Abstract
In the current context of China’s rapidly growing economy, multinational drug companies are investing significantly in research and development in China, a trend that has accelerated over the last 10 years. A robust regulatory framework, an abundance of highly equipped medical universities and large patient numbers in all therapy areas make China an increasingly attractive location to conduct clinical research. In addition, data from China are now accepted for inclusion in applications for market authorisation by regulatory agencies worldwide, including the Food and Drug Administration (FDA) in the US. Hence China is becoming an equal partner in global clinical development, a trend that is likely to grow significantly in the years to come.
Similar content being viewed by others
References
von Zedtwitz M. Managing foreign R and D laboratories in China. R D Manage 2004; 34 (4): 439–52
Fisher WA, von Zedtwitz M. Chinese R and D: naissance, renaissance or mirage? R D Manage 2004; 34 (4): 349–65
Good clinical practice (SFDA order No. 3). Effective 2003 Sep 1 [online]. Available from URL: http://www.sfda.gov.cn [Accessed 2006 Sep 8]
Regulations for the Administration of Adverse Drug Reaction Reports and Monitoring (SFDA & MOH order No. 7). Effective 2003 Mar 4 [online]. Available from URL: http://www.sfda.gov.cn [Accessed 2006 Sep 8]
Drug Registration Regulation (SFDA order No.17). Effective 2005 May 1 [online]. Available from URL: http://www.sfda.gov.cn [Accessed 2006 Sep 8]
Acknowledgements
No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Humphries, M., Niese, D. & Dai, P. China as a Growing Research Base for Innovation in Medicines Development. Int J Pharm Med 20, 355–359 (2006). https://doi.org/10.2165/00124363-200620060-00003
Published:
Issue Date:
DOI: https://doi.org/10.2165/00124363-200620060-00003