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.
司法权威与司法诚信
在中国几千年的历史长河中，诚信向来被尊崇为做人的立身之本，“言必行，行必果”作为名言传承千年，而在发达资本主义国家，诚信更是被视为个人和企业的第二生命，一旦有不诚信的记录，不诚信者在社会中将寸步难行。由此可见，即使是在不同的文化背景下，诚信本身的重要性都不言而喻。当前，在我国大力倡导构筑整个社会诚信体系的前提下，强调司法诚信的重要性，对司法诚信进行更深层次的探讨更凸现其重要意义。
如果说通常意义的诚信一词体现对个体的要求，那么司法诚信则代表了国家司法机关在广大公民心目中的公信力。有人或许会质疑司法诚信这一说法，认为司法权威本身就包含了诚信的意义，其实事实并非如此。由于掌控了国家的司法权力，司法行为具有强制话语权，但这只是司法的单方表象，并不表明公民同时就对司法机关本身的诚信认同，也不表明法律与诚信是与生俱来的孪生兄弟，司法机关同样需要用司法行为来构筑公民心中的诚信长城。如果从法律的角度来说，法律是所有社会规则的最低底线，也是社会正义的最后一道防线，所以，法律的重要性不言而喻，而法律的真正实现最终主要依靠司法机关的司法行为。司法诚信概念在公民心中的产生并最终形成确信、司法机关取信于民的根本落脚点在于公正司法。我们唯有通过公正司法，用行动来说话，使每一个公民在日常生活的一点一滴中亲身感受到司法的诚信，从心中确立司法诚信的理念，知法、尚法、用法，从而在整个社会营造一种法律至上、法律神圣的氛围，使各种社会行为最终落脚于“有法可依、有法必依、执法必严、违法必究”这十六个字上，才能真正建立起我们所寄予厚望的社会主义法治国家。
中国封建社会司法理念追求“无讼是求”，倡导建立以道德为主导的社会评价体系，司法诚信也由于封建社会本质的局限性而变得遥不可及。社会主义真正使人民当家作主，法律由国家权力机关全国人大及其常委会制定，司法机关对人大负责，这就从根本上奠定了我国当前司法诚信的基石。依法治国和建设社会主义民主政治方略的提出，更是为我国的司法诚信提供了有力保障。如今在全国法院系统大力开展的“规范执法行为，促进执法公正”专项整改活动以及进行得如火如荼的反司法腐败行动，其目的正是要在加大司法程序的透明度、采取多种便民利民措施的坚持上，增强司法诚信度，做到司法为民、司法利民、司法护民和司法惠民，最终取信于民。基于以上原因，司法诚信这一概念的提出是当前时代发展和司法机关内部改革的急需。
谈到司法诚信，司法机关应当是这一理念的直接实现者而不应当在构建社会诚信体系的趋势面前喑哑无语。司法机关至少应当从以下几个方面积极努力：一是树立正确的法律至上、司法为民理念，并将该理念真正体现在司法实践中；二是加强学习，增加知识储备，优化知识结构，使司法人员有足够的司法智慧和司法技能守护好社会公平和正义这道防线；三是完善管理机制，如严格把好案件质量关，健全岗位目标考核和违法违纪监督追究制度；四是努力向法官职业化方面迈进，积极协调，克服司法地方化、行政化和法官非职业化的弊病。真正打造出一支崇尚法律、清正廉洁、精通业务和高效务实的司法队伍，有这样的队伍，构建起来的司法诚信大厦才不是空中楼阁。
司法诚信的确立，对我国司法实践具有积极的现实意义和深远的历史意义：有利于法律权威性的确立；有利于法律的正确实施和公民民主法制意识的提高；在全球经济一体化形势之下，争取与国际司法接轨，使司法为社会经济的发展提供有力的司法保障，使我国在纷繁复杂的国际竞争中笑看潮头、立于不败。基于司法诚信的这几个积极意义，作为社会所关注的“执行难”以及由此衍生的所谓“法律白条”等热点、难点问题也就可以随之解决。当前各地司法机关针对“执行难”问题所提出的种种技术性操作在很大程度上只是触及问题的皮毛而非实质，解决问题的关键还是应当回到构建司法诚信这一具有全局性高度的问题上来。因为司法诚信源于司法公正，全体公民对司法本身已经形成信念，法律与正义和公平同在，在司法诚信的基础上，让诉讼当事人赢得清清楚楚，输得明明白白。这样的情况下再不执行生效法律文书，就不再是一个单纯的法律执行问题，它违反了整个社会的基本准则和信用要求，必然全社会所不容。
我们日常生活中常提到司法权威一词，其实，司法权威和司法诚信两者休戚相关，无信则无威，有信则威存。没有诚信的司法是悲哀的，更是危险的，权威和诚信同为司法的内核，任何一边不可偏废。司法诚信是当代社会中最大、最重要的诚信，我们的每一个社会行业若是都能站在司法诚信的高度和运用司法诚信的思维，一切棘手的问题都能迎刃而解。
社会需要司法诚信！社会呼吁司法诚信！
作者：唐时华 单位：云南省晋宁县人民法院
邮编：650600 电话：0871－7892330
原载于《昆明宣传》杂志
