DAL

Origin

The Drug Administration Law has its roots in China’s centralized efforts to modernize its healthcare and pharmaceutical sectors, with a major revision passed in 2019 to align domestic standards with international best practices. This revision introduced key concepts like the Marketing Authorization Holder system and conditional approval pathways. The original purpose was to establish a clear, enforceable regulatory hierarchy to ensure public health and drug quality. This modernization was a critical step for global pharmaceutical integration.

Mechanism

The DAL operates by empowering the National Medical Products Administration to enforce stringent regulatory oversight, including pre-market approval, dynamic post-market surveillance, and severe penalties for non-compliance. The law mandates that Marketing Authorization Holders are ultimately responsible for the drug’s safety and efficacy throughout its entire lifecycle. This legal mechanism ensures that hormonal drugs, from raw API to patient consumption, adhere to strict quality control and therapeutic standards.