New drug approval in 2013 released by CFDA

In 2013, there were 4875 manufacturers of APIs and preparations in China; in 2013, 148 new drugs were approved for clinical use, 4 new drug certificates, 66 approval numbers and 45 new drug certificates and approval numbers Drug registration in 2013, 148 new drugs were approved for clinical use, 4 new drug certificates, 66 approval documents, 45 new drug certificates and approval documents (among them, according to the provisions of the measures for the administration of drug registration, 0 varieties are approved for production and 0 varieties are approved for clinical use in categories 1 to 5 in the registration classification of traditional Chinese medicine and natural drugs; 2 varieties are approved for production and 82 varieties are approved for clinical use in categories 1.1 to 1.5 in the registration classification of chemical drugs; 1 variety is approved for production and 4 varieties are approved for clinical use in Category 1 in the registration classification of biological products.) In 2013, 120 clinical applications, 0 new drug certificates, 6 production certificates and 32 production certificates were approved according to the new drug application procedure In 2013, 92 clinical applications for generic drugs and 176 production applications were approved In 2013, 251 clinical applications for imported drugs and 17 listing applications were approved In 2013, the General Administration approved 2055 supplementary drug applications and 530 for filing A total of 5385 supplementary drug applications were approved by all provincial bureaus and 20153 were filed In 2013, the General Administration approved 571 applications for the production of packaging materials and containers in direct contact with drugs, 506 applications for re registration, 19 applications for import supplement, and 140 applications for domestic supplement.