2019年6月29日,十三届全国人大常委会第十一次会议举行了闭幕会,经由三次审议的《疫苗管理法》在本次会议上得以通过。《疫苗管理法》对疫苗实施了全过程的严管,对生产销售假劣疫苗的,设置严厉处罚。
China's top legislature passed a law on vaccine administration, which stipulates strict management by requiring a whole-process supervision system and toughening penalties on producing and selling fake or substandard vaccines. The law was adopted after the third reading at a bimonthly session of the Standing Committee of the National People's Congress, which closed on June 29.
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。
It is a bounden responsibility for Party committees and governments at all levels to ensure drug safety. The people's health should always be a top priority and the bottom line of safety should be resolutely guarded. A firm determination should be mustered to improve the country's vaccine management system, and utmost efforts should be made to protect the people's interests and social security and stability.
——2018年7月23日,习近平对吉林长春长生生物疫苗案件作出重要指示
《疫苗管理法》坚持以“最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责”的“四个最严”为立法宗旨,规定构成违法犯罪依法从重追究刑事责任,罚款进一步提高,如生产、销售的疫苗属于假药的,最高罚款从相应货值金额30倍增加至50倍,属于劣药的,最高罚款从20倍增加至30倍。针对有严重违法行为的责任人员,也增加规定了行政拘留等惩罚。作为强化疫苗全程质量监管的一个最有效措施,《疫苗管理法》规定了国家实行疫苗全程电子追溯制度,由国务院的药品监督管理部门会同国务院的卫生健康部门,制定统一的疫苗的追溯标准,还有相应的规范。建立全国疫苗信息化追溯的协同平台,整合疫苗生产、流通、预防接种相关信息,最终实现疫苗全程电子的可追溯。
- 全过程监管
whole-process supervision - 食品药品安全
food and drug safety - 电子追溯制度
electronic tracking system