ABSTRACT
China’s pharmaceutical landscape has historically preferred generics where possible and secured high margins on them despite significant quality control issues. China, as the world’s most populous country, has experienced and is continuing to experience rapid evolution. There is a saying that China is “getting old before getting rich,” which is a telling way to illustrate some of China’s challenges with the proportion of elderly quickly growing and persisting inequity as urbanization continues. From a clinical trial perspective, overseas trial data can be used in China for clinical evaluation of certain therapies, waiving the need for a local study. Additionally, a faster clinical trial authorization process has resulted from implementation of a 60-day trial review and a rule allowing approval in the absence of timely Center for Drug Evaluation comments. Drug pricing and reimbursement falls within the purview of the National Healthcare Security Administration.
