Considerations of pharmaceutical research for new drugs of Chinese materia medica / 中草药

ABSTRACT

A series of policies to encourage innovative drug were issued and implemented in opinions of speeding up new drug review and approval by National Medical Products Administration, including application for drug clinical trials on 60 days of implied permission and the communication mechanism. In this article, we analyzed the adjustment of new drug review, and explained the necessity and difference in pharmaceutical research and development of Chinese materia medica (CMM), and illuminated the main problems and emphases in CMM pharmaceutical research in aspects of source of medicinal materials, production process, quality research and standards, expecting to provide reference for speeding up new drug review and benefit drug applicants.