药品生产及流通领域监管风险浅析

摘要

随着近年来药害事件的发生和公众对药品安全的日益关注,国家食品药品监督管理局加强了对药品安全性、有效性和质量可控性的监管,加强了对药品全生命周期的风险管理.在此背景下,通过对我国药品生产、流通领域监管存在的风险进行分析并提出建议,为我国药品生产、流通领域风险监管提供借鉴.%Recent years, the drug hurt events occurred frequently and the public concern about drug grown much.The State Food and Drug Administration stepped up the safety, effectiveness and control regulation for drug, and strengthened drug life-cycle risk management. From this point of view, the paper intend to come up to suggestion for the risk management in the pharmaceutical regulation area with the special analysis for pharmaceutical production and circulation risk.