中国药科大学 梁 毅 王 莉
欧盟是一个集政治实体和经济实体于一身、在世界上具有重要影响的区域一体化组织。欧盟的各种立法共有8万页之多，GMP规范只是沧海一粟，它是欧盟成员国所有制药企业必须遵循的法定规范，但各个成员国也可以根据本国具体情况，制定标准高于欧盟GMP的规范。 欧盟药事管理法规概况
欧盟(EU)自1965年以来，为实现保护公众健康、建立药品自由流通的统一大市场这两个目标，制定、颁布并实施了一系列药事管理法规及指导性文件。根据这些法规文件的效力可分为三个层面。
第一层面是法规(Regulations)和法令(Directives)。它们是由欧洲委员会(EC)、欧洲议会及成员国部长委员会制定、通过的。这里的法规具有法律效力，一旦颁布，各成员国必须遵循；法令在颁布数年后，也将陆续纳入各国法律。法令性文件是欧盟药事管理法规的主体，集中体现了欧盟对药品管理的主要原则和要求，是欧盟构建统一药事法规的基本法律框架，各成员国需要通过立法将其转化为国内法实施。
法令依其内容又可分为四种类型：①基本型(Basic)，主要有三个文件组成，这些文件明确了药品的定义，并规定：专卖药品上市须经成员国药政当
evelopment work steadily in the pilot counties, to build peace neighborhood offices approved, \"change\ban and rural communities (Center), immigrant communities, pilot projects such as integrated management of urban and rural sanitation in order. (D) maintain social harmony and stability. In the case of tight financial situation, continue to increase the input of people, happy people battle. Urban central heating and upgrade rural power grids, rural reconstruction of shabby housing ten major projects being delivered, has been overfulfilled ahead. Strengthening of social programs, college entrance examination to record heights; new rural insurance coverage rate of the city's first, launched in new rural cooperative medical clinic co-ordination; ... Perfect Park catering, accommodation, education, recreation and other tertiary industries supporting, improving socialization service level, for industries, businesses and create a good environment for development. 3, flexible investment, enhancethe industry. Construction of industrial parks, just set up a platform for the development of only attract more projects into the district, to form agglomeration advantages. A innovation project. To be purposeful, targeted investment, will have a basis of the County's industrial packaged bundles, overall publicity and promotion. Initiative going, please come in and carry out all-round, multi-level and wide-range of investment activities. The Township industrial projects, in principle, to put to the West industrial parks. What town project, is that the output value of the Township. Second, we must grasp the standards selected items. Full account of extend the industry chain and the integration of factors of production, not only efforts to introduce a number of scientific and technological content and high added value, growth and strong driving force of large projects and large enterprises, but also on domestic-funded enterprises and in accordance with the direction of industrial development of small and medium projects, project man, small project overwhelming. Meet the area of the County's new industrial projects and city back into rural enterprises, in principle, all stationed in industrial parks. Meanwhile, strict control of excess capacity and high energy consumption, high emission enterprises to enter. Thirdly, increased incentives on the project. Investment of the whole society, the ownship and County units go out and draft project. o establish investment incentives for successful introduction of significant project gives awards to units and individuals, the introduction of tax for the implementation of the project, to introduce organization into rewards. 4, preferential policies, and security industries. In terms of project examination and approval, by area Admnistrative Committee in conjunction with the development, planning, land, industry and commerce, quality control and other departments, \"one-stop reception, one-stop service\he simplified procedures, the time limit originally. In the management of EIA in accordance with theBuilding industry opens up new world of entrepreneurial struggle to build a three provinces of regional central cities--in the Communist x counties the six plenary session members and comrades: today, I was commissioned by the County party Committee Standing Committee, reports to the General Assembly. Consideration of all members and alternates, and comrades attending advice. A, and this year yilai of work recalled this year yilai, in municipal of right led Xia, County solidarity led County people, to science development views for guide, to good activities for mainline, according to \"a city four modernizations three more\" of development thought, concentrated poly force, work hard, political, and economic, and culture, and social and party of construction are made has new progress, County rendering out wind fresh are, and career prosperity, and social settled, and people mind into of good situation. (A) facilitating the construction of the project. Firmly establish the \"scratch project is economic, grasping development project is to hold\" philosophy, to extraordinary efforts to promoting the construction of key projects. Plot 108 key projects for the year, with a total investment of 29.3 billion yuan, iron plate, Josh stone cement waste heat power generation and 13 projects completed, worship of 1.2 million tons of pellets, Hua Yu 80,000 sets of grandparent chicken farming, 47 projects under construction, completed investment of 3.95 billion yuan, annual plan of 69.3%. The first half of the County's gross domestic product is expected to reached 8.5 billion yuan, and total revenue of 943 million Yuan. (B) structural adjustment achieved remarkable results. Actively transforming the pattern of economic development, industrial ecology, and agricultural modernization and industrialization of services. High x-County • Tin iron circular economy demonstration area, and further expand economic development zone Jing Dian recycle economy ecology industry Park, Park, circulareconomy and rapid economic development. Focus more on the dialectical relationship between development and environmental protection, energy saving and emission reduction projects play an important role. Vigorously developing agriculture, ecological agriculture, agriculture, modern agricultural clearing along the River Promenade begins to take shape. Key tourism projects is going well, WA Palace area was named \"top ten most influential cultural relics in Hebei province landscape\". Develop new services, and services with new developments. (C) urban-rural integration process. Promoting \"three-year difference\" campaign, battle of two large demolition completed 32 days of 530,000 square meters, exceeded the annual ask 7 months in advance. General big building jiangjun road, bridge and highway bridges, the green heart of the city and other urban construction projects, and focus on building new countryside and new housing model villages, urban and rural areas improve. Highwayopened to traffic, Liu Zhang, Qing LAN high-speed x-County section completed by the end of August. Urban and rural局批准，即药政当局有权批准拒绝上市申请、中止或撤销上市许可，有权检查生产和复检试验结果。当局的审批时间为300天。上市许可的有效期为5年，并需每5年重新申报、审批。申报者必须详细提供药学、药理毒理和临床的研究资料及专家报告。专家报告是由上述三领域的专家分别对各自领域的研究资料及结果作出总结和评述。此外，申报者应指定一名有资格者负责确保实际生产与申报资料的一致性。②修订型(Amending)，是根据上述基础性法规在执行中出现的问题，对有关内容予以进一步的阐述和修订。③扩展型(Extend)，是对化学药品以外的其他类型药品(如免疫制品、放射性制品、人血及血清制品、顺势疗法药品等)做进一步的规定。④其他，即关于药品标签和说明书的等内容规定。
第二层面是指由欧盟委员会依据有关法令和法规而颁布实施的药品注册监督管理程序和GMP指南。
第三层面是指由欧洲药品评价局(EMEA)颁布实施的一些技术指南，以及对一些法规条款所做的解释。
摘自《中国医药报》
欧盟GMP法规制度简介(二)
中国药科大学 梁 毅 王 莉
欧盟药品审评机构及程序
evelopment work steadily in the pilot counties, to build peace neighborhood offices approved, \"change\ban and rural communities (Center), immigrant communities, pilot projects such as integrated management of urban and rural sanitation in order. (D) maintain social harmony and stability. In the case of tight financial situation, continue to increase the input of people, happy people battle. Urban central heating and upgrade rural power grids, rural reconstruction of shabby housing ten major projects being delivered, has been overfulfilled ahead. Strengthening of social programs, college entrance examination to record heights; new rural insurance coverage rate of the city's first, launched in new rural cooperative medical clinic co-ordination; ... Perfect Park catering, accommodation, education, recreation and other tertiary industries supporting, improving socialization service level, for industries, businesses and create a good environment for development. 3, flexible investment, enhancethe industry. Construction of industrial parks, just set up a platform for the development of only attract more projects into the district, to form agglomeration advantages. A innovation project. To be purposeful, targeted investment, will have a basis of the County's industrial packaged bundles, overall publicity and promotion. Initiative going, please come in and carry out all-round, multi-level and wide-range of investment activities. The Township industrial projects, in principle, to put to the West industrial parks. What town project, is that the output value of the Township. Second, we must grasp the standards selected items. Full account of extend the industry chain and the integration of factors of production, not only efforts to introduce a number of scientific and technological content and high added value, growth and strong driving force of large projects and large enterprises, but also on domestic-funded enterprises and in accordance with the direction of industrial development of small and medium projects, project man, small project overwhelming. Meet the area of the County's new industrial projects and city back into rural enterprises, in principle, all stationed in industrial parks. Meanwhile, strict control of excess capacity and high energy consumption, high emission enterprises to enter. Thirdly, increased incentives on the project. Investment of the whole society, the ownship and County units go out and draft project. o establish investment incentives for successful introduction of significant project gives awards to units and individuals, the introduction of tax for the implementation of the project, to introduce organization into rewards. 4, preferential policies, and security industries. In terms of project examination and approval, by area Administrative Committee in conjunction with the development, planning, land, industry and commerce, quality control and other departments, \"one-stop reception, one-stop service\he simplified procedures, the time limit originally. In the management of EIA in accordance with theBuilding industry opens up new world of entrepreneurial struggle to build a three provinces of regional central cities--in the Communist x counties the six plenary session members and comrades: today, I was commissioned by the County party Committee Standing Committee, reports to the General Assembly. Consideration of all members and alternates, and comrades attending advice. A, and this year yilai of work recalled this year yilai, in municipal of right led Xia, County solidarity led County people, to science development views for guide, to good activities for mainline, according to \"a city four modernizations three more\" of development thought, concentrated poly force, work hard, political, and economic, and culture, and social and party of construction are made has new progress, County rendering out wind fresh are, and career prosperity, and social settled, and people mind into of good situation. (A) facilitating the construction of the project. Firmly establish the \"scratch project is economic, grasping development project is to hold\" philosophy, to extraordinary efforts to promoting the construction of key projects. Plot 108 key projects for the year, with a total investment of 29.3 billion yuan, iron plate, Josh stone cement waste heat power generation and 13 projects completed, worship of 1.2 million tons of pellets, Hua Yu 80,000 sets of grandparent chicken farming, 47 projects under construction, completed investmnt of 3.95 billion yuan, annual plan of 69.3%. The first half of the County's gross domestic product is expected to reached 8.5 billion yuan, and total revenue of 943 million Yuan. (B) structural adjustment achieved remarkable results. Actively transforming the pattern of economic development, industrial ecology, and agricultural modernization and industrialization of services. High x-County • Tin iron circular economy demonstration area, and further expand economic development zone Jing Dian recycle economy ecology industry Park, Park, circulareconomy and rapid economic development. Focus more on the dialectical relationship between development and environmental protection, energy saving and emission reduction projects play an important role. Vigorously developing agriculture, ecological agriculture, agriculture, modern agricultural clearing along the River Promenade begins to take shape. Key tourism projects is going well, WA Palace area was named \"top ten most influential cultural relics in Hebei province landscape\". Develop new services, and services with new developments. (C) urban-rural integration process. Promoting \"three-year difference\" campaign, battle of two large demolition completed 32 days of 530,000 square meters, exceeded the annual ask 7 months in advance. General big building jiangjun road, bridge and highway bridges, the green heart of the city and other urban construction projects, and focus on building new countryside and new housing model villages, urban and rural areas improve. Highwayopened to traffic, Liu Zhang, Qing LAN high-speed x-County section completed by the end of August. Urban and rural 一、 欧盟药品监管机构简介
欧盟药品监管机构，即欧洲药品管理局(European Medicines Agency，简称EMA)，其前身(2004年前)为欧洲药品评价局
(European Agency for the Evaluation of Medical Products，简称EMEA)，于1993年依法成立，自1995年开始正式受理欧盟各成员国人用和兽用专卖药品的上市申请。该局办事机构在伦敦，其主要任务是负责对申请上市的新药进行技术审评和监督管理，具体有以下六方面：1.向成员国当局和欧洲委员会提供人用药品和兽用药品在质量、安全、疗效方面的科学意见；2.动员各成员国现有的力量，组建一支多国性专家队伍，以实现对申请上市许可的新药申报资料实行一次性审评；3.在欧盟内为药品审批、监督(或药品的撤销)建立一整套快速、高效、高透明度的工作程序；4.加强对上市药品的监督，协调各成员国的药品警惕工作和GMP、GCP、GLP的监督工作；5.为制药公司提供法规和科学技术方面的咨询服务；6.建立必要的数据库和现代视听通讯设备，促进药品审评监督及管理的情报信息工作。
欧盟各成员国有各自的药品监管机构，行政上与EMA虽无联系，但承担了所在国药品审批互认程序和分散程序、EMA委派的监督检查和所在国的日常监督检查、所在国药品上市后疗效与安全性监控等工作。 二、欧盟对药品上市申请的审批程序
欧盟药品上市审批程序可概括为“两层机构、三种程序”，即欧盟和各成员国的药品管理局两层机构；欧盟的集中申请程序，多个成员国之间共识认可的非集中申请程序和在一个成员国申请上市的一国申请程序。其中，EMEA执行“集中程序”；成员国当局执行“非集中程序”和“一国程序”。在非集中程序过程中，如果成员国之间出现意见分歧时，由EMEA负责予以仲裁。 集中程序是一种统一、简捷的审批程序。遵循这一程序，一个新药产品
evelopment work steadily in the pilot counties, to build peace neighborhood offices approved, \"change\ban and rural communities (Center), immigrant communities, pilot projects such as integrated management of urban and rural sanitaton in order. (D) maintain social harmony and stability. In the case of tight financial situation, continue to increase the input of people, happy people battle. Urban central heating and upgrade rural power grids, rural reconstruction of shabby housing ten major projects being delivered, has been overfulfilled ahead. Strengthening of social programs, college entrance examination to record heights; new rural insurance coverage rate of the city's first, launched in new rural cooperative medical clinic co-ordination; ... Perfect Park catering, accommodation, education, recreation and other tertiary industries supporting, improving socialization service level, for industries, businesses and create a good environment for development. 3, flexible investment, enhancethe industry. Construction of industrial parks, just set up a platform for the development of only attract more projects into the district, to form agglomeration advantages. A innovation project. To be purposeful, targeted investment, will have a basis of the County's industrial packaged bundles, overall publicity and promotion. Initiative going, please come in and carry out all-round, multi-level and wide-range of investment activities. The Township industrial projects, in principle, to put to the West industrial parks. What town project, is that the output value of the Township. Second, we must grasp the standards selected items. Full account of extend the industry chain and the integration of factors of production, not only efforts to introduce a number of scientific and technological content and high added value, growth and strong driving force of large projects and large enterprises, but also on domestic-funded enterprises and in accordance with the direction of industrial development of small and medium projects, project man, small project overwhelming. Meet the area of the County's new industrial projects and city back into rural enterprises, in principle, all stationed in industrial parks. Meanwhile, strict control of excess capacity and high energy consumption, high emission enterprises to enter. Thirdly, increased incentives on the project. Investment of the whole society, the Township and County units go out and draft project. o establish investment incentives for successful introduction of significant project gives awards to units and individuals, the introduction of tax for the implementation of the project, to introduce organization into rewards. 4, preferential policies, and security industries. In terms of project examination and approval, by area Administrative Committee in conjunction with the development, planning, land, industry and commerce, quality control and other departments, \"one-stop reception, one-stop service\he simplified procedures, the time limit originally. In the management of EIA in accordance with theBuilding industry opens up new world of entrepreneurial struggle to build a three provinces of regional central cities--in the Communist x counties the six plenary session members and comrades: today, I was commissioned by the County party Committee Standing Committee, reports to the General Assembly. Consideration of all members and alternates, and comrades attending advice. A, and this year yilai of work recalled this year yilai, in municipal of right led Xia, County solidarity led County people, to science development views for guide, to good activities for mainline, according to \"a city four modernizations three more\" of development thought, concentrated poly force, work hard, political, and economic, and culture, and social and party of construction are made has new progress, County rendering out wind fresh are, and career prosperity, and social settled, and people mind into of good situation. (A) facilitating the construction of the project. Firmly establish the \"scratch project is economic, grasping development project is to hold\" philosophy, to extraordinary efforts to promoting the construction of key projects. Plot 108 key projects for the year, with a total investment of 29.3 billion yuan, iron plate, Josh stone cement waste heat power generation and 13 projects completed, worship of 1.2 million tons of pellets, Hua Yu 80,000 sets of grandparent chicken farming, 47 projects under construction, completed investment of 3.95 billion yuan, annual plan of 69.3%. The first half of the County's gross domestic product is expected to reached 8.5 billion yuan, and total revenue of 943 million Yuan. (B) structural adjustment achieved remarkable results. Actively transforming the pattern of economic development, industrial ecology, and agricultural modernization and industrialization of services. High x-County • Tin iron circular economy demonstration area, and further expand economic development zone Jing Dian recycle economy ecology industry Park, Park, circulareconomy and rapid economic development. Focus more on the dialectical relationship between development and environmental protection, energy saving and emission reduction projects play an important role. Vigorously developing agriculture, ecological agriculture, agriculture, modern agricultural clearing along the River Promenade begins to take shape. Key tourism projects is going well, WA Palace area was named \"top ten most influential cultural relics in Hebei province landscape\". Develop new services, and services with new developments. (C) urban-rural integration process. Promoting \"three-year difference\" campaign, battle of two large demolition completed 32 days of 530,000 square meters, exceeded the annual ask 7 months in advance. General big building jiangjun road, bridge and highway bridges, the green heart of the city and other urban construction projects, and focus on building new countryside and new housing model villages, urban and rural areas improve. Highwayopened to traffic, Liu Zhang, Qing LAN high-speed x-County section completed by the end of August. Urban and rural仅需经一次申请、一次审评、一次批准即可在欧盟所有成员国销售。凡采用重组DNA、基因表达和单克隆抗体等生物技术生产的产品，必须遵循集中程序。其他如采用了新技术生产的药品、新化学实体或在作用机制、适应证方面具有新颖性的产品，其生产企业也可以选择这一程序。非成员国向欧盟申请上市的上述药品亦按此程序向EMEA申请。
除必须采用集中申请程序的生物技术外，自1995年1月1日起，制药企业希望自己生产的药品能在多个成员国上市，因此制定了非集中申请程序。其具体过程为：生产企业首先向第一个成员国当局提交上市申请及技术资料，经审评，如果该局同意上市，应在210天内写出评价报告。若申请者在同时或其后向其他成员国当局申请上市，这些成员国可暂停审评。待第一成员国批准该药上市后，申请者可以请求第一成员国写出有关该药的最新评价报告(包括上市后评价)，送至其他成员国，进入共识过程（又叫互认过程）。其他成员国在接到申请及评价报告后90天内必须作出反应，如果意见一致，则可予以上市许可，如果有严重的意见分歧，则提交EMEA的CPMP(人用专卖药品委员会)予以仲裁。
摘自《中国医药报》
欧盟GMP法规制度简介（三）
中国药科大学 梁 毅 王 莉
evelopment work steadily in the pilot counties, to build peace neighborhood offices approved, \"change\ban and rural communities (Center), immigrant communities, pilot projects such as integrated management of urban and rural sanitation in order. (D) maintain social harmony and stability. In the case of tight financial situation, continue to increase the input of people, happy people battle. Urban central heating and upgrade rural power grids, rural reconstruction of shabby housing ten major projects being delivered, has been overfulfilled ahead. Strengthening of social programs, college entrance examination to record heights; new rural insurance coverage rate of the city's first, launched in new rural cooperative medical clinic co-ordination; ... Perfect Park catering, accommodation, education, recreation and other tertiary industries supporting, improving socialization service level, for industries, businesses and create a good environment for development. 3, flexible investment, enhancethe industry. Construction of industrial parks, just set up a platform for the development of only attract more projects into the district, to form agglomeration advantages. A innovation project. To be purposeful, targeted investment, will have a basis of the County's industrial packaged bundles, overall publicity and promotion. Initiative going, please come in and carry out all-round, multi-level and wide-range of investment activities. The Township industrial projects, in principle, to put to the West industrial parks. What town project, is that the output value of the Township. Second, we must grasp the standards selected items. Full account of extend the industry chain and the integration of factors of production, not only efforts to introduce a number of scientific and technological content and high added value, growth and strong driving force of large projects and large enterprises, but also on domestic-funded enterprises and in accordance with the direction of industrial development of small and medium projects, project man, small project overwhelming. Meet the area of the County's new industrial projects and city back into rural enterprises, in principle, all stationed in industrial parks. Meanwhile, strict control of excess capacity and high energy consumption, high emission enterprises to enter. Thirdly, increased incentives on the project. Investment of the whole society, the ownship and County units go out and draft project. o establish investment incentives for successful introduction of significant project gives awards to units and individuals, the introduction of tax for the implementation of the project, to introduce organization into rewards. 4, preferential policies, and security industries. In terms of project examination and approval, by area Administrative Committee in conjunction with the development, planning, land, industry and commerce, quality control and other departments, \"one-stop reception, one-stop service\he simplified procedures, the time limit originally. In the management of EIA in accordance with theBuilding industry opens up new world of entrepreneurial struggle to build a three provinces of regional central cities--in the Communist x counties the six plenary session members and comrades: today, I was commissioned by the County party Committee Standing Committee, reports to the General Assembly. Consideration of all members and alternates, and comrades attending advice. A, and this year yilai of work recalled this year yilai, in municipal of right led Xia, County solidarity led County people, to science development views for guide, to good activities for mainline, according to \"a city four modernizations three more\" of development thought, concentrated poly force, work hard, political, and economic, and culture, and social and party of construction are made has new progress, County rendering out wind fresh are, and career prosperity, and social settled, and people mind into of good situation. (A) facilitating the construction of the project. Firmly establish the \"scratch project is economic, grasping development project is to hold\" philosophy, to extraordinary efforts to promoting the construction of key projects. Plot 108 key projects for the year, with a total investment of 29.3 billion yuan, iron plate, Josh stone cement waste heat power generation and 13 projects completed, worship of 1.2 million tons of pellets, Hua Yu 80,000 sets of grandparent chicken farming, 47 projects under construction, completed investmnt of 3.95 billion yuan, annual plan of 69.3%. The first half of the County's gross domestic product is expected to reached 8.5 billion yuan, and total revenue of 943 million Yuan. (B) structural adjustment achieved remarkable results. Actively transforming the pattern of economic development, industrial ecology, and agricultural modernization and industrialization of services. High x-County • Tin iron circular economy demonstration area, and further expand economic development zone Jing Dian recycle economy ecology industry Park, Park, circulareconomy and rapid economic development. Focus more on the dialectical relationship between development and environmental protection, energy saving and emission reduction projects play an important role. Vigorously developing agriculture, ecological agriculture, agriculture, modern agricultural clearing along the River Promenade begins to take shape. Key tourism projects is going well, WA Palace area was named \"top ten most influential cultural relics in Hebei province landscape\". Develop new services, and services with new developments. (C) urban-rural integration process. Promoting \"three-year difference\" campaign, battle of two large demolition completed 32 days of 530,000 square meters, exceeded the annual ask 7 months in advance. General big building jiangjun road, bridge and highway bridges, the green heart of the city and other urban construction projects, and focus on building new countryside and new housing model villages, urban and rural areas improve. Highwayopened to traffic, Liu Zhang, Qing LAN high-speed x-County section completed by the end of August. Urban and rural
欧盟GMP的演进
1970年10月，欧洲自由贸易区(EFTA)在“关于药品生产的现场检查的互认协定”主题下成立了药品检查条约组织(PIC)。1995年欧盟成立，PIC在接受新成员的问题上出现了与欧盟法律的不相容性，因为只有欧盟委员会才被允许与欧洲以外的国家签署协议，而欧盟委员会本身并不是PIC成员，作为一种变通的方式，PIC采用各国卫生当局之间的合作协议来代替国家之间的法定条约，成立了以协作方案方式构成的协议组织PIC Scheme(药品检查合作计划组织)。1995年2月，PIC与PIC Scheme共同工作，统称为PIC/S。PIC/S的目的是促进各参与国药品GMP检查当局的联系以及保持相互间的信任，交换GMP检查及相关领域的信息、经验，并提供对检查员的培训。
PIC/S基于药品认证互认的目的，专门针对药品GMP监督检查的质量提出了严格要求，具体概括如下:1.建立了检查员管理的系列规定，详细规定了检查员的资质要求、职责、培训等。2.建立了检查的文件体系，以确保检查机构的所有活动均通过标准操作规程(SOP)明确描述，包括培训、检查、检查报告、处理投诉、许可证管理(发放、吊销及撤回)、证书、文件管理、计划和处理上诉等。3.对于检查记录有详细的书写要求，且与检查活动相关的记录至少应保存3个完整的检查周期或者6年。4.有明确的对生产企业实施检查的程序规定。对于生产企业的检查，至少每年一次或两年一次。5.制定了检查质量手册，其中对质量方针、GMP检查的法律地位、检查活动中的道德准则和行为规范等均有详细规定。6.制订了关于保密性方面的工作人员守则，要求所有工作人员都应书面承诺不向第三方泄露任何关于当事人商业信息的情况。7.建立了GMP检查机构内部审核和定期评审制度。
1972年，《GMP总则》颁布，用于指导欧共体国家的药品生产。1989年
evelopment work steadily in the pilot counties, to build peace neighborhood offices approved, \"change\ban and rural communities (Center), immigrant communities, pilot projects such as integrated management of urban and rural sanitaton in order. (D) maintain social harmony and stability. In the case of tight financial situation, continue to increase the input of people, happy people battle. Urban central heating and upgrade rural power grids, rural reconstruction of shabby housing ten major projects being delivered, has been overfulfilled ahead. Strengthening of social programs, college entrance examination to record heights; new rural insurance coverage rate of the city's first, launched in new rural cooperative medical clinic co-ordination; ... Perfect Park catering, accommodation, education, recreation and other tertiary industries supporting, improving socialization service level, for industries, businesses and create a good environment for development. 3, flexible investment, enhancethe industry. Construction of industrial parks, just set up a platform for the development of only attract more projects into the district, to form agglomeration advantages. A innovation project. To be purposeful, targeted investment, will have a basis of the County's industrial packaged bundles, overall publicity and promotion. Initiative going, please come in and carry out all-round, multi-level and wide-range of investment activities. The Township industrial projects, in principle, to put to the West industrial parks. What town project, is that the output value of the Township. Second, we must grasp the standards selected items. Full account of extend the industry chain and the integration of factors of production, not only efforts to introduce a number of scientific and technological content and high added value, growth and strong driving force of large projects and large enterprises, but also on domestic-funded enterprises and in accordance with the direction of industrial development of small and medium projects, project man, small project overwhelming. Meet the area of the County's new industrial projects and city back into rural enterprises, in principle, all stationed in industrial parks. Meanwhile, strict control of excess capacity and high energy consumption, high emission enterprises to enter. Thirdly, increased incentives on the project. Investment of the whole society, the Township and County units go out and draft project. o establish investment incentives for successful introduction of significant project gives awards to units and individuals, the introduction of tax for the implementation of the project, to introduce organization into rewards. 4, preferential policies, and security industries. In terms of project examination and approval, by area Administrative Committee in conjunction with the development, planning, land, industry and commerce, quality control and other departments, \"one-stop reception, one-stop service\he simplified procedures, the time limit originally. In the management of EIA in accordance with theBuilding industry opens up new world of entrepreneurial struggle to build a three provinces of regional central cities--in the Communist x counties the six plenary session members and comrades: today, I was commissioned by the County party Committee Standing Committee, reports to the General Assembly. Consideration of all members and alternates, and comrades attending advice. A, and this year yilai of work recalled this year yilai, in municipal of right led Xia, County solidarity led County people, to science development views for guide, to good activities for mainline, according to \"a city four modernizations three more\" of development thought, concentrated poly force, work hard, political, and economic, and culture, and social and party of construction are made has new progress, County rendering out wind fresh are, and career prosperity, and social settled, and people mind into of good situation. (A) facilitating the construction of the project. Firmly establish the \"scratch project is economic, grasping development project is to hold\" philosophy, to extraordinary efforts to promoting the construction of key projects. Plot 108 key projects for the year, with a total investment of 29.3 billion yuan, iron plate, Josh stone cement waste heat power generation and 13 projects completed, worship of 1.2 million tons of pellets, Hua Yu 80,000 sets of grandparent chicken farming, 47 projects under construction, completed investment of 3.95 billion yuan, annual plan of 69.3%. The first half of the County's gross domestic product is expected to reached 8.5 billion yuan, and total revenue of 943 million Yuan. (B) structural adjustment achieved remarkable results. Actively transforming the pattern of economic development, industrial ecology, and agricultural modernization and industrialization of services. High x-County • Tin iron circular economy demonstration area, and further expand economic development zone Jing Dian recycle economy ecology industry Park, Park, circulareconomy and rapid economic development. Focus more on the dialectical relationship between development and environmental protection, energy saving and emission reduction projects play an important role. Vigorously developing agriculture, ecological agriculture, agriculture, modern agricultural clearing along the River Promenade begins to take shape. Key tourism projects is going well, WA Palace area was named \"top ten most influential cultural relics in Hebei province landscape\". Develop new services, and services with new developments. (C) urban-rural integration process. Promoting \"three-year difference\" campaign, battle of two large demolition completed 32 days of 530,000 square meters, exceeded the annual ask 7 months in advance. General big building jiangjun road, bridge and highway bridges, the green heart of the city and other urban construction projects, and focus on building new countryside and new housing model villages, urban and rural areas improve. Highwayopened to traffic, Liu Zhang, Qing LAN high-speed x-County section completed by the end of August. Urban and rural1月，欧共体第一版《GMP指南》出版，两年后对其进行了修订，于1992年1月公布了第二版《欧洲共同体药品生产质量管理规范》，该版GMP执行了1991年6月13日和1991年7月23日分别发布的欧盟法令91／356和91／412——确立了人用药品和兽药的GMP原则和指导文件，包含12个新增附录。2005年10月，欧盟委员会重新调整了《GMP指南》结构，由第一部分人用药品和兽药GMP以及第二部分原料药GMP组成，第二部分是根据人用药品注册技术要求国际协调会(ICH)的Q7A“原料药GMP”新制定的指南，该部分取代了原先的附录18，它同时适用于人用药品及兽药。2009年11月18日，欧盟委员会在其官方网站上发布了欧盟GMP第一章与第二章的修订征求意见稿，在修订稿中明确表示即将使ICH在2008年6月4日发布的Q10“制药质量体系指南”成为欧盟GMP的第21附件。此次《GMP指南》对修订原则做了如下阐述：制造许可的持有人必须制造确保适合预期用途符合上市许可要求的药品，不能由于安全性、质量或有效性不足而将患者置于风险之中。
摘自《中国医药报》
evelopment work steadily in the pilot counties, to build peace neighborhood offices approved, \"change\ban and rural communities (Center), immigrant communities, pilot projects such as integrated management of urban and rural sanitation in order. (D) maintain social harmony and stability. In the case of tight financial situation, continue to increase the input of people, happy people battle. Urban central heating and upgrade rural power grids, rural reconstruction of shabby housing ten major projects being delivered, has been overfulfilled ahead. Strengthening of social programs, college entrance examination to record heights; new rural insurance coverage rate of the city's first, launched in new rural cooperative medical clinic co-ordination; ... Perfect Park catering, accommodation, education, recreation and other tertiary industries supporting, improving socialization service level, for industries, businesses and create a good environment for development. 3, flexible investment, enhancethe industry. Construction of industrial parks, just set up a platform for the development of only attract more projects into the district, to form agglomeration advantages. A innovation project. To be purposeful, targeted investment, will have a basis of the County's industrial packaged bundles, overall publicity and promotion. Initiative going, please come in and carry out all-round, multi-level and wide-range of investment activities. The Township industrial projects, in principle, to put to the West industrial parks. What town project, is that the output value of the Township. Second, we must grasp the standards selected items. Full account of extend the industry chain and the integration of factors of production, not only efforts to introduce a number of scientific and technological content and high added value, growth and strong driving force of large projects and large enterprises, but also on domestic-funded enterprises and in accordance with the direction of industrial development of small and medium projects, project man, small project overwhelming. Meet the area of the County's new industrial projects and city back into rural enterprises, in principle, all stationed in industrial parks. Meanwhile, strict control of excess capacity and high energy consumption, high emission enterprises to enter. Thirdly, increased incentives on the project. Investment of the whole society, the ownship and County units go out and draft project. o establish investment incentives for successful introduction of significant project gives awards to units and individuals, the introduction of tax for the implementation of the project, to introduce organization into rewards. 4, preferential policies, and security industries. In terms of project examination and approval, by area Administrative Committee in conjunction with the development, planning, land, industry and commerce, quality control and other departments, \"one-stop reception, one-stop service\he simplified procedures, the time limit originally. In the management of EIA in accordance with the
因篇幅问题不能全部显示，请点此查看更多更全内容