The primary statute regulating pharmaceuticals in China is the Drug Administration Law (DAL). The latest DAL revision has been effective since 1 December 2019. The DAL, together with its implementing rules, referred to as the DAL Implementing Regulations, governs various drug-related activities, including drug development, registration, manufacturing, and distribution.

In order to address statutory requirements under the DAL for each of these activities, GxP (good practice) rules on laboratory, clinical trials, manufacturing, distribution, and pharmacovigilance (PV), as well as administrative measures on matters such as drug registration, manufacturing, distribution, and recall, have also been enacted. In addition, product-specific laws, rules, and guidelines, such as the Vaccine Administration Law and the Administrative Measures on Blood Products, also apply to the respective products. Some of the above-mentioned regulations and rules were updated in 2020, and some are still under revision in order to reflect the amendments under the DAL compared to the previous version.