Commissioner of SFDA


Provisions for Drug Insert Sheets and Labels



(SFDA Decree No.24)

The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006.


Shao Mingli
Commissioner of SFDA

March 15, 2006





Provisions for Drug Insert Sheets and Labels


Chapter I General Provisions

Article 1 The Provisions are enacted with a view to regulating drug insert sheets and labels in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.

Article 2 The insert sheets and labels of drugs marketed within the territory of the People’s Republic of China shall meet the requirements of the Provisions.

Article 3 Drug insert sheets and labels shall be reviewed and approved by the State Food and Drug Administration.

A drug shall be labeled on the basis of its insert sheet. The content of the label shall be within the scope of the insert sheet. Any words and marks with implied therapeutic effects, misleading information on usage, or inappropriate promotion of the product shall not be printed.

Article 4 A drug label shall be printed on or affixed to the drug package, and no other written words, audio and/or visual materials or other information are attached to introduce or publicize the product or the enterprise.

An insert sheet shall be attached to the smallest package provided by the drug manufacturer for marketing.

Article 5 The wording in drug insert sheets and labels shall be scientific, standardized and accurate. The insert sheet of a non-prescription drug shall be written intelligibly and convenient for patients to judge, choose and use the drug on their own.

Article 6 In the label or insert sheet, the letters or characters shall be clear and easy to be recognized and the marks shall be clear and distinctive. The label and insert sheet shall have no print faded and shall not be affixed unsteadily. Any addition or modification shall not be made by means of pasting, cutting or altering.

Article 7 Drug insert sheets and labels shall be written in standardized Chinese characters published by the National Language Commission. The versions in other languages shall comply with the Chinese version.

Article 8 With the aim to protect public health and direct the rational use of drugs, drug manufacturers may voluntarily apply to add warnings to drug insert sheets or labels. The State Food and Drug Administration may also request drug manufacturers to add warnings to drug insert sheets or labels.


Chapter II Drug Insert Sheet

Article 9 A drug insert sheet shall include the significant scientific data, conclusions and information concerning drug safety and efficacy in order to direct the safe and rational use of drugs. The specific format, content and writing requirements of drug insert sheet shall be prescribed and issued by the State Food and Drug Administration.

Article 10 Disease names, pharmaceutical terms, drug names, the names and results of clinical testing in drug insert sheets shall be expressed in professional terms published or standardized by the State. The units of measurement shall conform to the national standards.

Article 11 All the active ingredients or medicinal ingredients of traditional Chinese medicines in a prescription shall be listed in the insert sheet. For injections and non-prescription drugs, all excipients shall be listed as well.

The ingredients or excipients included in a prescription, which may cause severe adverse reaction, shall be specified.

Article 12 A drug manufacturer shall trace the safety and efficacy of its marketed drugs. For any modification to the insert sheet, an application shall be submitted timely.

The State Food and Drug Administration may also require a drug manufacturer to make modification to the insert sheet on the basis of the results of adverse drug reaction monitoring and drug re-evaluation.

Article 13 After the modification to the insert sheet is approved, the drug manufacturer shall inform relevant drug distributors, drug users and other departments of the modified content immediately, and use the modified insert sheet and label timely as required.

Article 14 The insert sheet shall provide full information on adverse drug reaction and indicate the adverse reactions in detail. A drug manufacturer, who fails to timely modify the insert sheet on the basis of the safety and efficacy data of the marketed drug or to fully explain the adverse reaction in the insert sheet, shall be liable for all the consequences arising therefrom.

Article 15 The approval date and the modification date shall be distinctively shown in the insert sheet.


Chapter III Drug Labels

Article 16 Drug labels refer to the information printed or pasted on drug packaging, including inner labels and outer labels. Inner labels refer to those that appear on immediate packaging; outer labels are those on the other packaging outside of inner labels.

Article 17 The inner label shall bear such drug information as the adopted name in China, indications or functions, strength, dose and usage, production date, batch number, expiry date and manufacturer. If there is no enough space in the package to include all the information mentioned above, the adopted name in China, strength, batch number and expiry date shall be indicated at least.

Article 18 The outer label of a drug shall indicate such information as the adopted name in China, ingredients, description, indications or functions, strength, dose and usage, adverse reactions, contraindications, precautions, storage, production date, batch number, expiry date, approval number and manufacturer. Where indications or functions, dose and usage, adverse reactions, contraindications and precautions cannot be fully noted, main information plus a “See drug insert sheet for details.” notice shall be indicated.

Article 19 The label on the package for transportation and storage shall bear at least the adopted name in China, strength, storage, production date, batch number, expiry date, approval number and manufacturer. Other information such as packaging quantity, precautions for transportation or other marks may be included when necessary.

Article 20 The label for drug substance shall include the adopted name in China, storage, production date, batch number, expiry date, applied specifications, approval number and manufacturer. Other necessary information such as packaging quantity and precautions for transportation shall also be indicated.

Article 21 Where one drug produced by a manufacturer has the same drug strength and packaging specification, the content, format and color of its labels must be the same. Where one drug produced by a manufacturer has different drug strengths or packaging specifications, its labels shall be clearly distinguished from one another, or its specifications shall be notably marked in the corresponding specification items.

Where a drug produced by a manufacturer is administrated as prescription drug and non-prescription drug respectively, their packaging colors shall be distinctly different.

Article 22 For drugs with special requirements on storage, its requirements shall be marked in the notable place of the label.

Article 23 The expiry date in the drug label shall appear in the order of year, month and day, with year shown in four digits, month and day in two digits. Its specific format shall be “Valid till XXXX year XX month” or “Valid till XXXX year XX month XX day”. It may be presented with numbers and other symbols as “Valid till XXXX.XX.” or “Valid till XXXX/XX/XX”.

For the preventive biological product, the expiry date shall be labeled according to the registration specifications approved by the State Food and Drug Administration. The expiry date of the biological product for therapeutic use shall be counted from the filling date. For other drugs, the expiry date shall be counted from the production date.

Where the expiry date is labeled to the day, it shall be marked as one day earlier than the actual expiry date; where the expiry date is labeled to the month, it shall be marked as one month earlier than the actual expiry month.


Chapter IV Use of Drug Name and Registered Trademark

Article 24 The drug name in insert sheets and labels shall conform to the nomenclature principles on the adopted name in China and trade name of drug announced by the State Food and Drug Administration, and shall be consistent with those appeared in the approval documents of the drug.

Article 25 The adopted name in China shall be conspicuous and prominent, and its typeface, size and color shall be consistent, and meet the following requirements:
(1) For horizontal labels, the adopted name in China shall appear in a prominent position within the area of the upper one-third of the label; for vertical labels, it shall appear in a prominent position within the area of the right one-third of the label;
(2) No such illegible typefaces as cursive characters and seal characters shall be used, and no such format as italics, margining and shading shall be used to modify the typefaces.
(3) The font color of the adopted name in China shall be black or white, in sharp contrast to the light-colored or dark-colored background respectively.
(4) Writing in separate lines shall be avoided unless limited by the packaging size.

Article 26 The trade name of a drug shall not be placed in the same line with the adopted name in China; its typeface and color shall be no more conspicuous than that of the adopted name in China, and its font area per character shall be no bigger than half of that of the adopted name in China.

Article 27 Unregistered trademarks and other drug names unapproved by the State Food and Drug Administration shall not be used in the drug insert sheets and labels.

Where a registered trademark is used in a drug label, it shall be printed in a corner of the label. Where a registered trademark contains characters, the font area per character shall be no bigger than a quarter of that of the adopted name in China.


Chapter V Other Provisions

Article 28 For narcotic drugs, psychotropic substances, medicinal toxic drugs, radioactive pharmaceuticals, drugs for topical use, non-prescription drugs and other drugs having special marks specified by the State, their special marks shall be printed in the drug insert sheets and labels.
Where there are special provisions issued by the State for drug insert sheets and labels, they shall prevail.

Article 29 The labeling provisions for Chinese crude drugs and prepared slices of Chinese crude drugs shall be formulated separately by the State Food and Drug Administration.

Article 30 Where drug insert sheets and labels are not in compliance with the Provisions, a punishment shall be imposed in accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China.


Chapter VI Supplementary Provisions

Article 31 These Provisions shall come into force as of June 1, 2006. the Provisions for Drug Packaging, Labels and Insert Sheets (Provisional) issued by State Food and Drug Administration on October 15, 2005 shall be annulled therefrom.


湖南省湘西土家族苗族自治州人民政府办公室


湘西土家族苗族自治州人民政府办公室文件
州政办发 [2005] 36号


关于印发《湘西吉凤工业园建设发展管理办法（试行）》的通知
吉首市、凤凰县人民政府，州政府各局委、各直属机构：

《湘西吉凤工业园建设发展管理办法（试行）》经州人民政府研究同意，现印发给你们，请认真遵照执行。

二OO五年十月三十一日

　　湘西吉凤工业园建设发展管理办法（试行）


为进一步加快湘西吉凤工业园（以下简称园区）建设步伐，根据《中共湘西自治州委、湘西自治州人民政府关于加快吉凤工业园建设的决定》（州发[2004]23号）精神，制定本试行办法。

　　一、明确园区特别管理模式。建立吉凤工业园是州委、州政府重大决策湘西。吉凤工业园管理委员会（以下简称管委会）是州人民政府直属机构，对园区实行统一领导、统一规划、统一管理。各部门未经州委、州政府批准，不得向园区下达各项指令性工作指标。园区内所有单位和入园项目实行“一个窗口”对外，统一由园区有关机构办理相关证照，统一收取各项费用。应交的行政事业收费在规定幅度内从低收取，需上交国家和省部分，由管委会代收上交；其它部分用于园区建设。除公安依法办案、公共卫生事件、消防救火等特殊紧急突发事件外，确需对园区企事业单位进行检查的，要提前与管委会衔接，迅速开展工作，严禁多头检查、重复检查。

二、行使州级综合经济管理权。坚持委托授权、备案监督的原则，凡应由州级有关职能部门审批的事项和核发的证书，均由有关职能部门委托管委会办理。管委会在授权范围内开展审批、工作，接受州直有关职能部门的指导和监督，并及时报州直有关部门备案。

　　三、入园项目审批。凡在园区注册的项目，属州级审批权限内的，管委会负责审批项目建议书、可行性研究报告和外商投资企业合同章程，下达有关基建和技改计划，核发批准证书，有关手续由州直有关部门委托管委会直接办理，须报省、国家审批的项目，州直各有关部门应及时转报省有关部门，并跟踪落实。

四、规划建设管理。管委会依据经批准的园区总体规划和控制性详细规划，审批园区规划范围内建设项目的选址定点，组织规划方案竞标，实施规划管理，核发《建设项目选址意见书》、《建设用地规划许可证》、《建设工程规划许可证》等证书，依法查处各类违反城市规划和建筑法律法规的行为。负责园区内建设项目的初步设计审批、报建审批、建筑市场管理、施工现场管理、质量安全监督管理，颁发《建设工程施工许可证》。建立工程质量安全监督机构，确保园区工程建设安全优质。依据《招标投标法》及实施办法监管工程项目招投标工作，监管发放《中标通知书》。园区房地产管理工作由州建设局牵头，协调吉首市、凤凰县房地产管理部门集中办理房地产相关手续。

五、环境保护管理。在委托权限内，管委会负责拟定和实施园区环境保护规划、环境功能区划、污染防治规划，建设项目环保审批或预审上报工作，审批建设项目环境影响评价报告书(表)及登记表，办理建设项目环保设施竣工验收手续，核发《排污许可证》，组织实施建设项目“三同时”管理，处理园区污染事故和污染纠纷，征收排污费，污染物总量控制和其它相关工作。

　　六、财政管理。园区实行一级财政、一级金库。组建吉凤工业园支库，园区内实现的财税收入（包括土地出让收益等）归地方所有的部分由管委会支配使用，州级以上部门拨入专项资金及其他财政性资金进入吉凤工业园支库。园区内所有非税收入归管委会用于园区建设。园区因征地向凤凰县、吉首市缴纳的耕地占用税由州财政局根据园区提供的纳税依据代扣，作为两县市对园区的投入。园区上缴的新增建设用地有偿使用费省集中部分返还到州后，园区提出项目，按程序报批，用于园区内的农田灌溉、耕作区道路等土地整理项目。园区上缴的防洪保安基金返还到州并经州水利局核实后，由州财政局拨付给园区，用于园区防洪工程建设。州财政每年安排一定资金支持园区建设。园区要在州财政局的监管下建立偿债基金专户，确保信贷资金还本付息。园区可根据财力状况和优惠政策对企业进行兑现和奖励。由吉凤工业园财政局编制年度预决算草案，经有关部门审批后执行。从2006年起，园区每年从地方财政收入（剔除优惠政策对园区项目奖励兑现部分）中给凤凰县按10%、吉首市按2%的比例分成。

七、土地管理。园区规划范围内征地拆迁安置以凤凰县、吉首市为主，州国土资源局配合。土地报批以园区国土分局为主，县市配合。办理土地报批手续时，州及州以下各项规费免交，需上交的各项规费由国土部门负责向上争取免交、减交或缓交。园区规划区内的土地由园区国土管理部门统一规划、统一管理、统一出让，任何单位和个人不得擅自在园区规划范围内征地和进行项目建设。园区内工业项目、公益事业用地可采取协议方式出让，经营性用地实行招标拍卖挂牌方式出让。园区国土分局负责园区规划范围内的国土资源管理工作，按照授权办理相关事务，开展土地执法，加强建设用地管理，按有关规定对未开工建设的闲置土地进行处置。

　　八、社会治安管理。州公安局直属分局负责维护园区内社会治安秩序，负责侦办园区内发生的刑事、行政案件，案件涉及的凤凰县、吉首市公安局要积极配合。园区范围内户籍管理、特种行业管理、危爆物品管理、综合治理工作、社会稳定工作按照属地管理原则分别暂由凤凰县、吉首市公安局负责，州公安局直属分局协助配合。

九、劳动人事管理。管委会原隶属关系不变，管理人员实行公务员制度。鼓励园区企事业单位在人事、工资制度上创新体制，实行工作绩效挂钩的工资制度。管委会劳动人事部门负责园区内企业单位用工管理和劳资纠纷的调处。管委会直属企事业单位工作人员分别实行劳动合同制和聘任制。其岗位设置、人员选配和管理由管委会负责。新补充的人员一律公开招聘。

十、其它机构建设。州国税局、州地税局、州工商局要积极创造条件，在园区逐步设立分局。在分局设立之前，州国税局、州地税局要设立征收组，派驻人员负责园区范围内的办证和税收征管；州工商局要设立工商行政管理组，派驻人员负责入园项目注册办证和工商行政管理工作；州质量技术监督局要设立质量技术监督组，派驻人员负责质量技术监督工作。派出机构实行双重管理，负责人任免应事先征得管委会同意。其它部门相关工作涉及园区的，委托园区办理，需在园区设立机构和派驻人员的，要报州政府同意。

十一、建立工作协调和督查机制。

(一）征地拆迁和环境协调机制。园区征地拆迁安置和环境协调稳定工作由凤凰县、吉首市负责。凤凰县、吉首市要抽调精干力量成立吉凤工业园征地拆迁安置环境协调稳定指挥部，负责实施征地拆迁安置和环境协调稳定工作。两县市指挥部要加强与管委会的协调配合，建立联系会议制度和协调运作机制，确保征地拆迁安置和环境协调稳定工作不影响园区建设和发展。征地拆迁安置和环境协调稳定工作经费由管委会按每亩不超过1200元的标准包干核拨，两县市指挥部按政策规定统筹安排使用。

　　(二）被征地拆迁农民利益保障机制。园区要逐步建立被征地拆迁农民利益保障机制，为园区被征地拆迁农民提供就业、养老、入学、就医、公共设施建设等一系列社会保障服务，优化园区建设环境，让被征地拆迁农民逐步分享园区建设的成果，构建园区和谐社会。

（三）建立定期联席和督查落实制度。吉凤工业园建设领导小组领导成员要明确工作职责，定期组织召开州直相关部门和凤凰县、吉首市联席会议，听取支持园区建设情况汇报，督查工作进度，解决园区建设中存在的困难和问题。州政府对凤凰县、吉首市支持吉凤工业园建设工作实行目标管理，每年下达目标任务。州政府督查室对两县市和州直各部门落实情况进行督促检查，定期通报。