发布部门: 国家食品药品监督管理局
发布文号: 食药监安便函[2011]12号
北京、河北、辽宁、吉林、上海、江苏、浙江、广东、河南、湖北、四川、云南、甘肃等省（市）食品药品监督管理局（药品监督管理局）：
中国疫苗监管体系已通过世界卫生组织的正式评估。为推动我国疫苗生产企业申请世界卫生组织预认证并积极参与国际疫苗招标采购，实施“走出去”战略，国家局将在京举办世界卫生组织疫苗预认证申报程序培训班，并召开疫苗生产企业座谈会。现将有关事项通知如下：
一、会议主要内容
（一）世界卫生组织专家讲解世界卫生组织预认证申报程序及相关要求；
（二）动员疫苗生产企业积极参与世界卫生组织疫苗预认证工作；
（三）通报《药品生产质量管理规范（2010年修订）》修订情况和实施要求。
二、参会人员
各辖区有疫苗生产企业的省（市）食品药品监督管理局负责疫苗生产监管工作的同志1人；各疫苗生产企业（企业名单见附件1）负责人及有关人员各1人。中国食品药品检定研究院、国家局药品认证管理中心人员自定。
三、会议时间及地点
2011年3月1-2日，2月28日报到，会期一天半。会议地点：西藏大厦b座10层大宴会厅（北京市朝阳区北四环东路118号，电话：010-64981133）
四、其他事项
1、参会的有关省（市）食品药品监督管理局会议代表食宿费用由国家局负责；疫苗生产企业会议代表交通及食宿费用自理。
2、请各省局负责通知辖区内各疫苗生产企业参加会议。同时，为做好疫苗预认证申报程序的培训，请各企业填写世界卫生组织专家调查问卷（见附件2），并携带至培训会场。调查问卷请登陆国家局网站（www.sfda.gov.cn）本通知页面自行下载。
3、会务工作委托中国生物技术集团公司负责。请各参会单位填写回执（见附件3），及时传真至中国生物技术集团公司。
联系人：中国生物技术集团公司 王芙
电话：010-84663069
传真：010-84663322
国家局药品安全监管司 崔野宋，刘景起
电话：010-88330850，88330864
附件1：参加会议的疫苗生产企业名单
附件2：世界卫生组织专家调查问卷表
附件3：参会回执
国家食品药品监督管理局药品安全监管司
二〇一一年二月二十四日
附件1：
参加会议的疫苗生产企业名单
附件2：
世界卫生组织专家调查问卷表
general information questionnaire
please take some time to answer the following questionnaire， which is aimed at getting general information on the profile of your company. your responses will help who to understand where chinese vaccine manufacturers stand in relation to vaccine production， quality policy and general managerial and commercial approaches in place. the filled questionnaires will be collected by who staff during the meeting to be held on 1st march 2011
i. general understanding of the pq procedure
q1： is your company aware of the existence of the who vaccines' prequalification program
no
yes
q2： do you know how to submit an application of a vaccine produced by your company to who for prequalification evaluation?
no
yes
list the steps of which you are aware：
q3： what is the purpose of the who vaccines prequalification procedure?
（more than one answer allowed）
advise countries on the quality of vaccine
a service to united nations purchasing agencies
advice to united nations purchasing agencies on the quality， safety and efficacy of vaccines for purchase
ensure compliance with who requirements and un tender specifications
monitor the quality of vaccines purchased through un agencies
other
q4： what are the principles of the prequalification procedure （more than one answer allowed）
ethical
commercial
reliance on nras
compliance with gmp
product safe and effective for target population
consistent quality
product meets who requirements and tender specifications
other
q5： what is the added value of the prequalification procedure （more than one answer allowed）
replicates the work of the producing country nra
verifies that the product is safe and effective for the target population in receiving
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）
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
发布文号: 食药监安便函[2011]12号
北京、河北、辽宁、吉林、上海、江苏、浙江、广东、河南、湖北、四川、云南、甘肃等省（市）食品药品监督管理局（药品监督管理局）：
中国疫苗监管体系已通过世界卫生组织的正式评估。为推动我国疫苗生产企业申请世界卫生组织预认证并积极参与国际疫苗招标采购，实施“走出去”战略，国家局将在京举办世界卫生组织疫苗预认证申报程序培训班，并召开疫苗生产企业座谈会。现将有关事项通知如下：
一、会议主要内容
（一）世界卫生组织专家讲解世界卫生组织预认证申报程序及相关要求；
（二）动员疫苗生产企业积极参与世界卫生组织疫苗预认证工作；
（三）通报《药品生产质量管理规范（2010年修订）》修订情况和实施要求。
二、参会人员
各辖区有疫苗生产企业的省（市）食品药品监督管理局负责疫苗生产监管工作的同志1人；各疫苗生产企业（企业名单见附件1）负责人及有关人员各1人。中国食品药品检定研究院、国家局药品认证管理中心人员自定。
三、会议时间及地点
2011年3月1-2日，2月28日报到，会期一天半。会议地点：西藏大厦b座10层大宴会厅（北京市朝阳区北四环东路118号，电话：010-64981133）
四、其他事项
1、参会的有关省（市）食品药品监督管理局会议代表食宿费用由国家局负责；疫苗生产企业会议代表交通及食宿费用自理。
2、请各省局负责通知辖区内各疫苗生产企业参加会议。同时，为做好疫苗预认证申报程序的培训，请各企业填写世界卫生组织专家调查问卷（见附件2），并携带至培训会场。调查问卷请登陆国家局网站（www.sfda.gov.cn）本通知页面自行下载。
3、会务工作委托中国生物技术集团公司负责。请各参会单位填写回执（见附件3），及时传真至中国生物技术集团公司。
联系人：中国生物技术集团公司 王芙
电话：010-84663069
传真：010-84663322
国家局药品安全监管司 崔野宋，刘景起
电话：010-88330850，88330864
附件1：参加会议的疫苗生产企业名单
附件2：世界卫生组织专家调查问卷表
附件3：参会回执
国家食品药品监督管理局药品安全监管司
二〇一一年二月二十四日
附件1：
参加会议的疫苗生产企业名单
| 北京 | 北京华尔盾生物技术有限公司 |
| 北京科兴生物制品有限公司 | |
| 北京绿竹生物制药有限公司 | |
| 北京天坛生物制品股份有限公司 | |
| 河北 | 福尔生物制药股份有限公司 |
| 华北制药金坦生物技术股份有限公司 | |
| 吉林 | 长春百克生物科技有限公司 |
| 长春长生生物科技股份有限公司 | |
| 长春祈健生物制品有限公司 | |
| 长春生物制品研究所 | |
| 吉林迈丰生物药业有限公司 | |
| 吉林亚泰生物药业股份有限公司 | |
| 辽宁 | 大连汉信生物制药有限公司 |
| 大连雅立峰生物制药有限公司 | |
| 辽宁成大生物股份有限公司 | |
| 辽宁依生生物制药有限公司 | |
| 上海 | 上海联合赛而生物工程有限公司 |
| 上海生物制品研究所 | |
| 上海润泽生物科技有限公司 | |
| 江苏 | 江苏延申生物科技股份有限公司 |
| 罗益（无锡）生物制药有限公司 | |
| 浙江 | 宁波荣安生物药业有限公司 |
| 浙江普康生物技术股份有限公司 | |
| 浙江天元生物药业股份有限公司 | |
| 浙江卫信生物药业有限公司 | |
| 广东 | 广州诺城生物制品股份有限公司 |
| 深圳康泰生物制品股份有限公司 | |
| 深圳赛诺非巴斯德生物制品有限公司 | |
| 深圳市海王英特龙生物技术股份有限公司 | |
| 河南 | 河南普新生物工程有限公司 |
| 华兰生物疫苗有限公司 | |
| 湖北 | 武汉生物制品研究所 |
| 甘肃 | 兰州生物制品研究所 |
| 四川 | 成都生物制品研究所 |
| 云南 | 中国医学科学院医学生物学研究所 |
| 玉溪沃森生物技术有限公司 |
附件2：
世界卫生组织专家调查问卷表
general information questionnaire
please take some time to answer the following questionnaire， which is aimed at getting general information on the profile of your company. your responses will help who to understand where chinese vaccine manufacturers stand in relation to vaccine production， quality policy and general managerial and commercial approaches in place. the filled questionnaires will be collected by who staff during the meeting to be held on 1st march 2011
i. general understanding of the pq procedure
q1： is your company aware of the existence of the who vaccines' prequalification program
no
yes
q2： do you know how to submit an application of a vaccine produced by your company to who for prequalification evaluation?
no
yes
list the steps of which you are aware：
q3： what is the purpose of the who vaccines prequalification procedure?
（more than one answer allowed）
advise countries on the quality of vaccine
a service to united nations purchasing agencies
advice to united nations purchasing agencies on the quality， safety and efficacy of vaccines for purchase
ensure compliance with who requirements and un tender specifications
monitor the quality of vaccines purchased through un agencies
other
q4： what are the principles of the prequalification procedure （more than one answer allowed）
ethical
commercial
reliance on nras
compliance with gmp
product safe and effective for target population
consistent quality
product meets who requirements and tender specifications
other
q5： what is the added value of the prequalification procedure （more than one answer allowed）
replicates the work of the producing country nra
verifies that the product is safe and effective for the target population in receiving
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
| vaccine produced by your company | no. of lots produced per year | no. of doses per lot | total no. of doses produced in 2010 | country/ies where vaccine is licensed | supply | |
| domestic | international | |||||
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）
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
| 单位 | | ||||
| 姓名 | | 性别 | | 手机 | |
| 部门 | | 职务 | | ||
| 姓名 | | 性别 | | 手机 | |
| 部门 | | 职务 | | ||
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
