Pharmaceutical advertising regulation in China: framework and implications for Chinese and foreign enterprises

This thesis analyzes the legal framework governing pharmaceutical advertising in China, starting from its cardinal regulation, the Advertising Law, which establishes the fundamental ethical principles, content requirements, and a detailed section of penalties. Additional key provisions are contained in the Drug Administration Law, which initiated the centralization of pharmaceutical regulation. Within this system, responsibility for legal enforcement is shared between national and local authorities. Because pharmaceutical products directly affect public health, the legal requirements governing both domestic and foreign pharmaceutical companies are stringent. Enterprises seeking to manufacture and distribute drugs in China must follow rigorous procedures and provide the essential documentation, in order to ensure drug quality, safety, and traceability. The thesis examines these requirements through the analysis of different laws, which outlines the certifications, licenses, and practices necessary for drug commercialization. It also discusses the drug approval process, drawing on the Provisions for Drug Registration for the domestically produced drugs, and the Provisions for Drug Importation for foreign products. Similar to drugs that may only be marketed after undergoing a review process, pharmaceutical advertisements also require prior approval: applications are accepted only when the content and supporting materials comply with the requirements. Overall, the complexity and stringency of China's pharmaceutical advertising framework reflect the government’s commitment to protect public health and consumer rights.