药品说明书适老化及无障碍改革
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国家药监局局长李利:加快临床急需境外新药、罕见病药品、儿童药品等审评审批
Hua Er Jie Jian Wen· 2025-12-10 14:00
Core Viewpoint - The head of the National Medical Products Administration, Li Li, emphasizes the need to strengthen public awareness and accelerate the fulfillment of clinical medication demands [1] Group 1: Regulatory Approaches - The administration plans to fully utilize breakthrough therapy drugs, conditional approvals, priority reviews, and special approvals to expedite the review and approval of urgently needed overseas new drugs, rare disease medications, and pediatric drugs [1] - There is a commitment to maintain high standards and procedures while steadily expanding the scope of consistency evaluations for the quality and efficacy of generic drugs [1] Group 2: Patient-Centric Initiatives - The administration aims to shorten the distance from laboratory innovations to patient care, ensuring that innovative results benefit the public more quickly [1] - Efforts are being made to promote age-friendly and barrier-free reforms in drug labeling, encouraging the provision of accessible versions of drug instructions [1]