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.


财政部 中国民用航空总局


财政部 中国民航总局关于印发《民航机场管理建设费使用管理暂行办法》的通知
1997年12月18日，财政部 中国民航总局


各省、自治区、直辖市、计划单列市财政厅（局），财政部驻各省、自治区、直辖市、计划单列市财政监察专员办事处，民航各地区管理局、各省（区、市）局、各机场：
为加强民航机场管理建设费使用管理工作，根据财政部《关于印发民航机场管理建设费管理办法的通知》（财工字〔1996〕373号）规定，特制定《民航机场管理建设费使用管理暂行办法》。现印发给你们，请遵照执行。执行中如有问题，请及时与我们联系。

附件：民航机场管理建设费使用管理暂行办法
第一条 为加强民航机场管理建设费（以下简称“机场建设费”）的使用管理工作，保证专款专用，提高资金使用效益，根据财政部《关于印发民航机场管理建设费管理办法的通知》（财工字〔1996〕373号）精神，特制定本办法。
第二条 机场建设费的使用范围。
机场建设费专项用于机场建设，主要包括机场飞行区、航站区、机场围界、安全和消防设施及设备、空中交通管制系统的建设以及用于归还上述建设项目的贷款本息支出和财政部批准的其他支出。财政部批准的其他支出主要包括票证印刷费和分配给各机场的代征手续费等支出。
第三条 机场建设费的分类。
（一）机场建设费按管理单位分为民航总局集中部分和机场留成部分。
民航总局集中部分指各机场上缴中央国库，由民航总局集中管理的50％部分。
机场留成部分包括两个部分：
1．民航总局管理机场（含以民航总局管理为主的机场和民航总局与军队合用的机场）上缴中央国库，由民航总局返还各机场的50％部分。
2．地方管理机场（含以地方管理为主的机场和地方与军队合用的机场）上缴地方国库，由地方财政下拨机场的50％部分。
（二）机场建设费按用途分为基本建设支出、技术改造支出、建设还贷支出和其他支出。
第四条 机场建设费的使用原则。
机场建设费坚持先收后支、量入为出、统筹规划、分块管理、专款专用的原则，年末结余可结转下年使用。
第五条 机场建设费的预决算管理制度。
每年11月15日前各机场向民航总局报送下年度本单位机场建设费收支预算，其中机场留成部分的支出预算要和当地政府协商一致，并抄送财政部驻各省、自治区、直辖市财政监察专员办事处（以下简称“财政专员办”）备案。每年12月10日前，民航总局在审核汇总各机场预算的基础上，一式两份上报财政部审批。
基本建设项目支出预算和技术改造项目支出预算可先报总规模由财政部审批，待有关部门批准基本建设和技术改造计划后，民航总局应将分项目预算报财政部审核。建设还贷支出预算和其他支出预算必须按项目编制详细预算。具体编制办法按财政部《关于印发民航机场管理建设费年度预算编制办法（试行）的通知》（财工字〔1997〕87号）执行。
经财政部正式批复的年度预算不得随意调整，在执行过程中，确因特殊情况需要调整预算时，民航总局应及时报财政部审批。
每年年度终了1个月内，各民航机场负责编制上年度机场建设费收支决算报民航总局，民航总局在审核汇总的基础上于3月31日前一式两份报财政部审批。
凡不及时上报机场建设费决算的单位，不予考虑机场建设费项目。
第六条 民航财务部门必须参加机场建设费项目的立项－－可行性研究－－初步设计－－概算审批等前期工作。项目资金的配置由各级财务部门依据国家资本金制度和现有资金规模会同计划、基建等部门确定。
第七条 机场建设费项目资金审批的规定：
机场建设费中用于国家基本建设和技术改造项目的投资，应严格按照国家有关的规定和程序办理。
建设还贷支出、其他支出由民航总局编制支出预算报财政部审批后实施。其他支出由民航总局在机场建设费集中资金中列支，其中：票证印刷费实行据实列支的办法；代征手续费按机场建设费实际入库数的千分之二计提。分配给各机场的代征手续费方案由民航总局制定并报财政部备案。各机场收到代征手续费后应作为机场营业外收入处理。
第八条 机场建设费申请拨款的规定。
上缴中央国库的机场建设费由民航总局统一向财政部请款，财政部根据资金入库情况和年度预算向民航总局拨款。
上缴地方国库的机场建设费由机场向当地财政部门请款，财政部门根据资金入库进度和年度预算拨款。
各机场财务部门依据财政部审批的年度预算向民航总局财务司办理拨款手续或使用机场留成部分机场建设费。
各机场财务部门根据项目进度向建设或使用单位下拨资金。
第九条 机场建设费资金管理规定。
民航总局财务司收到财政部下拨的机场建设费后，属于机场留成部分要及时下拨各机场；由民航总局集中使用的部分应存入支出专户中，按照财政部批复的预算分项核算并管理。
各机场财务部门收到民航总局下拨的留成部分机场建设费和集中部分机场建设费后，都要根据有关批复、概算、合同，实行专款专用、专户存储、分项核算，建立健全内部管理制度。
对于机场建设费建设项目，各机场财务部门要严格按经济合同，根据工程实际进度支付工程款，按照项目概算严格控制投资规模和投资标准。
第十条 机场建设费项目超支原则上不予追加。但由于不可抗力因素造成的，超支额在项目概算10％（含10％）以内的，报民航总局审批追加；超过10％的，由民航总局报原立项、可研、资金审批机关审批。追加超支的机场建设费按总概算中机场建设费所占比例分担。
第十一条 机场建设费的监督管理。
财政部、民航总局负责对机场建设费使用情况进行管理，机场建设费使用的日常财政监督检查工作由各专员办事处负责。任何单位不得截留、挪用和擅自扩大使用范围，违者按违反财经纪律论处。
为了保证机场建设费建设项目专款专用，使用机场建设费在1000万元（含1000万元）以上的基建项目，其竣工决算必须通过会计师事务所审计，使用机场建设费3000万元（含3000万元）以上项目的审计结果由使用单位报财政部和民航总局备案。
第十二条 本办法自1997年1月1日起执行并由财政部商民航总局负责解释。