【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2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] verifies that the product is programmatically suitable for national immunization programmes in developing countries verifies that it meets the programmatic needs and is safe and effective for the population in developed countries other ii.vaccine portfolio please fill out the following table
ⅲ. managerial， administrative， commercial and regulatory infrastructure q1： does your pricing policy cover the full cost of each vaccine produced? no yes q2： does the company have a business plan? no yes q3： if the answer to the previous question is yes what is the period covered by the plan one year two years three or more years q4： does the company have a mechanism to conduct research on future demand in terms of types and quantity of products required in the market? no yes q5： does the company have control to hire and fire staff as necessary no yes q6： does the company have control over revenues? no yes q7： does the company have control to set salary policy? no yes q8： does the company have a regulatory affairs department? no yes q9： if the answer to the previous question is yes， what is the role of the regulatory affairs department briefly explain： q10： does the company have a commercial department? no yes q11： if the answer to the previous question is yes， what is the role of the commercial department? briefly explain： iv. quality systems including gmp/qa q1： does the company have a maintenance programme in place with allocated budget? no yes q2： does the company have a master validation plan? no yes q3： does the company have an established quality assurance unit? no yes q4： if the answer to the previous question is yes， what is the role of the qa unit? briefly explain： q5： is the company inspected for gmp compliance by nras from foreign countries? no yes q6： it the answer to the previous question is yes， please provide the names of the countries that inspected your company in the last 5 years. q7： does the company have a vaccine quality complaints department? no yes q8. please list in which aspects of gmp you consider your company requires additional training process validation documentation control equipment validation environmental monitoring method validation change control other v. nonclinical studies q1： has your company ever sponsored/conducted nonclinical studies? no yes q2： if yes， where were these studies conducted? （more than one answer allowed） company's own facility contractor's facility （e.g. university； contract research organization [cro] otherspecify：_______________________________________________ vi. clinical trials q1： has your company ever sponsored at least one phase i clinical trial? no yes q2： has your company ever sponsored at least one phase ii clinical trial? no yes q3： has your company ever sponsored at least one phase ⅲ clinical trial? no yes q4： does your company? （more than one answer allowed） conduct its own clinical trials has its clinical trials conducted by a government institution （e.g. cdc） hires a contract research organization [cro] to do that has done both not applicable q5： previously to being conducted the clinical trials sponsored by your company require： （more than one answer allowed） approval by local ethics committees （of the institutions/hospitals were the trials are going to be conducted） approval by a regional or federal ethics committee approval by sfda q6： when the clinical trials sponsored by your company are approved does your company or the principal investigator receive an approval letter or an equivalent document? from each local ethics committee （of the institutions/hospitals where the trials are going to be conducted） from a regional or federal ethics committee from the sfda no document is received q7： in the clinical trials sponsored by your company have you ever had a data and safety monitoring board? no yes not applicable q8： to whom are the adverse events observed in the clinical trials sponsored by your company reported 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 q9： have any of the clinical trials sponsored by your company ever been submitted to a good clinical practices （gcp） inspection： （more than one answer allowed） | |||||||||||||||||||||||||||||||||||||||||||||||||||
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