However, information on the output of innovative drug R&D in China is limited. With the aim of addressing this issue, we have collected and analysed information from the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA (CDE) for all novel pharmaceuticals for which new drug applications (NDAs) and investigational new drug applications (INDs) were approved in China between 2003 and 2010. The novel pharmaceuticals discussed in this article only include chemical drugs in classes 1.1 and 1.2 and biological drugs in class 1, which are defined by the SFDA as not being previously approved for marketing as a drug anywhere else in the world. Thus, the scope of novel drugs in this article is narrower than that of the new chemical entities (NCEs) used by the US Food and Drug Administration (FDA). For example, if a drug was first approved by the FDA or the European Medicines Agency, it would not be qualified as a class 1 new drug by the SFDA when its approval is later sought in China. Multinational pharmaceutical companies usually market their drugs in developed countries first, and in our survey, all the innovative drugs approved as class 1 by the SFDA are from domestic Chinese pharmaceutical companies. Consequently, the class 1 approvals by the SFDA reflect the status of innovative drug development solely in domestic Chinese pharmaceutical companies. Additionally, traditional Chinese medicine and vaccines are not discussed here.

Analysis

Enjoying our latest content?
Log in or create an account to continue

  • Access the most recent journalism from Nature's award-winning team
  • Explore the latest features & opinion covering groundbreaking research
Access through your institution

or

Sign in or create an account
Continue with Google
Continue with ORCiD