Retrospect and Prospect of Research and Development of Chinese Medicines
as New Drugs in China
Abstract
Background and Purpose: Chinese materia medica is an important part in
China’s medical system, and the authority has issued a series of
regulations and guiding principles to improve the quality of research
and development (R&D) of new Chinese drugs. Approach: Investigational
new drug (IND) and new drug application (NDA) applications of new
Chinese medicines and approval condition were analyzed in 4 categories
including number of applications, review conclusions, registration
classification and therapeutic area from 2007 to 2022. Key Results:The
overall number of IND and NDA acceptance and approval of Chinese materia
medica is far less than that of chemical drugs and biological
preparations. The 6th classification of traditional Chinese medicine was
the most in the INDs and NDAs accepted by drug evaluation authority,
with a total number of 889 cases, accounting for 76.6% of all the
accepted cases, indicating that the difficulties and risks of R&D of
this type were relatively low. Conclusions & Implications: China is
still left behind in the aspect of drug R&D by developed countries. The
problems about relevant regulations, trial quality, selection of
efficacy and safety evaluation indicators and review evidence system
should be paid great attention to in the future research on Chinese
materia medica.