

Drug approval strategies for China have fallen into one of two camps over the past decade. On one side are a number of sponsors that started doing business in China in the 1990s and even earlier. These early adopters know China well. They know its relationship-based culture, they know its regulatory climate and nuances. This insider knowledge allows them to develop domestic Chinese approval strategies in conjunction with their global strategies and do well on both sides.
But most pharma and biotech firms are relative newcomers to the Chinese market and aren't aware that the regulatory climate has changed dramatically in recent years. Companies that do not have a physical presence in China may not have noticed, but SFDA approval times for Clinical Trials Approvals have dropped to between seven and nine months for small molecules. The 12-month approval that was once a miracle of speed has now become the limit of acceptability.
There are also opportunities in China for sponsors that have not yet completed Phase II trials to create a similar parallel approval strategy. They may not have the final details such as the final dosing to be used, but it is possible to file a CTA for Phase III based on the most current early phase results. This more limited parallel submission strategy can shave several months from the final approval time in China.

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In the podcast, Kent Thoelke, Executive Vice Presdient, Scientific & Medical Affairs for PRA, discuss parallel drug development strategies in China, the nuances of the regulatory market there, as well as best practices.