国家药监局修订孟鲁司特制剂说明书

Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Montelukast formulations to enhance public medication safety based on adverse drug reaction assessments [1][2] Group 1: Regulatory Changes - The NMPA requires all marketing authorization holders of Montelukast products to revise their instructions according to the new guidelines by March 12, 2026 [1] - The revisions must include updates to drug labels and any other content that aligns with the original approval [1] - Products manufactured after the filing date cannot use the original drug instructions [1] Group 2: Compliance and Enforcement - Marketing authorization holders must conduct in-depth research on the mechanisms of newly identified adverse reactions and implement effective measures for medication safety training [1] - Provincial drug supervision departments are tasked with ensuring compliance among marketing authorization holders regarding the instruction revisions and label updates [2] - The NMPA emphasizes that patients should carefully read drug instructions before use and adhere strictly to medical advice when using prescription medications [2]