中华人民共和国药品管理法实施办法
 
发布时间：2008-08-04 来源：翻译中国 发布者：上海翻译公司


【发布时间】1989年2月27日

【实施时间】1989年2月27日

【发布部门】国务院

【正文】

【标 题】 中华人民共和国药品管理法实施办法
【发布时间】 1989-2-27
【发布部门】 国务院
【有 效 性】 有效
第一章 总则
第一条 根据《中华人民共和国药品管理法》（以下称《药品管理法》）的规定，制定本办法。
第二条 本办法适用于所有有关药品生产、经营、使用、检验、科研的单位和个人。军队的药品生产企业生产民用药品的, 适用本办法。
第三条 药品的生产、经营, 应当把社会效益放在第一位, 严禁生产、经营、使用假药或者劣药。严禁未经许可生产、经营药品和配制制剂。
第二章 药品监督管理职责
第四条 国务院卫生行政部门主管全国药品监督管理工作, 其主要职责是:(一)执行《药品管理法》及本办法;(二)起草有关药品监督管理的法规, 制定配套的单行办法;(三)颁布《中国药典》和药品标准;(四)审批新药、核发药品批准文号;(五)对药品的生产、经营、使用进行监督;(六)级织对已经生产的药品的药效、副作用进行调查和再评价, 并及时提供和公布有关质量方面的资料;(七)依照《药品管理法》和本办法决定行政处罚。县以上地方各级卫生行政部门的药政机构主管所辖行政区的药品监督管理工作。
第五条 县级以上卫生行政部门设置的药品检验所, 在同级卫生行政部门的领导下, 按照国家药品标准和省、自治区、直辖市的药品标准对药品进行检验。
第六条 县级以上卫生行政部门设药品监督员, 国家药品监督员由国务院卫生行政部门审核发给证书; 省、自治区、直辖市药品监督员和自治州、市或者县的药品监督员由卫生行政部门提名, 同级人民政府审核发给证书。药品监督员的职责由国务院卫生行政部门另行规定。
第七条 药品监督员在履行职责时, 应出示证件, 按照国家有关规定抽取样品和索取有关资料并开具清单。对药品生产企业和科研单位提供的保密的技术资料, 应当承担保密责任。药品监督员对暂行封存待处理的药品, 应注明封存期限, 该期限一般不得超过15天。
第三章 审核批准许可证的程序
第八条 《药品管理法》第四条第一款规定的审批程序, 是指开办药品生产企业(包括各种形式的联营、中外合资企业、中外合作企业以及外资企业), 除按照国家规定履行基本建设报批程序以外, 必须依次履行下列程序:(一)由企业或者企业的上级部门向所在省、自治区、直辖市的药品生产经营主管部门申报, 经审查同意后, 送同级卫生行政部门;(二)经所在省、自治区、直辖市卫生行政部门审核批准, 发给《药品生产企业许可证》。药品生产经营主管部门和卫生行政部门应当在各自收到全部申报材料后的30日内, 作出是否同意或者批准的决定。
第九条 药品生产企业另设分厂或者在厂区外另设车间的, 由药品生产企业向分厂或者车间所在地的省、自治区、直辖市药品生产经营主管部门申报, 经审查同意后, 送同级卫生行政部门申请办理《药品生产企业许可证》。《药品生产企业许可证》应注明分厂(车间)和生产范围。
第十条 《药品管理法》第十条第一款规定的审批程序, 是指药品经营企业(包括专营或者兼营的批发、零售商店或者公司)按照以下规定申请办理《药品经营企业许可证》:(一)经营药品批发业务的企业, 由省、自治区、直辖市的药品生产经营主管部门审查同意, 经省、自治区、直辖市卫生行政部门审核批准, 发给《药品经营企业许可证》;(二)经营药品零售业务, 由所在地的自治州、市或者县的药品生产经营主管部门审查同意, 经同级卫生行政部门审核批准, 发给《药品经营企业许可证》。药品生产经营主管部门和卫生行政部门应当在各自收到全部申报材料后的30日内, 作出是否同意或者批准的决定。
第十一条 《药品管理法》第四条、第十条、第二十二条所称＂药品生产经营主管部门＂, 是指县以上地方各级医药归口管理部门或者人民政府指定的部门。
第十二条 医疗单位自配制剂, 必须向所在省、自治区、直辖市卫生行政部门申请, 经审查批准后发给《制剂许可证》。受理审查的卫生行政部门应当在收到全部申报材料后30日内, 作出是否批准的决定。
第十三条 《药品生产企业许可证》，《药品经营企业许可证》，《制剂许可证》的有效期为5年。期满后继续生产，经营药品或者配制制剂的, 持证单位应当在期满前6个月重新申请, 重新申请的程序与第一次申请的程序相同。企业破产或者关闭, 上述许可证应当由原发证部门缴销。
第十四条 《药品生产企业许可证》，《药品经营企业许可证》，《制剂许可证》由国务院卫生行政部门统一印制。
第四章 新药的审批
第十五条 国家鼓励研究、创制新药, 凡有条件的药品研究单位、高等院校、药品生产企业，医疗单位或者个人都可以从事新药的研究、创制。
第十六条 新药审批办法由国务院卫生行政部门制定。
第十七条 新药配制单位申请进行新药临床试验, 必须按照新药审批办法的规定, 报送有关资料和样品。
第十八条 新药临床试验或者临床验证, 应当在省、自治区、直辖市卫生行政部门批准的医疗单位进行。
第十九条 完成临床试验或者临床验证并通过所在省、自治区、直辖市卫生行政部门初审的新药, 由研制单位报国务院卫生行政部门审批。经国务院卫生行政部门批准后, 发给新药证书。国务院卫生行政部门应当在收到全部申报材料后, 尽快组织药品审评委员会审评, 并在审评后的两个月以内, 作出是否批准的决定。
第二十条 国务院卫生行政部门和省、自治区、直辖市卫生行政部门可以成立药品审评委员会, 委员会成员由医疗、科研、生产、教学等方面的医学，药学专家组成。
第二十一条 对于新药研制单位或者个人提交的有关资料、数据、工艺等, 临床试验或者验证单位，审批部门及其工作人员应当承担保密责任。
第五章 药品的批准文号
第二十二条 生产新药由生产单位向国务院卫生行政部门提出申请, 经审核批准发给批准文号, 但生产中药饮片除外。生产已有国家标准或者省、自治区、直辖市标准的药品, 由生产单位向省、自治区、直辖市卫生行政部门提出申请。卫生行政部门应当在徽求同级药品生产经营主管部门的意见后, 决定是否发给批准文号, 但生产中药饮片除外。
第二十三条 药品生产企业申请批准文号, 应当向省、自治区、直辖市卫生行政部门指定的药品检验所送交检验样品和必要的资料, 药品检验所应当及时作出检验报告,送交负责审核的卫生行政部门。卫生行政部门在收到检验报告的30日内, 作出是否发给批准文号的决定。
第二十四条 药品的批准文号在5年内不得变更, 但停产3年以上的药品, 其批准文号作废。
第二十五条 国务院卫生行政部门对于已经批准生产的药品, 应当组织调查; 经药品审评委员会评价后, 对疗效不确、不良反应大或者其他原因危害人民健康的药品, 应当撤销其批准文号。
第六章 药品生产企业的管理
第二十六条 国家推行《药品生产质量管理规范》。国务院行政部门制定《药品生产质量管理规范》并监督执行; 药品生产经营主管部门可以根据《药品生产质量管理规范》的要求, 制定实施规划, 指导《药品生产质量管理规范》的逐步实施。
第二十七条 新建药品生产企业和现有企业的扩建、改建部分必须符合《药品生产质量管理规范》的要求。现有企业应当按照《药品生产质量管理规范》的要求, 制定和执行保证药品质量的规章制度和卫生要求, 并逐步有计划地达到《药品生产质量管理规范》的要求。
第二十八条 药品生产企业应当具有专职技术人员及技术工人, 并符合下列条件:(一)负责药品生产技术和质量的厂长必须熟悉药品生产业务知识;(二)药品生产技术和质量检验机构的负责人, 根据生产品种的不同, 应当分别由相应的药师、助理工程师、中药师以上的技术人员担任;(三)车间技术负责人须具有中专以上文化程度, 并有5年以上的生产实践经验;(四)生产技术工人应当经过本生产工序的技术培训, 未经过培训的不得单独操作; (五)中药饮片加工企业不能达到第(二)项要求的，必须配备熟悉药性、能够鉴别药材的真伪优劣，掌握生产技术并经县级以上卫生行政部门审查登记的药工人员。
第二十九条 药品生产企业必须具有能够保证药品质量的厂房，设施和卫生环境, 并保持整洁。配制输液剂、粉针剂的，必须具备超净条件。
第三十条 药品生产企业必须具有能对所生产药品进行质量检验的独立机构和人员, 具有相适应的仪器和设备。
第三十一条 中药厂(包括西药厂生产中药的车间)除依照本办法第二十八条、第二十九条、第三十条、第三十二条规定执行外, 还应当做到: (一)按照规定对不同的原药材进行挑捡、整理、洗净、烘干、炮制等预处理; (二)生产中药制剂的工序(配料、粉碎、内包装等)不得在有可能污染药品的环境下进行; (三)西药厂生产中药制剂, 应当配备中药技术人员负责质量管理。
第三十二条 药品生产企业生产的各种药品, 必须按照原核定的药品标准和工艺规程进行生产, 如果改变药品生产工艺规程可能影响药品标准时, 须报省、自治区、直辖市卫生行政部门审核批准后方可进行。
第三十三条 药品生产企业应当有完整的生产记录和检验记录。记录保存至该批药品的有效期满后1年; 无有效期的, 保存3年。
第三十四条 生产药品所需的原料、辅料以及直接接触药品的容器和包装材料, 应符合国家药典或其他药用要求。使用没有上述要求的物品, 应当向当地卫生行政部门备案。
第三十五条 药品生产企业应当加强质量管理, 药品出厂前必须经过本企业药品检验机构的质量检验, 符合标准的, 应当在内包装内附有合格标志或者化验报告; 不符合标准的, 不得出厂。
第七章 药品经营企业的管理
第三十六条 药品经营企业应当具有专职的药学技术人员, 并符合下列条件:(一)药品批发企业设置质量检验机构, 由中药士、药剂士以上的技术人员负责;(二)药品零售企业应当配备中药士、药剂士以上的技术人员, 或者应当配备经县经以上卫生行政部门审查登记的专职药工人员;(三)新招聘和调入的从事药品调剂、收购、保管、销售的非药学技术人员, 须经过本企业的药学知识培训, 未经过培训的不得单独工作。
第三十七条 药品经营企业的营业场所、设备、仓储设施和卫生环境应当符合下列要求:(一)药品的存放和保管必须符合各类药品的理化性能要求。应有防尘、防潮、防污染、防虫蛀、防鼠咬、防霉变的措施。需要避光、低温贮藏的药品,应当有适宜的专库(柜)保存;(二)药品经营企业兼营非药品的, 必须另设兼营商品专柜, 不得与药品混放。
第三十八条 药品经营企业除中药的饮片加工、炮制和按照处方代患者调配制剂外, 不得自制成药出售。
第三十九条 药品经营企业收购、销售药品必须建立健全严格的质量检验和入库验收、在库保养、出库验发等制度。
第四十条 收购药品, 必须进行检查验收。检查验收内容包括: 药品的品名、生产企业、生产批号、合格证、批准文号、注册商标、包装以及药品的外观质量等。对中药材必须检查包装, 每件包装上必须注明品名、产地、调出单位，并附有质量合格标志。
第八章 医疗单位的药剂管理
第四十一条 配制制剂的医疗单位必须具备下列条件:(一)县级以上医院(包括100张病床以上的厂矿企事业医疗单位)的制剂，药检业务负责人, 须由药师以上的技术人员担任;县级以下医院的制剂, 药检业务负责人, 须由药剂士以上的技术人员担任;(二)制剂场所应当具有能够保证药品质量的房屋和设备, 并保持整洁。灭菌制剂室要具备更衣、缓冲、洗涤、配制、灌封、灭菌、包装等适宜的条件和空调等设施。配制输液剂的, 必须具备超净条件。
第四十二条 配制制剂要严格执行操作规程、质量检验和卫生制度。每批制剂必须有详细完整的记录。
第四十三条 配制制剂的医疗单位须有相应的药检室。经检验质量合格的制剂, 由药检室签发制剂合格证, 凭医生处方使用; 不合格的, 不准供临床使用。
第四十四条 医疗单位配制的制剂, 只限于本单位临床和科研需要而市场上无供应或供应不足的药物制剂。医疗单位配制的制剂, 不得在市场销售或者变相销售。
第四十五条 医疗单位配制制剂, 必须按照省、自治区、直辖市卫生行政部门制定的医院制剂规范配制, 并向所在地的卫生行政部门备案。
第四十六条 医疗单位除药剂科(室)、同位素室(核医学室)可以配制、供应药品外, 其他科室均不得配制、供应药品。
第九章 处罚
第四十七条 除违反《药品管理法》第十五条、第八章有关广告管理的规定的行政处罚, 由工商行政管理部门决定外, 《药品管理法》和本办法规定的行政处罚，由县级以上卫生行政部门决定，并出具书面处罚通知。对假药、劣药的处罚通知应当载明药品检验所的质量检验结果。
罚款所得全部上交国库。
第四十八条 对生产、销售、使用假药的, 没收假药和违法所得, 卫生行政部门根据情节，可处以该批假药冒充正品价格的5倍以下的罚款。
第四十九条 对生产、销售、使用劣药的, 没收劣药和违法所得, 卫生行政部门根据情节，可处以该批劣药相当正品价格的3倍以下的罚款。
第五十条 生产、销售、使用假药、劣药, 有下列情形之一的, 视为情节严重, 卫生行政部门应当从重给予行政处罚:(一)以麻醉药品、精神药品、毒性药品、放射性药品冒充其他药品, 或者以其他药品冒充上述药品的;(二)生产、销售的假药、劣药以婴幼儿为主要使用对象的;(三)生产、 销售、使用假药、劣药已造成人员伤害后果的;(四)生产、销售、使用假药、劣药, 经处理后重犯的;(五)国家其他法律、法规规定应当从重处罚的。
第五十一条 对未取得《药品生产企业许可证》，《药品经营企业许可证》，《制剂许可证》而生产、经营药品或者配制制剂的, 卫生行政部门除责令其立即停产、停业、停止配制制剂外, 没收全部药品和违法所得, 并根据情节, 处以其所生产、经营药品或配制制剂正品价格的5倍以下的罚款。
第五十二条 对有下列情形之一的单位或者个人, 卫生行政部门可以根据情节处以警告, 或者并处2万元以下的罚款:(一)首次进口的药品未经国务院卫生行政部门批准的;(二)进口的药品未经国境口岸药品检验所检验的;(三)擅自进行新药临床试验或验证的;(四)未经卫生行政部门批准, 擅自改变生产工艺规程, 致使药品标准发生改变的;(五)医疗单位自制制剂在市场销售或者变相销售的。
第五十三条 对有下列情形之一的单位或者个人, 卫生行政部门可以根据情节处以警告, 或者并处1万元以下的罚款:(一)应当注明有效期的药品未注明有效期的;(二)违反药品包装或者违反发运中药材包装规定的;(三)药品包装未按照规定贴印标签或者标签、说明书内容不符合规定的;(四)擅自收购、销售未经审核批准的新发现或者从国外引种的中药材的。
第五十四条 药品检验所工作人员和药品监督员利用职权徇私舞弊、收受贿赂, 情节轻微的, 由卫生行政部门给予行政处分; 情节严重构成犯罪的, 依法追究刑事责任。
第十章 附 则
第五十五条 麻醉药品，精神药品，毒性药品，放射性药品和外用药品的标签, 规定如下(见附图--见中华人民共和国涉外法规汇编(1949-1990)第三册第1505页)。
第五十六条 本办法由国务院卫生行政部门负责解释。
第五十七条 本办法自发布之日起施行。
【名称】 MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRA-TION LAW OF THE PEOPLE^S REPUBLIC OF CHINA
【题注】
Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE^S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People^s Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole document (法规全文)
MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRA-
TION LAW OF THE PEOPLE^S REPUBLIC OF CHINA
(Approved by the State Council on January 7, 1989 and promulgated
by the Ministry of Public Health by Decree No. 1 on February 27, 1989)

Chapter I General Provisions
Article 1
These Measures are formulated in accordance with the Pharmaceutical
Administration Law of the People^s Republic of China (hereinafter referred
to as Pharmaceutical Administration Law).
Article 2
These Measures are applicable to any units or individuals who are related
to the production, selling, using, testing and examination or scientific
research of medicines. These Measures are also applicable to the
pharmaceutical enterprises in the People^s Liberation Army that are
engaged in the production of medicines for civilian use.
Article 3
In the production and selling of pharmaceuticals, social benefit shall be
taken as the prime concern. The production, selling or use of fake or
inferior medicines is strictly prohibited.
Without authorization no production or sales of pharmaceuticals or
preparation of medicaments shall be allowed.

Chapter II Responsibility for the Supervision and Administration of Pharmaceuticals
Article 4
The administrative department of health under the State Council is in
charge of the nationwide supervision over and administration of
pharmaceuticals. Its principal responsibilities are as follows:
(1) to enforce the pharmaceutical Administration Law and these Measures;
(2) to draft laws and regulations related to the supervision and
administration of pharmaceuticals, and to formulate provisions for the
implementation of each law or regulations;
(3) to promulgate the Pharmacopoeia of China and the national standards
for medicines;
(4) to examine and approve new medicines and to verify and issue approval
certificates thereof;
(5) to exercise supervision over the production, trading and use of
pharmaceuticals;
(6) to make investigation and appraisal of the curative effect and side
effect of the medicines already put into production and to provide and
publish information related to the quality;
(7) to make decisions on disciplinary sanctions in accordance with the
pharmaceutical Administration Law and these Measures.
Pharmaceutical administration organs in the administrative departments of
health at or above the county level are in charge of the supervision over
and administration of pharmaceuticals within their respective
jurisdiction.
Article 5
The medicine inspection organs set up by the administrative departments of
health at or above the county level shall, under the latter^s leadership,
conduct medicine inspection in accordance with the standards for medicines
set by the state and by the administrative department of health at the
level of province, autonomous region or municipality directly under the
Central Government.
Article 6
Medicine supervisor(s) shall be appointed in the administrative department
of health at or above the county level. Medicine supervisors at the state
level shall be entrusted by the administrative department of health under
the State Council by credentials. Medicine supervisors at the provincial,
autonomous region or municipal government (directly under the Central
Government) level and at the autonomous prefecture, municipality or county
level shall be nominated respectively by the administrative departments of
health and entrusted with credentials by the people^s governments at the
corresponding levels. The duties of medicine supervisors at all levels
shall be defined separately by the administrative department of health
under the State Council.

Article 7
When carrying out their duties, the medicine supervisors are required to
present their credentials before they take sample testing and ask for
relevant technical data, with a receipt in accordance with the state
stipulations. They are required to keep confidential the technical data
provided by the production enterprise and scientific research unit. The
medicine supervisors may temporarily seal up some medicine pending further
settlement. It is required of them to state the term of sealing up which
shall not normally exceed 15 days.

Chapter III Procedure for the Verification and Approval of Li- censes
Article 8
The procedures for examination and approval as stipulated in Paragraph 1
of Article 4 of the Pharmaceutical Administration Law denote that the
establishment of a pharmaceutical producing enterprise (including all
forms of inland associated enterprises, Chinese-foreign equity joint
ventures and contractual joint ventures and foreign invested enterprises)
shall involve, in addition to applying for approval for the capital
construction of the enterprise in accordance with state stipulation, the
following steps: (1) the enterprise or its leadership organ submits an
application to the competent department for the production and trading of
pharmaceuticals of the province, autonomous region or municipality
directly under the Central Government where the enterprise is located for
examination and approval and then refer it to the administrative
department of health at the same level. (2) upon approval by the
administrative department of health of the province, autonomous region or
municipality directly under the Central Government, a Pharmaceutical
Producer License shall be issued. The department in charge of the
production and trading of pharmaceuticals and the administrative
department of health are required to make a decision within 30 days of
receipt of complete application materials.
Article 9
If a pharmaceutical production enterprise desires to set up a branch
factory or any additional workshops outside the premise of the factory, it
is required to submit an application to the department in charge of the
production and trading of pharmaceuticals at the level of the province,
autonomous region or municipality directly under the Central Government
for examination and approval and then refer it to the administrative
department of health at the same level for a Pharmaceutical Producers
License, on which the status of the new set-up (a branch factory or a
workshop) and its production scope must be clearly stated.

Article 10
The procedures for examination and approval stipulated in Paragraph 1 of
Article 10 of the Pharmaceutical Administration Law denote that a
pharmaceutical trading enterprise (including specialized and non-
specialized whole-sale or retail drug stores or companies) should apply
for a Pharmaceutical Trading Enterprise License in accordance with the
following provisions:
(1) for a wholesale drug enterprise, an application must be submitted to
the department in charge of the production and trading of pharmaceuticals
at the level of the province, autonomous region or municipality directly
under the Central Government for examination and approval and then be
referred to the administrative department of health at the same government
level for verification and approval before a Pharmaceutical Trading
Enterprise License is issued;
(2) for a retail drug enterprise, an application must be submitted to the
department in charge of the production and trading of pharmaceuticals at
the autonomous prefecture, municipality or county government level for
examination and approval and then be referred to the administrative
department of health at the same government level for verification and
approval before a Pharmaceutical Trading Enterprise License is issued.
The department in charge of the production and trading of pharmaceuticals
and the administrative department of health are required to make a
decision within 30 days of receipt of complete application materials.
Article 11
The competent department for the production and trading of pharmaceuticals
stated in Articles 4, 10 and 22 of the Pharmaceutical Administration Law
refers to those pharmaceutical administration organs or departments
appointed by the people^s government at or above the county level.

Article 12
If a medical treatment unit needs to prepare some medicaments, it is
required to submit an application to an administrative department of
health at the level of the province, autonomous region or municipality
directly under the Central Government for examination and approval before
a Dispensing Permit is granted.
The administrative department of health is required to make a decision
within 30 days of receipt of complete application materials.
Article 13
The term of validity for a Pharmaceutical Producer Licence, a
Pharmaceutical Trading Enterprise Licence, or a Dispensing Permit is 5
years. If the licensee wishes to continue its production or trading or
making medicament preparation upon expiration of the licence, it must
reapply for permission. The entire application procedures must be
repeated.
If an enterprise has gone bankrupt or has wound up business, the license
it is holding should be cancelled by the administrative department of
health that has issued it.
Article 14
Pharmaceutical Producer Licence, Pharmaceutical Trading Enterprise
Licence, and Dispensing Permit shall be printed exclusively by the
administrative department of health under the State Council.

Chapter IV Examination and Approval of New Medicines
Article 15
The state encourages research in and development of new medicines. All
pharmaceutical research units, medical colleges, pharmaceutical production
enterprises, medical treatment units or individuals with the necessary
conditions are encouraged to engage in the research in and development of
new medicines.
Article 16
Procedures for the examination and approval of new medicines shall be
formulated by the administrative department of health under the State
Council.
Article 17
Before a new medicine is put to clinical testing, the research and
development unit of this medicine is required to submit an application
together with the relevant data and samples in accordance with the
provisions for the examination and approval of new medicines.
Article 18
Clinical testing or clinical verification of a newly developed medicine
must be conducted in the medical treatment unit(s) approved by the
administrative department of health at the level of the province,
autonomous region or municipality directly under the Central Government.
Article 19
After new medicines have been clinically tested and verified and have
passed the primary examination by the administrative departments of health
at the level of the province, autonomous region or municipality directly
under the Central Government, the research and development unit of these
new medicines shall submit an application to the administrative department
of health under the State Council for examination and approval and New
Medicine Certificates shall be issued accordingly.
The administrative department of health under the State Council is
required to call, at the earliest possible time, the Medicine Appraisal
Committee to make technical appraisal of the newly developed medicine
after the complete application materials are received. A decision must be
made within two months of the technical appraisal.
Article 20
The administrative department of health under the State Council and those
in the provinces, autonomous regions or municipalities directly under the
Central Government may set up a Medicine Appraisal Committee which is
composed of experts in medical science and pharmacology from medical
treatment units, scientific research units, pharmaceutical factories and
medical colleges.

Article 21
The clinical testing or clinical verification unit, the department to
examine and approve the newly developed medicine and individuals so
involved are required to keep confidential the relevant data, figures,
production techniques provided by a unit or individual that has developed
the new medicine.

Chapter V Registered document of Approval for Medicines
Article 22
For the production of a new medicine, the production unit shall submit an
application to the administrative department of health under the State
Council for examination and approval upon which a Registered document of
Approval shall be issued to the unit. However, this does not apply to the
production of traditional Chinese medicine in ready-to-use forms.
To produce a certain kind of medicine for which the state, the province,
autonomous region or municipality directly under the Central Government
has already set standards, the production unit is required to submit an
application to the administrative department of health at the level of the
province, autonomous region or municipality directly under the Central
Government. After consulting the department in charge of the production
and trading of pharmaceuticals at the same level, the administrative
department of health shall make a decision on whether to issue the
Registered document of Approval to the unit. However, this does not apply
to the production of traditional Chinese medicine in ready-to-use forms.
Article 23
When applying for a Registered document of Approval for a medicine, the
production unit must present testing samples and relevant data to the
medicine inspection organ appointed by the administrative department of
health at the level of the province, autonomous region or municipality
directly under the Central Government. The medicine inspection organ is
required to make a test report and refer it to the administrative
department of health for examination and approval, which shall, within 30
days of receipt of the test report, make a decision on whether to issue
the Registered document of Approval to the unit.
Article 24
The Registered document of Approval for a medicine is valid for 5 years,
during which time no change of the registration number shall be allowed.
The Registered document of Approval of a medicine shall become invalid if
the medicine has not been produced for 3 years.
Article 25
The administrative department of health under the State Council is
required to organize investigations of medicines that have been approved
for production. The Medicine Appraisal shall revoke the Registered
document of Approval if it discovers by appraisal that the medicine^s
curative effects are uncertain, that they produce serious adverse
reactions, or that for other reasons they are harmful to people^s health.

Chapter VI Administration of Pharmaceutical Production Enterprises
Article 26
The state shall practise The Norms For Quality Control of Medicine
Production. The administrative department of health under the State
Council shall formulate The Norms For Quality Control of Medicine
Production and supervise the implementation thereof. The departments in
charge of the production and trading of medicines may formulate specific
rules to guide the gradual implementation of the Norms.
Article 27
All the newly built pharmaceutical factories and the extension or rebuilt
workshops of the existing pharmaceutical factories are required to meet
the requirements stipulated in the Norms For Quality Control of Medicine
Production. The existing pharmaceutical enterprises are required to
establish hygiene rules and regulations to ensure medicine quality and
strive to meet all the requirements stipulated in the Norms For Quality
Control of Medicine Production gradually and in a planned way.
Article 28
Pharmaceutical production enterprises shall be staffed with professional
technical personnel and skilled workers who must meet the following
qualifications:
(1) a factory manager in charge of pharmaceutical production and quality
control must be familiar with the techniques involved in pharmaceutical
production;
(2) the post of the director in charge of pharmaceutical production
technology and quality inspection shall be held respectively by a
pharmaceutist, an assistant engineer or a herbdruggist, depending on the
kind of medicine being produced;
(3) the responsible workshop technician is required to have an education
of at least the technical school level and with 5 years or more production
experience;
(4) the technical workers are required to go through technical training
before they are allowed to operate independently;
(5) with respect to those pharmaceutical factories processing traditional
Chinese medicines into ready-to-use forms, if they are unable to meet the
requirements stated in Item 2 of Article 28 of these Measures, the
relevant posts shall be held by Chinese medicinal herb personnel who are
familiar with the properties of the herbal medicine processed, can
appraise medicinal herbs and have a mastery of the production techniques.
These personnel must be examined by and registered with the administrative
department of health above county level.
Article 29
Pharmaceutical enterprises are required to have factory premises,
facilities and a sanitary environment to ensure the quality of the
medicine. They must be kept clean and tidy. If they are engaged in the
preparation of transfusion medicament and powdered injection, they must
have ultra clean conditions and superclean environment.

Article 30
Pharmaceutical enterprises are required to have their own quality
inspection organ and personnel, as well as necessary instrument and
equipment to ensure the quality of their products.
Article 31
Traditional Chinese medicine factories (including those traditional
Chinese medicine workshops in Western medicine factories) must not only
meet the requirements stipulated in Articles 28, 29, 30 and 32 of these
Measures but also abide by the following stipu-lations:
(1) Raw medicinal herbs must be pretreated by way of picking, sorting,
washing and baking according to the relevant requirements.
(2) See to it that the processing of traditional Chinese medicine into
ready-to-use forms (including batching, grinding and packaging) shall be
done in an environment free from contamination.
(3) Traditional Chinese medicine technical personnel shall be put in
charge of quality control of the Chinese medicine produced in the Western
medicine factories.
Article 32
Medicines must be made in accordance with the verified standards and
through the fixed technical processes. If a pharmaceutical factory intends
to make any change in the production technique which may affect the
quality of the medicine, it is required to submit an application to the
administrative department of health at the level of the province,
autonomous region or municipality directly under the Central Government
for examination and approval.
Article 33
Pharmaceutical enterprises are required to have a complete production
record and lab testing record on file. These records shall be kept for one
year after the expiry date of the recorded batch of medicine. With respect
to medicines without expiry dates, their records shall be kept for 3
years.
Article 34
It is required that all raw materials and additives needed in the
production of medicines, the containers and packaging material that may
directly contact the medicine must meet the requirements of the state
pharmacopoeia or other pharmaceutical standards. Pharmaceutical factories
that plan to use other kinds of materials are required to report their
plans to the administrative department of health for the record.
Article 35
Pharmaceutical enterprises must strengthen medicine quality control. All
kinds of medicines are subject to quality inspection by their own medicine
inspection organs before leaving the production premises. A quality tag or
lab testing report shall be put in the interior package of quality
products. Those medicines that fail to pass the quality inspection shall
not be allowed to leave the production premises.

Chapter VII Administration of Pharmaceutical Trading Enterprises
Article 36
Pharmaceutical trading enterprises shall be staffed with full time
pharmaceutical technical personnel who must meet the following
qualifications:
(1) A wholesale pharmaceutical trading enterprise shall set up quality
inspection organs which shall be put under the charge of professional
pharmacists of Chinese or Western medicine.
(2) A retail pharmaceutical trading enterprise shall be staffed with a
pharmacist or a Chinese medicine pharmacist or a full time pharmaceutical
staff worker who has been examined and registered by the administrative
department of health at or above county level.
(3) Non-pharmaceutical workers newly recruited or staffed to engage in
pharmaceutical preparation, purchasing, storage keeping or marketing of
medicines are required to go through professional training before they are
allowed to work independently.
Article 37
The business premises, facilities, storage facility and clean environment
of a pharmaceutical trading enterprise must meet the following
requirements:
(1) The storage facilities must meet the requirements by the physical
properties and chemical characters of medicines. The storage must be well
equipped against dust, rats and deterioration. For those medicines which
need to be kept away from light and in low temperature, there must be
light lock and thermal protective storage devices.
(2) A pharmaceutical trading enterprise that also deals in other
merchandise is required to install separate counters for these
merchandise. No medley of medicine and other articles in the same counter
shall be allowed.
Article 38
Pharmaceutical trading enterprises may prepare or process Chinese medicine
(including slicing, roasting, baking, shimmering, etc.) or make up
prescriptions for patients. However, they may not make any ready-for-use
Chinese medicine for sale.
Article 39
Pharmaceutical trading enterprises are required to establish a strict
quality checking system and a storage system which includes stock checking
in and out and stock protection.
Article 40
Pharmaceutical trading enterprises must examine carefully the stock of
medicine prior to its purchase. The items for examination shall include
its name, producer^s name, batch number, quality certificate, registered
document (number) of approval, registered trade mark, packing and exterior
quality. With respect to Chinese medicinal materials, it is required to
examine the packing which must include its name, place of origin, name of
consignor and quality inspection mark.

Chapter VIII Administration of Medicaments Prepared by Medical Treatment Units
Article 41
Medical treatment units that prepare their own medicaments shall meet the
following requirements:
(1) the post in charge of medicament preparation and inspection in
hospitals at or above the county level (including these medical treatment
units with more than 100 wardbeds in factories, mines, enterprises or
institutions) shall be held by a person who bears at least the title of
senior pharmacist.
Such a post in a hospital under the county level must be held by a person
who bears at least the title of pharmacist.
(2) preparation of medicaments must be made in a proper building with
adequate facilities and in clean and tidy environment. Places for
preparation of sterilized medicaments must have a locker room, buffer
room, wash room, preparation room, filling and sealing room, sterilization
room, packing room and air-conditioning. Places for preparation of
infusion and transfusion medicaments are required to have superclean
conditions.
Article 42
In preparing medicaments, it is required to strictly abide by the
operating rules, quality inspection rules and hygiene rules. It is
required to have detailed and complete records for the preparation of each
batch of medicament.
Article 43
The medical treatment units that prepare their own medicaments are
required to have appropriate medicament inspection labs.
The medicine inspection lab shall sign and issue a quality certificate for
those medicaments that have passed the inspection and may be adopted for
clinical application. Rejects shall not be allowed for clinical use.
Article 44
Medical treatment units may prepare only those medicaments that are to be
used clinically or in research by themselves and that are not available on
the market or insufficiently supplied. These medicaments may not go to the
market or do so in a devious manner.
Article 45
Medical treatment units are required to prepare their medicaments for
clinical use in conformity with the norms for the preparation of clinical
medicaments stipulated by the administrative department of health at the
level of the province, autonomous region or municipality directly under
the Central Government and report to the local administrative department
of health for the record.

Article 46
In medical treatment units, no divisions shall be allowed to prepare and
supply clinical medicaments except the division of pharmacy and the
division of radioisotope.

Chapter IX Penalty Provisions
Article 47
Violation of Article 15 of the Pharmaceutical Administration Law and
violation of Chapter VIII of the same law related to the administration of
advertisements shall have disciplinary sanctions imposed by the
administration department for industry and commerce; violation of the
Pharmaceutical Administration Law and these Measures shall have
disciplinary sanctions imposed by the administrative department of health
at or above county level with a written penalty notice. It is required to
state a quality inspection result on a penalty notice for fake medicine
and medicine of inferior quality. All the forfeit shall be turned in to
the national treasury.
Article 48
Those who make or sell or use fake medicine shall have their fake
medicines and illegal gains confiscated. The administrative department of
health shall impose a maximum fine five times or less the price of the
standard medicine which the fake equivalent is used to pass off for
according to the seriousness of the case.
Article 49
Those who make or sell or use medicine of inferior quality shall have
their inferior medicine and illegal gains confiscated. The administrative
department of health shall impose a maximum fine three times or less the
price of the standard medicine which the inferior equivalent is used to
pass off for according to the seriousness of the case.
Article 50
Any one of the following acts of making, selling or using fake or inferior
medicines shall be considered as a serious case on which the
administrative department of health shall impose severe disciplinary
sanctions:
1. a counterfeit of other medicine with narcotics, psychotropic
substances, toxic drugs or radioactive drug or vice versa;
2. an act of making or selling fake medicine or inferior medicine to be
mainly administered to babies or infants;
3. an act of making, selling or using fake or inferior medicine which has
produced harmful results as to endanger people^s health;
4. repetition of an act of making, selling or using fake or inferior
medicine after being penalized;
5. any act that shall be imposed with severe punishment as stipulated in
other state laws and regulations.
Article 51
Any units engaged in the production, trading or preparation of medicines
without obtaining the Pharmaceutical Producer Licence, Pharmaceutical
trading Enterprise Licence or Dispensing Permit shall be ordered to
suspend production, business operations or preparation of such medicines.
The medicines and the illegal gains therefrom shall all be confiscated and
the administrative department of health may impose a maximum fine five
times the price of the standard medicine or medicament, according to the
seriousness of the case.

Article 52
Units or individuals that have committed any of the following violations
shall be given a disciplinary warning or penalized with a maximum fine of
20,000 RMB yuan according to the seriousness of the case:
1. to import medicines from abroad for the first time without approval by
the administrative department of health under the State Council;
2. to import medicines from abroad without inspection by the medicine
inspection organ at the border port;
3. to conduct clinical testing or verification of new medicine without
authorization;
4. to change the technological process of production without approval by
the administrative department of health and, as a result, the quality of
the medicine has been degraded;
5. to prepare medicaments for sale or for sale in devious manner by
medical treatment units.
Article 53
Any unit or individual that has committed any one of the following acts
shall be given a disciplinary warning or penalized with a maximum fine of
10,000 RMB yuan according to the seriousness of the case:
1. fail to indicate the expiry date of the medicine which ought to be
indicated;
2. violate the regulations concerning inner packaging of Chinese medicinal
materials or protective packaging of pharmaceuticals for shipment;
3. fail to label the packing as required or the items printed on the label
or on the package insert are not in conformity with the requirements;
4. to purchase or sell newly discovered Chinese medicinal materials or
those introduced from abroad that have not been examined and approved.
Article 54
Any individual at the medicine inspection organs or any medicine
supervisor who abuses his power or engages in malpractices for personal
gains shall be given a disciplinary sanction by the administrative
department if the offence is not very serious; if the case is serious as
to constitute a crime, he shall be prosecuted for criminal responsibility
according to law.

Chapter X Supplementary Provisions
Article 55
Labels for narcotics, psychotropic substances, toxic drugs, radioactive
drugs and medicines for external application shall be designed as follows
(See the attached drawings [*1]).
Article 56
The right to interpret these Measures resides in the administrative
department of health
Article 57
These Measures shall go into effect as of the date of promulgation.
Note:
[*1] The attached drawings see page 1505. -The Editor

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