SFDA Cancelled Thousands of Drug Approval Documents
Year:2010 ISSUE:6
COLUMN:PHARMACEUTICALS AND BIOCHEMICALS
Click:327    DateTime:Nov.02,2010
SFDA Cancelled Thousands of Drug Approval Documents    

An official of the State Food and Drug Administration (SFDA) of China recently disclosed that SFDA cancelled around 4 300 items of drug approval documents in 2009 after checking the existing 170 000 items.
   SFDA accepted 33 000 applications for drug registration in 2009. Of that, 2 609 applications were approved, 15 000 applications were not approved and 7 999 applications were returned back to the applying companies.
   The approved applications involve 1 464 drug varieties. Of which, nine are novel chemical or biological medicines, innovative both at home and abroad. The approved 2 609 applications cover that of ten companies to manufacture H1N1 flu vaccine.
   It was reported that the number of applications fell dramatically in 2009, around 60% compared with 2007.