Approvals of Pharmaceutical Drugs in China in the Post-Drug Registration Regulation II Era.

Abstract

To delineate the impact of the revised Drug Registration Regulation (DRR II) issued in 2007 on drug approval in China and reveal the change in approval situations for new drugs and generic drugs in the post-DRR II era (2007-2011). Data of drug approvals were collected from the database of the China Food and Drug Administration (CFDA) and were analyzed by introducing 3 ratio indicators and utilizing statistical analysis tools. In the post-DRR II era, the drug approvals showed a general trend of the following: (1) a statistically significant rise in both the absolute number and proportion of new drugs, (2) a nonsignificant change for drugs in new dosage forms, and (3) a statistically significant drop in both the absolute number and proportion of generic drugs. On the other hand, Class 1 (new chemical entities) drugs accounted for an extremely small proportion in new drugs. Except for the rise in gastrointestinal and cardiovascular new drugs, no significant changes were found in other therapeutic categories. Thanks to the DRR II, the aberration in Chinese drug registration has been terminated. Approvals for new drugs and high-quality generics are the main trends. Because of the severe paucity of Class 1 drugs, innovation and collaboration will be the main 2 themes for the Chinese pharmaceutical industry as well as the upcoming version of the DRR III in the near future.