A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member institutes. It will greatly accelerate and simplify the clinical study process, especially for multi-center clinical studies.
In China, all the clinical studies should be reviewed by the ethics committee in the relevant hospital or institutions. As for multi-center clinical studies in China, a same study will be reviewed by multiple ethics committees.
This repetitive review process may give rise to various problems, such as long waiting time, different application forms, different requirements, different examination standards, etc. In this case, the clinical process will be prolonged as well. The clinical trials are expedited after establishment of the recognition alliance.
Takeaways of the Beijing Ethics Committee Review Mutual Recognition Alliance
- Members of the Alliance will follow unified working rules
- Members of the Alliance will recognize the ethical review following an agreed review frequency and time
- Avoiding repeated ethical reviews
- Saving time for manufacturers and investigators
China Med Device
For more information regarding China Med Device, ethics committees, or for a list of these fifteen member institutions on the Beijing Ethics Committee Review Alliance, please email info@ChinaMedDevice.com.