Chinese authorities are understandably cautious. The authorities recognize the benefits of conducting clinical trials for new drugs from multinational pharmaceutical companies. Through clinical trials, they expect Chinese patients will have access to new treatments and multinationals will bring in advanced management experience, research and training on drug research and development. However, Chinese authorities are concerned about patient welfare. Therefore, SDA authorities state that they are even stricter with review of an application relating to clinical trials than with application materials related to manufacture. As a result, new drug research and development is hindered, and Chinese patients have less access to newer medicines.
