药物警戒是发现、评价、理解和预防药品不良反应或其他任何与药物相关问题的科学与活动。中国于2017年加入ICH后,接着新《药品管理法》第十二条明确规定了中国实行药物警戒制度。但资料显示,在ICH落地生效的两年中,中国5000家药企中仅10%建立了药物警戒的相关体系。药物警戒涉及MAH、经营企业、临床试验机构、监管部门、医疗机构、行业学协会、高校及科研机构、患者等,需要社会各界的共同参与,是一个“生态系统”,要依靠“社会共治”。因此,行业需要不断深化药物警戒的理念,加强制度实施。
<<Pharmacovigilance is the science and activity of discovering,evaluating,understanding and preventing adverse drug reactions or any other drug-related problems. After China joined ICH in 2017,Article 12 of the new “Drug Administration Law” clearly stipulates that China implements a pharmacovigilance system. However,data shows that only 10% of China’s 5000 pharmaceutical companies established pharmacovigilance related systems two years after China joined ICH. Pharmacovigilance involves MAH,operating companies,clinical trial institutions,regulatory agencies,medical institutions,industry associations,universities and scientific research institutions,patients,etc. It requires the participation of all sectors of the society. It is an “ecosystem” that depends on “social co-governance”. Therefore,the industry needs to continuously deepen the concept of pharmacovigilance and strengthen the implementation of the system.
<<Keywords: | Marketing Authorization HolderAdverse Drug ReactionsDrug Administration LawPharmacovigilance |