[Analysis on reasons for disapproval of registration application of new traditional Chinese medicines in recent years].

OBJECTIVE

To analyze reasons for disapproval of registration application of new traditional Chinese medicines in recent years and discuss potential problems occurring in R&D and registration administration of new traditional Chinese medicines in China.

METHOD

All applications of new traditional Chinese medicines for registrations that had been disapproved by Center for Drug Evaluation of State Food Drug Administration from 2006 to 2008 were searched in data bank. Specific reasons for disapproval of each variety were inquired and sorted out. The statistics involved the proportion of each type (kind) disapproval reasons in all disapprovals in order to analyze which were the main reasons. The results were analyzed to find out potential problems occurring in R&D and registration administration of new traditional Chinese medicines in China.

RESULT

There were totally 247 disapproved registration applications for new traditional Chinese medicines. Among them, there were 218 applications for clinical trials and 29 applications for launch in the market There were 9 categories (29 types) of reasons for the applications for clinical trials applications, mainly including such problems as R&D proposal, non-clinical effectiveness and non-clinical safety; while there were 5 categories (9 types) of reasons for the applications for launch in the market, with clinical effectiveness as the main reason.

CONCLUSION

There were many kinds of reasons for the disapproval registration applications of new traditional Chinese medicines in recent years in China, mainly including such problems as effectiveness, safety and proposal basis. This reflects problems occurring in R&D and registration administration of new traditional Chinese medicines in China to some extent.