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 Drug Administration Law Implementation Regulations will take effect on May 15, 2026, aiming to enhance drug research, production, and safety management in China [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 eligible pediatric medications and treatments for rare diseases, along with data protection for drugs containing new chemical entities [1]. Group 2: Drug Production Management - The regulations enforce strict management of commissioned drug production, clarifying the responsibilities of drug market authorization holders [1]. - Specific management requirements for the production and sale of traditional Chinese medicine (TCM) decoction pieces and formula granules are outlined [1]. Group 3: Drug Distribution and Usage - The regulations improve the management of online drug sales, holding third-party platforms accountable for drug transactions [1]. - Medical institutions are required to enhance pharmaceutical management to ensure drug quality during usage, with defined approval processes for compounded preparations [1]. Group 4: Drug Safety Supervision - The regulations specify measures for drug safety supervision and inspection, detailing the quality sampling and testing processes [2]. - Strict legal responsibilities are established for violations of the regulations [2].