The Chinese government recently released new regulatory measures for clinical trials at medical institutions. The document lays out a strengthened code of conduct for hospitals and doctors conducting clinical trials. Companies that are carrying out clinical trials at Chinese hospitals should ensure that their policies and processes comply with the new laws.
Regulations already in place required certified hospitals to utilize Good Clinical Practices, an ethics committee review process and a clinical trial authorization system. According to the new regulations, each hospital must establish a clinical study administrative division and a clinical study administration committee, which will oversee and periodically evaluate the hospital’s trials. Trial funding must follow certain rules and be handled through a dedicated account. All clinical studies must be approved by both the administration committee and the ethics committee; the project must then be filed with local government offices within 30 days.
In mid-December of 2014, China announced that it would streamline the review and approval process for U.S. pharmaceutical products over the next several years.
China released a draft guideline for multi-regional clinical trials (MRCT). To use the results from a MRCT in support of drug registration in China, the trial sponsors will need to assess both the overall data as well as the Chinese patient population in the trial. The number of patients enrolled in China should be statistically significant and should be representative of China’s overall population.
China also released a draft law that would lift all drug price controls, likely in early 2015. However, this would only affect approximately 30% of drugs sold in China, as the majority of drugs are sold through a hospital tendering process.