The days appear to be over when obtaining regulatory approval for clinical trials in China generally took a year and often longer. Clinical trials can now pass regulatory review within 60 working days, which has been confirmed by more than 150 real cases.
To encourage innovation and investment into the creation of new drugs, the Chinese National Medicinal Products Administration (NMPA) implemented its new 60-working day IND review system in July 2018. Under its new process, the Chinese Center for Drug Evaluation (CDE) has 60 days to review a clinical trial application from the date of acceptance and payment. If the CDE does not issue a rejection or seek additional information within that 60 days, then the application is considered approved and the clinical trial may proceed according to the submitted plan.
We analyzed more than 160 clinical trial applications posted on the CDE website that were submitted between July 27, 2018, and April 8, 2019. For the majority of these studies, the review time was less than 60 days, with an average as low as 47 days for one drug category. This time was true regardless of whether the studies were filed by foreign or domestic sponsors or categorized as chemical drugs or biologics.
This analysis proves that regulatory approval is no longer a rate-limiting step for clinical study initiation in China. That is not to say, however, that there aren’t hurdles remaining. There are still challenges to initiate studies as quickly as in other countries, including with tasks such as completing ethic review by the institutional review boards and obtaining approval from the bureau controlling the collection of human genetic information.
The data below indicates the time taken by Chinese regulatory authorities for review. In most cases, the time required was less than 60 days, whether for chemical or biological products, IND, confirmatory trials, or ANDA applications.
Review Timeline Analysis for Imported Drugs
Review Timeline Analysis for Local Drugs
Review Timeline Analysis for Clinical Trial Application in China