What are the differences between China's GCP and ICH GCP?

There are six major differences between China's GCP and ICHGCP: First, clinical trials in China must be approved in writing by the SFDA before they can begin, whereas in some countries, such as the U.S. FDA, the drug administration approves clinical trials by tacit consent, i.e., "no news is good news". Secondly, there is a qualification access requirement for conducting clinical trials in China, and qualified clinical research institutions and specialties must be selected to conduct clinical trials, while ICHGCP does not have such a requirement. Third, only medical institutions are allowed to conduct clinical trials in China, while in other countries, contract research organizations (CROs) and independent clinical trial organizations or laboratories can conduct them. Fourth, China's GCP requires that the principal investigator of a clinical trial must be qualified to practice medicine, whereas ICHGCP only requires that the principal investigator be qualified to practice medicine or be able to be assisted by a person who is qualified to practice medicine. Fifth, China requires that investigators keep clinical trial data for 5 years after the completion of a clinical trial, while ICHGCP requires that the data be kept for more than 2 years. Sixth, China requires that the ethics committee be set up within the clinical trial organization, while foreign countries are often an independent third party.