摘要
疫苗生产安全事故给疫苗接种带来了严重的信任危机,为此,《疫苗管理法》对疫苗生产安全作出新的规定。从疫苗生产环节入手,将《疫苗管理法》中有关生产环节的规定与《药品管理法》《药品管理法实施条例》《药品生产质量管理规范》《药品生产监督管理办法》中关于生产环节的规定予以比较,并分析新法的进步性,提出完善《疫苗管理法》关于生产环节的建议:进一步完备疫苗生产准入制度细则,完善疫苗上市许可持有人制度,明晰支持疫苗产业发展的法律规定,明确疫苗生产监管责任。
The safety accidents of vaccine production have caused a serious crisis of confidence in vaccination.Therefore,Vaccine Administration Law has made some new provisions on the safety of vaccine production.Comparing the provisions about vaccine production in Vaccine Administration Law with those in other relevant laws,such as Pharmaceutical Administration Law,Regulations for the Implementation of the Drug Administration Law,Good Manufacturing Practice,Measures for Supervision and Administration of Drug Production,it points out the advance of the new law and puts forward some suggestions that can further improve the new law:it is necessary to complete the details of the access system of vaccine production,improve the system of vaccine marketing license holders,clarify the legal provisions supporting the development of the vaccine industry,and clarify the regulatory responsibilities for vaccine production.
作者
张林琳
范阳东
ZHANG Lin-lin;FAN Yang-dong(School of Health Management,Guangzhou Medical University,Guangzhou,Guangdong,511436,China;不详)
出处
《中国初级卫生保健》
2021年第4期7-9,共3页
Chinese Primary Health Care
关键词
疫苗安全
疫苗生产
《疫苗管理法》
vaccine safety
vaccine production
Vaccine Administration Law of PRC
