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世卫组织:中国药监局调查长春长生行动迅速透明

7月25日,世界卫生组织就长春长生“狂犬病疫苗事件”发布媒体声明,称完全支持中国国家药品监督管理局(NDA)扣留问题批次狂犬病疫苗、使其不能进入市场的行动,并随时准备向中国国家卫生主管部门提供支持。

世卫组织赞扬中国国家药监局采取迅速而透明的行动,停止长春长生公司的生产并对事件展开调查。

世卫组织在2010年和2014年对中国国家药监部门进行过两次评估。结果显示国家药监部门达到了世卫组织充分行使职能的监管机构的标准,并明确承诺会继续改进。

世卫组织表示,欢迎中国国家药监局继续与世卫组织的加强国家监管部门的合作,这一合作已经开展了近20年。本次事件无疑令人遗憾,但此次事件由飞行检查发现,也说明了监管机构的体系监管和现场检查能有效保护人民健康。

【附】世卫组织关于中国狂犬病疫苗事件的媒体声明

北京,2018年7月25日 – 世界卫生组织(世卫组织)完全支持中国国家药品监督管理局(NDA)扣留问题批次狂犬病疫苗、使其不能进入市场的行动。

国家药监局在对位于中国吉林省的疫苗生产厂家——长春长生生物(11.750, 0.00, 0.00%)科技股份有限公司的生产场地进行飞行检查时,查出该公司在涉事批次狂犬病疫苗生产过程中存在记录造假的问题。政府已经扣留了所有涉事疫苗,避免给患者使用问题疫苗,并停止了该公司的疫苗生产。世卫组织正在等待进一步的调查结果,并随时准备向中国国家卫生主管部门提供支持。

“疫苗的监管极其重要,它是政府确保中国生产和使用的疫苗安全、优质和有效的主要手段,”世卫组织驻华代表高力表示。“这次事件显示出当监管有效时,可以规避潜在的风险。”

有效的药品生产质量管理和监管是为了预防问题和确保疫苗质量。但一旦发现问题,监管部门必须要采取行动。世卫组织赞扬中国国家药监局采取迅速而透明的行动,停止其生产并对事件展开调查。

世卫组织在2010年和2014年对中国国家药监部门进行过两次评估。结果显示国家药监部门达到了世卫组织充分行使职能的监管机构的标准,并明确承诺会继续改进。世卫组织欢迎中国国家药监局继续与世卫组织的加强国家监管部门的合作,这一合作已经开展了近20年。本次事件无疑令人遗憾,但此次事件由飞行检查发现,也说明了监管机构的体系监管和现场检查能有效保护人民健康。

世卫组织重申质量可靠的疫苗对于预防疾病至关重要,并鼓励各国继续采用这一具有成本效益性的公共卫生干预措施。中国的扩大免疫规划颇具成效,让中国实现了无脊髓灰质炎状态,并大幅减少了中国儿童中的麻疹、腮腺炎、风疹、甲肝和乙肝等疫苗可预防疾病。为此,世卫组织还对中国的疫苗生产商提供支持,使其达到国际标准和世卫组织预认证的要求。

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