Situations and opportunities of new drugs of Chinese materia medica under background of globalized research and development / 中草药

ABSTRACT

Since China joined International Conference on Harmonization (ICH) in 2017, the research and development standards of new drugs have been formally in line with the international standards, and the innovation and development of chemical and biological drugs in China have entered a new era. However, compared with chemical drugs and biological drugs, the research and development of new drug of Chinese materia medica (CMM) is slightly insufficient, the number of new drug applications and approvals is not large, and the growth of industrial output is slowing down, which is caused by the global economic slowdown and the improvement of research and development rules and standards with China's accession to ICH. At present, CMM is supported by national policies, and the coming of the era of great health has brought great opportunities for the development of traditional Chinese medicine (TCM). Pharmaceutical enterprises should follow the trend and strive to improve the supply side level of pharmaceutical products of TCM. At the same time, we should correctly understand the difficulties, challenges and opportunities in the development of CMM, and strengthen the pharmaceutical innovation and secondary research and development of CMM. It is of great significance for the healthy development of CMM industry in the new era to analyze the situation faced by the research and development of CMM under the background of globalization, and analyze the difficulties, opportunities and challenges in the research and application of new drugs of CMM.