The research and development progress and all relevant technical requirements about new Chinese medicines since the release of Provisions for Drug Registration(2007 Version) were reviewed and summarized in this paper. To promote the healthy deve-lopment of regulatory agencies and the traditional Chinese medicine industry, the author conducted a comprehensive analysis on the advantages and disadvantages of the current technical requirements for new Chinese medicines and some typical cases in technical review, and put forward some constructive suggestions on the philosophies of traditional Chinese medicine review and the resolution of some technical disputes.
Keywords: drug review; regulatory; technical requirements; traditional Chinese medicine.