李强签署国务院令，公布修订后的《中华人民共和国药品管理法实施条例》

Core Viewpoint The revised "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" aims to enhance drug research, registration, production, and safety management, effective from May 15, 2026. The regulations focus on supporting innovative drug development, improving drug quality, and ensuring safety in drug management. Group 1: Drug Research and Registration - The regulations support drug research and innovation guided by clinical value, encouraging the development of new drugs and their clinical promotion [1][3] - A fast-track registration process for drugs is established, along with clear procedures for re-registration and mechanisms for converting prescription drugs to over-the-counter status [1][12] - Special market exclusivity periods are granted for pediatric drugs and treatments for rare diseases, with data protection for drugs containing novel chemical components [1][14][15] Group 2: Drug Production Management - The regulations enforce strict management of drug production, emphasizing the responsibilities of drug license holders during contract manufacturing [1][24] - Specific management requirements for traditional Chinese medicine (TCM) products are outlined, including production and sales regulations [1][29] Group 3: Drug Safety Regulation - Enhanced drug safety supervision measures are specified, including detailed procedures for quality inspection and the right to request re-examination of inspection results [2][50] - Legal responsibilities for violations are clearly defined to ensure compliance and accountability in drug management [2][52] Group 4: Drug Distribution and Use - The regulations improve the management of online drug sales, holding third-party platforms accountable for the quality of drugs sold [1][35] - Medical institutions are required to strengthen their drug management practices to ensure the quality of drugs used [1][49]