(SDA Order No. 23)
State Drug Administration Order No. 23
The "Regulation for the Administration of Drug Packaging, Labels and Insert Sheets (Temporary)" which was reviewed and approved at the Administration Affairs Meeting of SDA on March 17, 2000, is hereby promulgated and shall be effective from January 1, 2001.
October 15, 2000
Article 1: This "Regulation for the Administration of Drug Packaging, Labels and Insert Sheets (Temporary)" (hereinafter the "Regulation") is promulgated in order to strengthen drug administration, standardize drug packaging, labels and insert sheets to facilitate drug transportation, storage and use and ensure the safety and efficacy of drug use by people.
Article 2: Drug packaging, labels and insert sheets shall be printed according to relevant requirements of SDA. Any text or graphics that have not been approved shall not be added to drug packaging, labels and insert sheets.
Article 3: Any unapproved introduction and promotional materials of products or enterprises in text, audio-video forms, or other materials shall not be contained within drug packaging.
Article 4: Packaging, labels and insert sheets of drugs to be sold or used within the territory of China shall use Chinese as the main language and adopt the standard simplified Chinese characters published by the State Working Committee of Language and Written Characters.
Article 5: The generic name of a drug shall be prominently printed in Chinese. If the drug also has a brand name, then the size of the letters of the generic name relative to the brand name shall not be less than 1 : 2. Space shall be left between the generic name and the brand name, the two names shall not be printed as one word.
Article 6: The brand name of a drug shall not be marked on its packaging, label or insert sheet until the brand name has been approved by SDA.
Article 7: For marks and text instructions that provide information about drugs, the character shall be clear and easily legible, and the marks shall be clear and distinguishable. They shall not come off or be unable to stick, nor may revisions or amendments be made in the form pasting or clipping.
Article 8: Drug packaging is divided between inner packaging and outside packaging.
(a) Inner packaging refers to the packaging that is in direct contact with drugs (such as ampoule, injection bottle, aluminum blister pack, etc.) Inner packaging shall ensure drug quality in the course of manufacture, transportation, storage and use, and shall be convenient for clinical use.
Should materials of inner packaging or containers (drug packaging materials) be changed, stability tests shall be conducted to study the compatibility between the new packaging materials and the drug to be packaged.
(b) Outside packaging refers to the packaging outside the inner packaging, and is divided into middle packaging and large outer packaging. Durable packaging shall be chosen for outside packaging according to the properties of the drug to be packaged, so as to ensure its quality in the course of transportation, storage and use.
Article 9: Drug labels are divided into inner packaging labels and outside packaging labels.
(a) The contents of the labels for both inner and outside packaging of a drug shall not exceed the prescribed content of the insert sheet approved by SDA. The wording of the labels shall be consistent with that of the insert sheet.
(b) Depending on size, an inner packaging label shall include as much information as possible regarding drug names, indications or functions and main treatments, means of administration, dosage, specifications, storage [requirements], manufacturing date, manufacturing batch number, validity period, approval number, name of manufacturer, etc. The drug name, specifications and manufacturing batch number must be printed on the inner label.
(c) A middle packaging label shall indicate drug name, main ingredients, properties, indications or functions and main treatments, method of administration and dosage, adverse effects, contraindications, specifications, storage [requirements], date of production, production batch number, validity period, approval number, name of manufacturer, etc.
(d) A larger outer packaging label shall indicate drug name, specifications, storage [requirements], date of production, production batch number, validity period, approval number, name of manufacturer as well as necessary contents not specified on relevant insert sheet, including packaging quantity, transportation precautions and other marks.
(e) The validity period shall be expressed as: expires in X month X year.
(f) If all information regarding adverse effects, contraindications and warnings due to limited space is not able to be included on a middle packaging label, "refer to insert sheet for details" shall be noted for each relevant item on the label.
Article 10: Requirements for the packaging of active ingredients shall refer to the Item (a) of Article 8, and the requirements for labels of active ingredient shall refer to that for labels of large outer packaging of preparations.
Article 11: Packaging of the smallest unit of a drug shall have a label printed on or attached to it, and include an insert sheet.
Article 12: An insert sheet of a drug shall contain basic scientific information regarding the drug's safety, efficacy, etc.
An insert sheet of a drug shall include: drug name (generic name, English name, Chinese pinyin, chemical name), molecular formula, molecular weight, structure (ingredients shall be noted for compound preparations and biological products), properties, pharmacological principles, toxicological precautions, indications, means of administration and dosage, adverse effects, contraindications, warnings (for drugs use by women during pregnancy or lactation periods and by children, for interactions between different drugs and other types of interactions such as with tobacco, alcohol etc.), overdose (including symptoms, first aid measures, antidotes), validity period, storage, approval number, name of manufacturers (including address and contact phone) and other contents. If relevant information for a certain item is not confirmed, then the item shall be indicated as "not confirmed"; if it has been clearly confirmed that no effect would be produced, it shall be indicated as "none [effect]".
Drug manufacturers shall proactively track the use affects of a drug after it is brought to market, and shall apply for amendment of its insert sheet when necessary. An uniform format (see Attachment I and II for the uniform format of drug insert sheet) shall be adopted to print drug insert sheet, which content shall be consistent with the approved insert sheet by SDA.
Article 13: In addition to unit content, the dosage of a drug shall also be described in common and easy-to-understand expressions such as "x pills each time, x times a day", "x bottles per time, x times a day" etc., so as to correctly guide drug use.
Article 14: Proper symbols that conform with relevant regulations shall be printed on the middle packaging, larger outer packaging, labels and insert sheets of drugs that are specially administered such as narcotics, psychiatric drugs, toxic drugs for medical purposes, radioactive drugs, etc., drugs for external use, and OTC drugs. For a drug that must be stored under special conditions, relevant requirements shall be noted on a prominent position on the packaging and labels, and be indicated in the insert sheet.
Article 15: During the process of drug registration application, the packaging, labels and insert sheet of a drug shall be revised and approved according to the relevant regulations of different categories of drugs. Any changes and amendments to the packaging, label or insert sheet of a drug that has been registered and begun marketing shall be revised and approved according to the same revision and approval procedures for the original packaging, label and insert sheet.
Article 16: Relevant drug administration departments or agencies shall order a drug manufacturer to correct the packaging, label or insert sheet which does not conform with this Regulation, and withdraw drugs that are already being marketed. The manufacturer is subject to the penalty provisions of the "Drug Administration Law" and "Implementation Method of the Drug Administration Law".
Article 17: SDA shall be responsible for the interpretation of this "Regulation".
Article 18: This "Regulation" shall be effective from January 1, 2001.
For "Format of the Insert Sheets of Chemical Drugs and Biological Products ", Please Click here.
For "Format of the Insert Sheet of TCM", Please Click here.