Analysis on application for registration of active fractions in Chinese materia medica during 2004—2007 / 中草药

ABSTRACT

The basic information,including the number of applications,dosage forms,indications,structure types,purification processes,medicinal materials,period of clinical trials,and dealing conclusions for registration of active fractions in Chinese materia medica(CMM) during 2004-2007,was analyzed.The numbers of registration for clinical trials and applications for production during 2004-2007 were 202 and 23,respectively.It could be found that the numbers of registrations of active fractions in CMM declined obviously since 2005 and the dosage form,indication,and purification process of those applications showed a trend of the relative concentration.From aspect of the stage conclusions,the rate of "not to approve" of applications for clinical trials and production were 48.0% and 8.7%,respectively.So,it could be concluded that the studies on the selection of dosage form,indication,and purification process of active fractions in CMM should be further strengthened.