天下卫生构造关于中国狂犬病疫苗事情的媒体声明_金牌官网
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天下卫生构造关于中国狂犬病疫苗事情的媒体声明

工夫:2018-07-26 04:38阅读:

  天下卫生构造(世卫构造)完全支持中国国度药品监视办理局(中国国度药监局)拘留题目批次狂犬病疫苗、使其不克不及进入市场的举动。

  国度药监局在对位于中国吉林省的疫苗消费厂家——长春永生生物科技株式会社的消费园地停止飞行反省时,查出该公司在涉事批次狂犬病疫苗消费进程中存在记载造假的题目。当局曾经拘留了一切涉事疫苗,防止给患者运用题目疫苗,并中止了该公司的疫苗消费。世卫构造正在等候进一步的观察后果,并随时预备向中国国度卫生主管部分提供支持。

  高力博士

  天下卫生构造驻华代表

  疫苗的羁系极端紧张,它是当局确保中国消费和运用的疫苗平安、优质和无效的次要手腕。这次事情表现出当羁系无效时,可以躲避潜伏的危害。

  无效的药品消费质量办理和羁系是为了防备题目和确保疫苗质量。但一旦发明题目,羁系部分必需要接纳举动。世卫构造歌颂中国国度药监局接纳敏捷而通明的举动,中止其消费并对事情睁开观察。

  世卫构造在2010年和2014年对中国国度药监部分停止过两次评价。后果表现国度药监部分到达了世卫构造充沛利用职能的羁系机构的规范,并明白答应会持续改良。世卫构造欢送中国国度药监局持续与世卫构造的增强国度羁系部分的合作,这一合作曾经展开了近20年。本次事情无疑令人遗憾,但这次事情由飞行反省发明,也阐明了羁系机构的体系羁系和现场反省能无效维护人民安康。

  世卫构造重申质量牢靠的疫苗关于防备疾病至关紧张,并鼓舞列国持续接纳这一具有本钱效益性的大众卫生干涉步伐。中国的扩展免疫计划颇具结果,让中国完成了无脊髓灰质炎形态,并大幅增加了中国儿童中的麻疹、腮腺炎、风疹、甲肝和乙肝等疫苗可防备疾病。为此,世卫构造还对中国的疫苗消费商提供支持,使其到达国际规范和世卫构造预认证的要求

  WHO STATEMENT ON RABIES VACCINE INCIDENT IN CHINA

  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.

  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.

  “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.”

  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.

  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.

  

编辑:钟梦哲

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