疫苗事件 vaccine case

　　近日，长春长生生物科技有限公司“狂犬病疫苗生产记录造假”及“百白破疫苗效价不符合规定”两起事件备受关注。

　　在国外访问的中共中央总书记、国家主席、中央军委主席习近平对吉林长春长生生物疫苗案件作出重要指示指出，长春长生生物科技有限责任公司违法违规生产疫苗行为，性质恶劣，令人触目惊心(hideous and appalling)。

　　Relevant departments and local authorities should pay close attention and immediately probe the case to find the truth, Xi said, adding that the investigation should be thorough, the punishment severe, the accountability held seriously, and the case's progress should be publicized on time to address public concern.

　　有关地方和部门要高度重视，立即调查事实真相，一查到底，严肃问责，依法从严处理。要及时公布调查进展，切实回应群众关切。

　　习近平强调，

　　It is a bounden responsibility for Party committees and governments at all levels to ensure drug safety and the people's health should always be a top priority. A firm determination should be mustered to improve the country's vaccine management system, resolutely guard the bottom line of safety, and utmost efforts should be made to protect the people's interests and social security and stability.

　　确保药品安全是各级党委和政府义不容辞之责，要始终把人民群众的身体健康放在首位，以猛药去疴、刮骨疗毒的决心，完善我国疫苗管理体制，坚决守住安全底线，全力保障群众切身利益和社会安全稳定大局。

　　此前，李克强总理就疫苗事件作出批示：

　　The vaccine case has crossed a moral line, and the nation deserves a clear explanation.

　　此次疫苗事件突破人的道德底线，必须给全国人民一个明明白白的交代。

　　李克强在批示中要求，

　　The State Council should immediately send a group to thoroughly investigate the production and selling chain of vaccine, to uncover the truth as soon as possible, and any wrongdoing will be severely punished regardless of who is involved.

　　国务院要立刻派出调查组，对所有疫苗生产、销售等全流程全链条进行彻查，尽快查清事实真相，不论涉及到哪些企业、哪些人都坚决严惩不贷、绝不姑息。

　　Any illegal acts that could harm the people's lives should be severely cracked down and people behind it punished in accordance with law. Any dereliction of duty in the supervision authority should be held accountable, and we should give the people a living environment that is safe, trustworthy and credible.

　　对一切危害人民生命安全的违法犯罪行为坚决重拳打击，对不法分子坚决依法严惩，对监管失职渎职行为坚决严厉问责。尽早还人民群众一个安全、放心、可信任的生活环境。

　　针对“狂犬病疫苗生产记录造假”事件，昨日，国家药监局在官网通报最新调查进展。

　　According to the investigation, the company counterfeited the vaccine’s production and inspection data, and changed the parameters for equipment and processing the vaccine.

　　通报说，现已查明，企业编造生产记录和产品检验记录，随意变更工艺参数和设备。

　　目前，已责令企业停止生产(terminate the production)，收回药品生产质量管理规范(Good Manufacturing Practices，GMP)证书，同时会同吉林省局已对企业立案调查，涉嫌犯罪的移送公安机关追究刑事责任(the cases of those suspected of violating laws will be transferred to public security departments)。

　　GMP(Good Manufacturing Practices)，中文含义是“生产质量管理规范”或“良好作业规范”、“优良制造标准”。

　　Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

　　“良好作业规范”是监管部门审批和发放食品饮料、化妆品、药品、膳食补充剂以及医疗设备时要遵照的规范要求。

　　These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.

　　这些规范是生产方确保所有批次产品保证高质量并且有效的基本要求，每个行业的具体规范或有不同，但GMP的核心目标是防止产品对终端用户产生有害影响。

　　国家药监局表示，已部署全国疫苗生产企业进行自查，确保企业按批准的工艺组织生产，严格遵守GMP生产规范，所有生产检验过程数据要真实、完整、可靠，可以追溯。

　　国家药监局将组织对所有疫苗生产企业进行飞行检查(unannounced inspections)，对违反法律法规规定的行为要严肃查处。

　　根据习近平指示和李克强要求，国务院已建立专门工作机制(establish a task-force)，并派出调查组进驻长春长生生物科技有限责任公司进行立案调查。吉林省成立省市两级案件查处领导小组，配合国务院调查组做好相关工作，并结合此案件全面排查高风险药品企业(look into all other high-risk pharmaceutical companies)。

　　目前，长春长生董事长高某芳等15名涉案人员已被长春新区公安分局依法刑事拘留(criminal detention);吉林、山东两省纪委监委启动对长春长生疫苗案可能存在的腐败问题展开调查(conduct inspections regarding any possible corruption problems)。

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