China’s Center for Drug Evaluation has clarified its requirements for how pharmaceuticals manufactured outside its borders are tested in clinical trials.
Under the new requirements, China’s Center for Drug Evaluation (CDE) will continue to permit the importing of drugs successfully evaluated in clinical trials in the United States and other countries with advanced drug trial regulations, but that data may also be subject to verification by Chinese drug administration authorities.
If a trial conducted abroad is deemed to lack sensitivity to the epidemiology, severity, and prognosis of a disease in the Chinese population, the CDE will require that a new set of local clinical trials be conducted in China.