Fig. 4

Number of chemical drug applications accepted by the CFDA from 2009 to 2012. 1. Data source: 2013 China Drug Review Annual Report. 2. Category 1.1 refers to new chemical drug which has never been previously approved for marketing as a drug anywhere else in the world. Category 3 of Chemical Drugs refers to a new drug which has only been marketed outside of China. Category 4 refers to Drug substance and its preparation with changed acid or alkaline radicals (or metallic elements), but without any pharmacological change, and the original drug entity already approved in China. Category 5 is defined as Drug preparation with changed dose form, but no change of administration route and the original preparation already approved in China. Category 6 refers to Drug substance or preparation following national standard