabolism disease, and cancer system have much longer declared periods than the others. Most formulations of approved medicines are solid oral preparations such as tablets, capsules, granules, and it displays a big difference in formulations between different therapeutic domains. Overall, the registration approval analysis reflects to a certain extent that now is the difficult time of CMM research and development as well as approvals, the new drug R&D should pay more attention on its clinical value.