国家工商行政管理局、对外贸易经济合作部关于设立外商投资广告企业的若干规定(附英文)
国家工商局 对对外贸易经济合作部
国家工商行政管理局、对外贸易经济合作部关于设立外商投资广告企业的若干规定(附英文)
1994年11月3日，国家工商管理局、对外经贸部
第一条 为了更好地推动我国广告业为对外开放服务，保证外商投资广告企业的质量，促进我国广告业健康发展，制定本规定。
第二条 本规定所称外商投资广告企业，是指中外合资、合作经营广告业务的企业。
第三条 设立外商投资广告企业，应当遵循《中华人民共和国中外合资经营企业法》、《中华人民共和国中外合作经营企业法》、《中华人民共和国广告法》、《广告管理条例》、《广告经营者资质标准及广告经营范围核定用语规范》等有关法律、法规、规章。
第四条 外商投资广告企业的项目建议书和可行性研究报告，由国家工商行政管理局审定。外商投资广告企业的经营范围，由国家工商行政管理局依据《广告经营者资质标准及广告经营范围核定用语规范》，根据外商投资广告企业的类型，按设计、制作、发布、代理国内外广告业务的不同范围，分别予以核定。外商投资广告企业的合同和章程，由对外贸易经济合作部审查批准。
第五条 设立外商投资广告企业，按下列程序办理：
（一）外商投资广告企业的中方合营（含合作，下同）者，向所在地有外商投资企业核准登记权的工商行政管理局呈报设立外商投资广告企业的项目建议书和可行性研究报告，由其提出初审意见，经省、自治区、直辖市及计划单列市工商行政管理局核转，报国家工商行政管理局审定。
中方合营者为国务院部、委、局直属企业的，中方合营者向其主管部门呈报设立外商投资广告企业的项目建议书和可行性研究报告，经审核同意后，转报国家工商行政管理局审定。
国家工商行政管理局自收到全部呈报文件之日起三十天内，作出同意或不同意的决定。
（二）国家工商行政管理局颁发《外商投资广告企业项目审定意见书》后，由中方合营者向所在地外经贸部门呈报设立外商投资广告企业的合同和章程，经省、自治区、直辖市、计划单列市外经贸部门核转，报对外贸易经济合作部审批。
中方合营者为国务院部、委、局直属企业的，中方合营者向其主管部门呈报设立外商投资广告企业的合同、章程。主管部门审核同意后，转报对外贸易经济合作部审批。
对外贸易经济合作部依照国家有关外商投资的法律、法规，在规定的期限内决定批准或不批准。
（三）中方合营者持国家工商行政管理局颁发的《外商投资广告企业项目审定意见书》和对外贸易经济合作部颁发的批准证书及法律、法规规定的其他文件，按企业登记注册的有关规定，向国家工商行政管理局或有外商投资企业核准登记权的地方工商行政管理局办理企业法人登记注册手续。
外商投资广告企业申请设立分支机构，由省、自治区、直辖市、计划单列市外经贸部门或国务院部、委、局审核同意后，转报对外贸易经济合作部，对外贸易经济合作部在征求国家工商行政管理局意见后，决定批准或不批准。
第六条 设立外商投资广告企业，除符合有关法律、法规规定的条件外，还应具备以下条件：
（一）合营各方必须是具有一定规模的以经营广告业务为主的企业法人；
（二）能够引进国际先进的广告制作技术和设备；
（三）具有市场调查、广告策划和广告效果测定等能力；
（四）能够在广告策划、创意、设计、制作和经营管理等方面培训中国职员；
（五）注册资本不低于30万美元。
第七条 申请设立分支机构的外商投资广告企业，应具备以下基本条件：
（一）注册资本全部缴清；
（二）年营业额不低于2000万元人民币；
（三）分支机构所在地须有3个以上相对固定的广告客户。
第八条 申请设立外商投资广告企业，由中方合营者按本规定第五条规定的程序，向国家工商行政管理局报送下列文件：
（一）申请设立外商投资广告企业的报告；
（二）中方合营者所属主管部门的批准文件；
（三）设立外商投资广告企业的项目建议书；
（四）合营各方共同编制的可行性研究报告；
（五）合营各方的登记注册证明；
（六）合营各方的资信证明；
（七）采用的主要制作设备、技术及其来源证明；
（八）广告管理制度；
（九）地方工商行政管理局的初审意见。
第九条 申请设立外商投资广告企业，应按本规定第五条规定的程序，向对外贸易经济合作部报送下列文件：
（一）地方外经贸部门或国务院部、委、局的报送文件；
（二）国家工商行政管理局颁发的《外商投资广告企业项目审定意见书》；
（三）设立外商投资广告企业的合同、章程；
（四）项目建议书及可行性研究报告；
（五）合营各方的登记注册证明；
（六）合营各方的资信证明；
（七）工商行政管理部门出具的名称核准书；
（八）合营企业的董事会名单及各方董事委派书。
第十条 外商投资广告企业通过审查取得批准证书后，如出现下列情况之一的，应按本规定第五条规定的程序另行报批：
（一）更换合营方；
（二）变更经营范围。
第十一条 外商投资企业申请增加广告经营业务的，参照本规定办理。
第十二条 本规定自一九九五年一月一日起施行。
Regulations of the State Administration for Industry and Commerceand the Ministry of Foreign Trade and Economic Cooperation for Establi-shing Foreign-Invested Advertising Enterprises
(Promulgated on November 3, 1994)
Whole document
Regulations of the State Administration for Industry and Commerce and the
Ministry of Foreign Trade and Economic Cooperation for Establishing
Foreign-Invested Advertising Enterprises
(Promulgated on November 3, 1994)
Article 1
These Regulations are hereby formulated with a view to promoting the
advertising industry of China to serve for the open-to-the-outside-world,
assuring the high quality of the foreign-invested advertising enterprises,
and pushing forward the healthy development of the advertising industry of
China.
Article 2
For the purpose of these Regulations, the term "foreign-invested
advertising enterprises" means the enterprises that are engaged in
advertising business in the form of either a Chinese-Foreign equity joint
venture or a Chinese-foreign cooperative joint venture.
Article 3
To apply for the establishment of a foreign-invested advertising
enterprise, related laws, regulations and rules shall be followed, such
as Law of the People's Republic of China on Chinese-foreign Equity Joint
Ventures, Law of the People's Republic of China on Chinese-foreign
Cooperative Joint Ventures, The Advertising Law of the People's Republic
of China, Regulations on Advertising Administration, Qualification
Standards of Advertising Operators and Phraseology Norm for the
Examination and Ratification of the Advertising Business Scope, etc.
Article 4
The project proposals and the feasibility study reports of
foreign-invested advertising enterprises shall be examined and approved by
the State Administration for Industry and Commerce. The business scopes of
foreign-invested advertising enterprises that are classified as the
different scopes like designing, producing, media-buying and acting for
advertising business both at home and abroad, shall be approved by the
State Administration for Industry and Commerce, in accordance with The
Qualification Standards of Advertising Operations and Phraseology Norm for
the Examination and Ratification of the Advertising Business Scope and in
the light of the different types of foreign-invested advertising
enterprises. The contracts and the articles of association of
foreign-invested advertising enterprises shall be examined and approved by
the Ministry of Foreign Trade and Economic Cooperation.
Article 5
For the establishment of a foreign-invested advertising enterprise,
the following procedures shall be followed:
(1) The Chinese party to an equity joint venture advertising
enterprise (including the party to Chinese-foreign cooperative joint
venture, similarly hereinafter) shall submit the project proposal and
feasibility study report for the establishment of a foreign-invested
advertising enterprise to the local administration for industry and
commerce which is authorized to ratify and register enterprises with
foreign investment. With the preliminary examination comments of the local
administration, the administration for industry and commerce at the level
of province, autonomous region, municipality directly under the Central
Government or the municipalities specifically listed in the State plan
shall examine and transfer those documents to the State Administration for
Industry and Commerce for final examination and approval.
In case the Chinese Party is an enterprise directly under the
ministries, commissions or bureaus of the State Council, the Chinese party
shall submit to the department in charge the project proposal and
feasibility study report for the establishment of a foreign-invested
advertising enterprise. Upon examination and consent by the department in
charge, those documents shall be submitted to the State Administration for
Industry and Commerce for final examination and approval.
Upon receipt of all the documents required, the State Administration
for Industry and Commerce shall, within 30 days, make a decision of
approval or disapproval over the establishment of the foreign-invested
advertising enterprise.
(2) After the issuance of the "Certificate of Examination and Approval
Opinions for Foreign-Invested Advertising Enterprises" by the State
Administration for Industry and Commerce, the Chinese party shall submit
the contract and articles of association of the foreign-invested
advertising enterprise to the local foreign trade, and after being
checked by the foreign trade and economic cooperation authorities at the
level of province, autonomous region, municipality directly under the
Central Government or the municipalities specifically listed in the State
plan, the relative documents shall be transferred to the Ministry of
Foreign Trade and Economic Cooperation for final examination and approval.
In case the Chinese party is an enterprise directly under the
ministries, commissions or bureaus of the State Council, the Chinese party
shall submit to the department in charge the contract and articles of
association for the establishment of a foreign-invested advertising
enterprise. After being checked and consented by the department in charge,
the documents mentioned-above shall be transferred to the Ministry of
Foreign Trade and Economic Cooperation for final examination and approval.
The Ministry of Foreign Trade and Economic Cooperation shall,
according to the State laws and regulations governing foreign investment,
decide whether to approve or disapprove the establishment of such an
enterprise within the stipulated time limits.
(3) The Chinese party shall, with the "Certificate of Examination and
Approval Opinions for Foreign-invested Advertising Enterprises" issued by
the State Administration for Industry and Commerce, the approval
certificate issued by the Ministry of Foreign Trade and Economic
Cooperation and other documents stipulated by the laws and regulations,
submit, according to the relative regulations on enterprise registration,
to the State Administration for Industry and Commerce or the local
administrations for industry and commerce authorized to check and register
enterprises with foreign investment for handling the formalities of
registration for an enterprise legal person.
The application of a foreign-invested advertising enterprise for
setting up a branch shall be examined and approved by the foreign trade
and economic cooperation department of the province, autonomous region,
municipality directly under the Central Government or the municipalities
specifically listed in the State plan, and then transferred to the
Ministry of Foreign Trade and Economic Cooperation which shall, after
gathering opinions from the State Administration for Industry and
Commerce, decide whether to approve or disapprove it.
Article 6
To apply for establishing a foreign-invested advertising enterprise,
the following conditions shall be fulfilled in addition to the conditions
stipulated in the relative laws and regulations:
(1) all parties to a foreign-invested advertising enterprise must be a
fair-sized enterprise legal person which is mainly engaged in advertising
business;
(2) being able to introduce the world's advanced advertising
technology and equipment;
(3) having the capability for market investigation, advertising plan
and advertising effect measurement;
(4) being able to train the Chinese personnel in the aspects of
advertising plan, creation, design, production and management; and
(5) the registered capital being no less than US $ 300000.
Article 7
The foreign-invested advertising enterprise which intends to apply for
setting up a branch shall fulfill the following main conditions:
(1) the registered capital has been contributed in full;
(2) the annual volume of business shall not be lower than RMB 20
million yuan; and
(3) in the place where the branch is to be located, there must be
more than 3 relatively permanent advertising customers.
Article 8
When applying for the establishment of a foreign-invested adverting
enterprise, the Chinese party shall, according to the stipulations set
forth in Article 5 of these Regulations, submit to the State
Administration for Industry and Commerce the following documents:
(1) the application report for the establishment of a foreign-invested
advertising enterprise;
(2) the approval documents issued by the department in charge of the
Chinese party;
(3) the project proposal for the establishment of a foreign-invested
advertising enterprise;
(4) the feasibility study report worked out jointly by all the
parties;
(5) the registration testimonials for each party;
(6) the financial credit documents for each party;
(7) the documents for the main equipment used and technology adopted,
and their original sources;
(8) its advertising administration system; and
(9) the preliminary examination opinions of the local administrations
for industry and commerce.
Article 9
When applying for the establishment of a foreign-invested advertising
enterprise, the Chinese party shall, in accordance with the procedure
provided in Article 5 of these Regulations, submit to the Ministry of
Foreign Trade and Economic Cooperation the following documents:
(1) the documents reported by local foreign trade and economic
cooperation departments or the ministries, commissions or bureaus
directly under the State Council;
(2) the "Certificate of Examination and Approval Opinions for
Foreign-invested Advertising Enterprises" issued by the State
Administration for Industry and Commerce;
(3) the contract and articles of association for the establishment of
the foreign-invested advertising enterprise;
(4) the project proposal and feasibility study report;
(5) the registration testimonials for each party;
(6) the financial credit documents for each party;
(7) the verification and approval documents for the name of the
enterprise issued by the administration authorities for industry and
commerce; and
(8) the name list of members of the board of directors and the
appointment documents for the directors from each party.
Article 10
Even after obtaining the approval certificate through examination, the
foreign-invested advertising enterprise shall, according to the procedure
stipulated in Article 5 of these Regulations, apply for approval in any of
the following cases:
(1) to change any party; or
(2) to change the business scope.
Article 11
These Regulations shall be applicable as a measure of reference to
enterprises with foreign investment if they apply for enlarging their
business scope to advertising business.
Article 12
These Regulations shall come into force as of January 1, 1995.
国务院办公厅关于进一步加强药品安全监管工作的通知
国务院办公厅
国务院办公厅关于进一步加强药品安全监管工作的通知
国办发〔2007〕18号
各省、自治区、直辖市人民政府，国务院各部委、各直属机构：
经过连续几年的药品（含医疗器械）专项整治，人民群众反应强烈的制售假劣药品的违法犯罪活动得到有效遏制，药品市场秩序总体好转。但是，期间发生的大案和药害事件特别是郑筱萸等人严重违纪违法案件，暴露出药品安全监管工作中存在着突出问题和薄弱环节。因此，必须有针对性地进一步加强药品安全监管工作，切实保障人民群众用药安全。经国务院同意，现就有关问题通知如下：
一、树立正确的指导思想
（一）按照科学发展观的要求，牢固树立正确的药品监管指导思想和科学监管理念，准确把握工作定位，正确处理政府与企业、监管与服务、公众利益与商业利益的关系，依法履行监管职责，维护政府药品安全监管的公信力，让人民群众用上安全有效的药品。
二、落实地方政府的责任
（二）地方各级人民政府要对本地区药品安全工作负总责。要加强组织领导，把药品安全工作纳入重要议事日程，切实担负起保障本地区药品安全的责任。要定期评估和分析本地区药品安全状况，针对主要问题和薄弱环节，研究采取相应措施。支持药品监管部门依法履行职责，创造良好的执法环境，不得要求药品监管部门承担经济发展指标和行业发展任务，更不得干扰药品监管部门正常监管执法。
（三）地方各级人民政府要完善重大药品安全事件应急机制。一旦本行政区域内发生药品安全事件，要组织协调有关部门积极应对，有效处置，消除危害；正确引导舆论，稳定群众情绪，防止事态蔓延。
（四）严格实施药品安全行政领导责任制和责任追究制。对于因领导不力、疏于监管导致发生重大药品安全事件的地区，要依纪依法追究相关负责人的责任。
三、抓住关键环节和突出问题
（五）加强药品研制、生产、流通、使用等关键环节的管理，打击虚假申报行为，严格审评审批药品，建立健全药品市场准入和退出制度，把好市场准入关。全面检查《药品生产质量管理规范》（GMP）执行情况，加强对药品生产企业的动态监管，推进中药材生产质量管理规范化。规范药品经营主体行为，提高临床合理用药水平。加快实施药品安全科技行动计划。
（六）各地区、各部门要按照《国务院办公厅关于印发全国整顿和规范药品市场秩序专项行动方案的通知》（国办发〔2006〕51号）的要求，深入开展药品安全专项整治，巩固和扩大整治成果，扭转药品生产和流通等领域监督和管理不力的局面，最大限度防控和减少药害事件发生。
（七）认真清理药品批准文号，重点清理1999-2002年地方标准升国家标准品种，坚决淘汰安全性、有效性得不到保证的品种。同时，加快完善药品审评审批制度，科学制订药品标准，规范新药品、仿制药品的申报资料要求，坚决纠正药品注册申报秩序混乱、研制资料弄虚作假等问题。
（八）进一步强化企业作为药品安全第一责任人的责任。要规范企业生产经营行为，教育和引导企业守法经营，强化自律意识，完善内部管理制度，坚决杜绝不合格原料、药品进厂进店，不合格产品出厂出店。加强对药品质量的监督抽验工作，凡是在企业成品库待出厂的药品，经抽查检验达不到国家药品标准，并经复检后仍不合格的，加大处罚和曝光力度。同时，采取措施支持诚信企业扩大生产规模，提高管理和技术水平，健全质量保障体系。建立企业诚信档案，推进企业诚信体系建设。要充分发挥行业协会自律作用，引导和约束企业诚信生产经营。
（九）高度重视农村药品安全工作，建立健全农村药品监督网和供应网，鼓励药品生产批发企业面向农村配送药品，支持零售企业向农村延伸网点。加强农村药房规范化建设，规范农村医疗机构药品购销渠道，提高农民安全用药水平。
四、加强基础设施和技术能力建设
（十）结合实施《国家食品药品安全“十一五”规划》，充分利用现有资源和基础，加强药品检验、药品再评价、药品不良反应监测等方面的技术能力建设，不断提高药品安全监测分析、信息通报和公共服务水平。完善相关标准和认证体系。
（十一）运用计算机网络等现代科技手段，加强药品安全信息管理和综合利用，构建地区和部门间信息沟通平台，建立和完善覆盖全国的药品安全监管信息系统，实现监管信息互联互通和监管资源综合利用，使药品安全问题早发现、早整治、早解决。
（十二）增加对药品安全监管基础设施建设资金投入，加快药品监管部门技术支撑体系建设，改善基层监督执法条件。加大对药品安全监管工作经费的投入，逐步提高经费保障水平。
五、完善制度保障
（十三）加快完善药品安全法律法规体系。在查找监管漏洞的基础上，有计划地推进药品安全监管法律法规和规章制度的制订、修订工作，重点抓好药品审评审批、药品分类管理、医疗器械监督以及中药品种保护等行政法规和部门规章的制定和修订工作。
（十四）深化药品审批制度改革，进一步完善受理、审评、审批“三分离”制度，建立健全有效监督审批权力的机制。实行审评主审集体负责制，审评人员公示制和审评审批责任追究制，加快信息化建设，逐步实行审批事项的网上受理、网上审批，建立健全审评审批权力的内外部监督制约机制。
（十五）强化权力监督和制约，研究建立结构合理、配置科学、程序严密、监督有效的权力运行机制，做到用制度管权、按制度办事、靠制度管人，防止滥用权力和以权谋私现象发生。
六、加强队伍建设
（十六）加强药品安全监管有关部门领导干部廉洁自律教育和干部队伍建设，严格要求、严格教育、严格管理和严格监督，不断提高队伍的整体素质。
（十七）加强对药品安全监管重点岗位干部的选拔任用管理，实行定期交流，并形成制度；对监管人员的监督、管理、培养、使用要实行民主决策，做到公开透明。要强化主要负责人作为党风廉政建设第一责任人的责任，层层落实党风廉政责任制和责任追究制。
七、加强部门协作
（十八）各有关部门要认真履行职责，密切配合，加强协作，不断提高人民群众用药安全水平。药品监管部门要切实加强药品研制、生产、流通、使用全过程的监管，依法严厉查处各种违法违规行为。卫生部门要严格医疗机构药品使用管理，促进合理用药。工商部门要严厉查处发布虚假违法药品广告行为。有关行政执法部门要及时向公安机关移送涉嫌犯罪的制售假劣药品案件，公安机关要加大对制售假劣药品违法犯罪活动的打击力度。监察部门要严厉查处有关部门和行业滥用职权、玩忽职守、徇私舞弊等违法乱纪现象，严肃追究相关人员的行政责任。新闻宣传部门要做好加强药品安全新闻宣传和舆论引导工作。
国务院办公厅
二○○七年三月三十一日
