【法规名称】
【颁布部门】 国家食品药品监督管理局(原国家药品监督管理局)
【发文字号】 食药监安便函[2011]12号
【颁布时间】 2011-02-24
【实施时间】 2011-02-24
【效力属性】 有效
【法规编号】 545834 什么是编号？
【正 文】
第3页 国家食品药品监督管理局药品安全监管司关于举办世界卫生组织疫苗预认证申报程序培训班暨疫苗生产企业座谈会的通知
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[接上页] yes， from an ethics committee yes， from sfda no not applicable q10： once a clinical trial sponsored by your company is approved does your company have to send periodic （e.g. annual） reports about the trial to： （more than one answer allowed） local ethics committee （of the institutions/hospitals were the trials are going to be conducted） regional or federal ethics committee sfda none not applicable q11： to be able to conduct a clinical trial has your company ever needed to import from a foreign country a vaccine or drug to be used as a comparator （in the control group） no yes q12： when your company needs to design a clinical trial who is responsible for that? （more than one answer allowed） staff from your own company my company outsources the work （to a consultant， a contract research organization， or other） other specify： __________________________________________ q13： are the clinical trials sponsored by your company registered in a clinical trial registry? no yes， sometimes yes， always not applicable q14： when your company performs clinical trials， who performs the immunogenicity test own laboratory specialized laboratories contracted for the purpose depending on type of test in house or outsourced not applicable vii. post-marketing surveillance q1： does your company have a department of pharmacovigilance? no yes q2： does the pharmacovigilance department of your company employ at least? （more than one answer allowed） one physician （medical doctor） one pharmacist not applicable q3： how does your company collect information on adverse events following immunization （aefis） observed with its vaccines after they are registered/licensed/marketed? （more than one answer allowed） spontaneous reports by physicians spontaneous reports by other health professionals active surveillance phase iv clinical trials none not applicable q4： does your company prepare periodic safety update reports （psurs） of its products? no yes q5： is the presentation of a pharmacovigilance plan currently a requirement for the registration/licensure/marketing authorization of vaccines in china? no yes 附件3： 世界卫生组织疫苗预认证申报程序培训班暨 疫苗生产企业座谈会参会回执
回执传真：010-84663322，电话：010-84663069 联系人：中国生物技术集团公司 王芙 | ||||||||||||||||||||||||||||||
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