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 Implementation Regulations of the Drug Administration Law of the People's Republic of China will take effect on May 15, 2026, aiming to enhance drug research, production, and safety management in the pharmaceutical industry [1][2]. Group 1: Drug Research and Registration - The regulations support drug development and innovation based on clinical value, encouraging the research and creation of new drugs [1] - A fast-track registration process for drug market entry is established, along with clear re-registration procedures and mechanisms for converting prescription drugs to over-the-counter status [1] - Special market exclusivity is granted for pediatric medications and treatments for rare diseases, along with data protection for drugs containing novel chemical components [1] Group 2: Drug Production Management - The regulations enforce strict management of commissioned drug production, clarifying the responsibilities of drug market license holders during the commissioning process [1] - Specific management requirements for the production and sale of traditional Chinese medicine pieces and formula granules are outlined [1] Group 3: Drug Operation and Usage - The regulations improve the management system for online drug sales, holding third-party platforms accountable for drug transactions [1] - Enhanced pharmaceutical management in medical institutions is mandated to ensure drug quality during usage [1] - Approval processes for the preparation of formulations in medical institutions are specified, supporting the preparation of pediatric formulations to meet the needs of child patients [1] Group 4: Drug Safety Supervision - The regulations clarify drug safety supervision and inspection measures, detailing the process for quality sampling and testing [2] - Strict legal responsibilities are established for violations, ensuring accountability within the pharmaceutical sector [2]