The State Food and Drug Administration (SFDA) recently officially released the 2009 Annual Report on Drug Registration Approval. The Annual Report consists of six parts: the drug registration management in 2009, the approved drug production and marketing in 2009, the approved drug clinical research in 2009, the drug approval of the key therapeutic areas in 2009, the drug registration application acceptance in 2009 and the concluding remarks, displaying the achievements and effects of drug registration in 2009.
The Annual Report expounded important measures that SFDA has taken for the drug registration administration in 2009 from the aspects of the improvement of the drug registration regulation system, enforcement of the drug research supervision, enhancement of scientificness, openness and transparency of technical evaluation and approval of drug for emergent use and prevention and control of infectious diseases.
The Annual Report shows that a total of 6,428 drug registration applications were accepted in 2009; of that 5,128 applications were rendered by domestic applicants, including 2,336 new applications and 2,792 supplementary applications; and 1,300 applications were from overseas applicants, including 614 new applications and 686 supplementary applications. In 2009, the SFDA reviewed and approved 792 registration applications for new drugs, changing dosage forms, generic drugs and imported drugs in accordance with the new Provisions for Drug Registration. Of that, 548 were chemical drugs, 92 were traditional Chinese medicines and 38 were biological products.
source: SFDA
