The heads of three departments respond to questions from reporters about the revision of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China.

On January 16, 2026, Premier Li Keqiang of the State Council signed State Council Decree No. 828, announcing the revised Implementation Regulations of the Drug Administration Law of the People's Republic of China, which will be implemented starting from May 15, 2026. Recently, the leaders of the Ministry of Justice, the State Administration for Market Regulation, and the National Medical Products Administration answered questions from reporters regarding the Regulations. What provisions did the Regulations make regarding strengthening drug production management? Drug safety responsibility is more important than Mount Tai, and drug production is a crucial aspect of ensuring drug safety. In order to further regulate drug production activities and meet the needs of the pharmaceutical industry's development, the Regulations have improved relevant systems in the following aspects: Firstly, strict management of commissioned drug production is required. The holder of a drug marketing authorization is responsible for supplier audits, managing changes during drug production, and releasing drugs to the market, while also overseeing the commissioned production enterprises; and it clarifies circumstances where drugs can be produced in segments. Secondly, drugs marketed in China but produced abroad must meet the relevant requirements of Chinese laws and regulations during their production activities. Thirdly, the Regulations improve the management system for traditional Chinese medicine production. It stipulates that traditional Chinese medicine materials may be processed at their place of origin, and clarifies the management requirements for the production and sale of traditional Chinese herbal pieces and granules.