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药品说明书适老化及无障碍改革
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“流感神药”说明书为啥这么长长长长长长
Jing Ji Guan Cha Wang· 2026-01-02 05:41
Core Viewpoint - The article discusses the issue of excessively long medication instruction leaflets, highlighting the confusion and frustration experienced by patients due to the complexity and size of these documents [2][5]. Group 1: Medication Instruction Leaflets - The instruction leaflet for Roche's Marbofloxacin is noted to be 60 centimeters long, with the longest instruction leaflet for any Roche drug in China reaching 1 meter [2]. - A patient expressed that the instruction leaflets are often overwhelming, with one stating that the information on adverse reactions is more daunting than the illness itself [5]. - The instruction leaflets are primarily designed for healthcare professionals, and a higher volume of information typically indicates more thorough scientific research behind the medication [5]. Group 2: Specific Examples of Instruction Leaflets - The longest instruction leaflet encountered by a pharmacy professional is for Merck's Pembrolizumab (commonly known as "K drug"), which totals approximately 2 square meters when unfolded [5][6]. - The instruction leaflet for "K drug" includes 12 cancer types and 19 indications, necessitating the presentation of over 70 charts due to the complexity of treatment protocols and patient-specific factors [6].
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]