Updated on 12 November 2014
Singapore: Clinical trials registered: 5,276
Growth in China's clinical research sector is projected to be around 20 percent as government is taking measures to streamline regulatory procedures. Investment on infrastructure is a continued effort. Having the presence of leading CROs like Quintiles and ICON, China is home to more than 100 small and midsized domestic CRO companies.
For regulatory approvals, new chemical entity approval timeline in China has been shortened to approximately 14 months and new biologics approval timeline is around 16 months after regulatory submission. Clinical trial sites are accredited by China State Food and Drug Administration (SFDA) and the start-up timeline for global trial in China takes nine months. SFDA is responsible for registration and supervision of drugs and Medical Devices and Center for Drug Evaluation (CDE) is authority for evaluation of drug chemistry. CDE review times range from four to 12 months.