Provisions for Drug Insert Sheets and Labels
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.
中共教育部党组关于向吴玲、马祖光、陈学求同志学习的决定
教育部
中共教育部党组关于向吴玲、马祖光、陈学求同志学习的决定
教党〔2004〕26号
吴玲同志生前是河南省郑州市第22中学高级教师。她自1977年参加教育工作至2004年7月因病逝世，数十年如一日，呕心沥血，勤奋工作，将毕生精力献给了党和人民的教育事业。在长期的教育工作中，她始终怀着“要为祖国和人民炼一炉好钢，一粒钢渣都不能剩下”的信念，给予每名学生平等的教育和关爱，尽心尽力把每名学生都培养成才；她对学生有着深厚的感情和炽热的爱心，将全部心血都献给了学生；她一心扑在教育教学事业上，从不追求个人名利，从不计较个人得失，直到生命最后一刻，仍念念不忘自己的学生；她刻苦钻研教学业务，不畏艰难，积极进取，勇挑重担，在平凡的岗位上创造了不平凡的业绩；她严于律己，乐于助人，模范地实践了共产党员全心全意为人民服务的根本宗旨。
马祖光同志生前是哈尔滨工业大学教授，中国科学院院士，全国五一劳动奖章获得者、黑龙江省特等劳动模范、优秀共产党员。他自1950年参加教育工作至2003年7月因病逝世，为我国的教育科研事业殚精竭虑，贡献了自己毕生的力量。他信念坚定，立志报国，为国家培养了一大批优秀人才；他德高望重，治学严谨，学识渊博，教书育人，不仅教授科学知识，而且注重教育学生树立科学精神和奉献祖国的高尚情操；他孜孜不倦，勇于探索，在科研难题面前从不退缩，取得了一系列处于国际领先水平的重大科研成果，为我国国防科技事业做出了突出贡献；他克己奉公，淡泊名利，谦逊质朴，始终践行自己“共产党员贡献要处处走在前面，利益面前不能伸手”的诺言。
陈学求同志生前是吉林农业大学研究员。他自1959年参加教育工作至2004年2月因病逝世，献身农业教育科研事业，夜以继日，辛勤工作，直至生命最后一刻。他于20世纪50年代冲破重重阻力从马来西亚回国，后来多次放弃到国外定居的机会，始终心系祖国，奉献人民；他长期奋斗在农业教学和科研第一线，勇于承担培养人才、科学研究的重任，兢兢业业，无私奉献；他坚持面向社会，深入基层，艰苦创业，不懈探索，创建了大量高粱、玉米育种材料，选育出多个高粱新品种，为农业增产增收做出了突出贡献；他热情关心农民群众的生产生活，常年工作在田间地头，指导农民学习先进农业技术，有31个春节在育种基地渡过，未能与家人团聚。陈学求同志逝世后，被追授全国五一劳动奖章。
吴玲、马祖光、陈学求同志是新时期人民教师的光辉楷模，是教育战线共产党员的杰出代表。他们的模范事迹和人格力量感人至深、催人奋进，是教育战线广大教师和教育工作者的骄傲。为进一步学习宣传吴玲、马祖光、陈学求同志的模范事迹，弘扬新时期人民教师的高尚师德和奉献精神，努力开创教育工作的新局面，教育部党组决定在全国教育系统开展向吴玲、马祖光、陈学求同志学习的活动。
教育部党组号召全国广大教师和教育工作者向吴玲、马祖光、陈学求同志学习，学习他们热爱祖国，热爱人民，忠诚于人民教育事业的崇高思想；学习他们关爱学生、教书育人、辛勤耕耘、无私奉献的高尚师德；学习他们鞠躬尽瘁、艰苦奋斗、勇于探索、开拓创新的敬业精神。希望广大教师和教育工作者以吴玲、马祖光、陈学求同志为榜样，牢记人民教师的神圣使命，学为人师，行为世范，做为人民服务的教师，做让人民满意的教师，为办好让人民满意的教育，实现中华民族的伟大复兴而努力奋斗。
