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世界卫生组织对于中国狂犬病疫苗事件的媒体申明_海内新闻_消息_
2018-08-05 23:37
来源:未知
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世界卫生组织(世卫组织)完整支持中国国家药品监视管理局(中国国家药监局)扣留问题批次狂犬病疫苗、使其不能进入市场的行动。

有效的药品生产质量治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,监管部门必需要采用举动。世卫组织赞赏中国国家药监局采取敏捷而透明的行为,停滞其生产并对事件开展调查。

世界卫生组织驻华代表

国家药监局在对位于中国吉林省的疫苗生产厂家——长春永生生物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出产进程中存在记载造假的问题。政府已经扣留了所有涉事疫苗,防止给患者应用问题疫苗,并结束了该公司的疫苗生产。世卫组织正在等候进一步的考察结果,并随时筹备向中国国家卫生主管部门供给支撑。

高力博士

WHO STATEMENT ON RABIES VACCINE INCIDENT IN CHINA

Good manufacturing and regulatory practices are designed to prevent problems in the process of ensuring quality vaccines. But when problems are found, the regulator must take action. WHO commends the quick and transparent actions taken by China NDA to suspend production at the company and investigate these incidents。

“Regulatory oversight of vaccines is critically important. It is the government's primary method of ensuring that the vaccines produced and used in China are safe, of good quality and effective,” said Gauden Galea, WHO Representative for China. “This incident shows that when regulatory oversight works well, potential risks can be averted。”

世卫组织重申品质牢靠的疫苗对防备疾病至关主要,并激励各国继续采取这一存在本钱效益性的公共卫生干涉办法。中国的扩展免疫计划颇具功效,让中国实现了无脊髓灰质炎状况,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请求。

世卫组织在2010年和2014年对中国国家药监部分进行过两次评估。成果显示国家药监部门到达了世卫组织充足行使职能的监管机构的尺度,并明白许诺会继承改良。世卫组织欢送中国国度药监局持续与世卫组织的增强国家监管部门的协作,这一配合已经发展了近20年。本次事件无疑令人遗憾,但此次事件由飞翔检讨发明,也阐明了监管机构的系统监管和现场检查能有效维护国民健康。

WHO assessed the national regulatory authorities in 2010 and 2014, and found that they met WHO criteria as a functional regulator for vaccines with a clear commitment to continual improvement. WHO welcomes the fact that China's NDA continues to work with WHO's Regulatory Systems Strengthening program, as it has been doing for nearly 20 years. While the current incident is clearly regrettable, the detection of this event by an unannounced inspection shows that the regulatory authority’s system of checks and balances to protect population health is working。

WHO reiterates that quality-assured vaccines are critical for disease prevention and urges countries to continue using this cost-effective public health intervention. The Expanded Program on Immunization in China has brought results. It has made China free from polio and significantly reduced vaccine-preventable diseases such as measles, mumps, rubella, and hepatitis A and B among children. To that end, WHO is also supporting vaccine manufacturers in China to ensure that they comply with international standards and meet WHO Prequalification expectations。

The World Health Organization (WHO) fully supports China’s National Drug Administration’s (NDA’s) actions to withhold the problematic batches of rabies vaccine and ensure they are not placed on the market,陕西展位亮相文博会1号馆 “长安画派”作

During an unannounced inspection at the manufacturing site of Changchun Changsheng Life Sciences Ltd., a vaccine manufacturer in China’s northeastern Jilin province, the NDA discovered problems of data integrity in the production of the batches of rabies vaccine. Authorities have withheld all vaccines involved, to prevent their reaching patients, and suspended production at the company. WHO awaits the results of further investigations and stands ready to provide support to national health authorities。


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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保险、优质和有效的重要手腕。这次事件显示出当监管有效时,能够躲避潜在的危险。

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