Regulations on the Administration of Drug Inserts and Labels (Bureau Order No. 24)

State Food and Drug Administration Order

No. 24

The "Regulations on the Administration of Drug Instructions and Labels" were reviewed and adopted by the State Food and Drug Administration's executive meeting on March 10, 2006, and are hereby promulgated and shall come into effect on June 1, 2006.

Director: Shao Mingli

March 15, 2006

Regulations on the Administration of Drug Instructions and Labels

Chapter 1 General Provisions

Article 1 is to standardize the management of drug instructions and labels. This document is formulated in accordance with the "Drug Administration Law of the People's Republic of China" and the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" Regulation.

Article 2 The instructions and labels for drugs marketed and sold within the territory of the People’s Republic of China and the People’s Republic of China shall comply with the requirements of these regulations.

Article 3 Drug instructions and labels shall be approved by the State Food and Drug Administration.

The label of a drug shall be based on the instructions, and its content shall not exceed the scope of the instructions, and shall not be printed with words or logos that imply efficacy, misleading use, or inappropriately promote the product.

Article 4 Pharmaceutical packaging must be printed or affixed with labels in accordance with regulations, and any other text, audio, video and other materials that introduce or promote products or companies must not be included.

The smallest package produced by a pharmaceutical manufacturer for marketing must be accompanied by instructions.

Article 5 The textual expressions in drug instructions and labels should be scientific, standardized and accurate. Over-the-counter drug instructions should also be expressed in easy-to-understand words to facilitate patients' own judgment, selection and use.

Article 6 The text in drug instructions and labels should be clear and legible, and the labels should be clear and eye-catching. There should be no signs of falling off or weak pasting, and no modification by pasting, cutting, or alteration. Or add.

Article 7 Drug instructions and labels should use the standardized Chinese characters promulgated by the National Language Working Committee. If other characters are added for comparison, the Chinese character expressions shall prevail.

Article 8 For the purpose of protecting public health and guiding the correct and rational use of drugs, drug manufacturers may proactively propose to add warnings on drug instructions or labels, and the State Food and Drug Administration may also require drug Manufacturers add warnings on instructions or labels.

Chapter 2 Drug Instructions

Article 9 Drug instructions should contain important scientific data, conclusions and information on the safety and effectiveness of drugs to guide the safe and rational use of drugs. The specific format, content and writing requirements for drug instructions are formulated and issued by the State Food and Drug Administration.

Article 10: Drug instructions should use special vocabulary promulgated or standardized by the state to express disease names, pharmaceutical terms, drug names, clinical test names and results, and weights and measures units should comply with national standards. .

Article 11 The drug instructions shall list all active ingredients or all the flavors of traditional Chinese medicine in the formula. Injections and over-the-counter drugs should also list the names of all excipients used.

If the drug prescription contains ingredients or excipients that may cause serious adverse reactions, this should be explained.

Article 12 Drug manufacturers should proactively track the safety and effectiveness of drugs after they are put on the market. If it is necessary to modify the drug instructions, they should submit an application in a timely manner.

Based on information such as adverse drug reaction monitoring and drug re-evaluation results, the State Food and Drug Administration may also require drug manufacturers to modify drug instructions.

Article 13 After the drug instructions are approved to be modified, the drug manufacturer shall immediately notify the relevant drug operating enterprises, user units and other departments of the modified contents, and use the modified instructions and labels in a timely manner as required.

Article 14: Drug instructions should fully contain information on adverse drug reactions and specify adverse drug reactions in detail.

If a drug manufacturer fails to promptly modify the instructions based on the safety and effectiveness of the drug after it is put on the market or fails to fully explain the adverse reactions of the drug in the instructions, the manufacturer shall be responsible for the adverse consequences caused thereby.

Article 15 The date of approval and modification of the drug package insert shall be clearly marked in the package insert.

Chapter 3 Labels of Drugs

Article 16 The labels of drugs refer to the contents printed or affixed on the drug packaging, which are divided into inner labels and outer labels. The inner label of a drug refers to the label of the package that is in direct contact with the drug, and the outer label refers to the label of other packages other than the inner label.

Article 17 The internal label of a drug shall include the common name of the drug, indications or main functions, specifications, usage and dosage, production date, product batch number, validity period, production enterprise, etc.

If the package size is too small to indicate all the above contents, at least the generic name, specifications, product batch number, expiration date, etc. of the drug should be marked.

Article 18 The outer label of a drug shall indicate the common name, ingredients, properties, indications or main functions, specifications, usage and dosage, adverse reactions, contraindications, precautions, storage, production date, product Batch number, validity period, approval number, production company, etc. If the indications or functions, usage and dosage, adverse reactions, contraindications, and precautions cannot be fully stated, the main content should be marked and the words "see instructions for details" should be noted.

Article 19 The label of the packaging used for transportation and storage should at least indicate the generic name of the drug, specifications, storage, production date, product batch number, validity period, approval number, production enterprise, or Indicate necessary contents such as packaging quantity, transportation precautions or other markings as needed.

Article 20 The label of the raw material drug shall indicate the name of the drug, storage, production date, product batch number, validity period, implementation standard, approval number, production enterprise, as well as the packaging quantity and transportation. Precautions and other necessary contents.

Article 21 If the same drug produced by the same drug manufacturer has the same drug specifications and packaging specifications, the content, format and color of the label must be consistent; if the drug specifications or packaging specifications are different, the label must be consistent. Labels should be clearly distinguished or specification items should be clearly marked.

If the same drug produced by the same drug manufacturer is managed as a prescription drug and an over-the-counter drug, the packaging colors of the two should be clearly different.

Article 22 Drugs that have special requirements for storage should be clearly stated on the label.

Article 23 The validity period on the drug label shall be marked in the order of year, month and day, with the year represented by four digits and the month and day represented by two digits. The specific marking format is "valid until XXXX year XX month" or "valid until XXXX year XX month XX day"; it can also be represented by numbers and other symbols as "valid until XXXX.XX." or "valid until XXXX/XX/ XX" etc.

The validity period of preventive biological products shall be marked in accordance with the registration standards approved by the State Food and Drug Administration. The validity period of therapeutic biological products shall be calculated from the packaging date, and the validity period of other drugs shall be marked from the production date.

If the validity period is marked as a day, it should be the day before the corresponding year, month and day of the starting date. If it is marked as a month, it should be the month before the corresponding year and month of the starting month.

Chapter 4 Use of Drug Names and Registered Trademarks

Article 24 The drug names marked in drug instructions and labels must comply with the general drug regulations published by the State Food and Drug Administration The naming principle of the name and trade name shall be consistent with the corresponding content of the drug approval document.

Article 25 The generic name of a drug should be prominent and prominent, and its font, size and color must be consistent and meet the following requirements:

(1) For horizontal labels, they must be It must be marked in a prominent position within the upper third of the range; for vertical labels, it must be marked in a prominent position within the right third of the range;

(2) Cursive scripts, seal scripts, etc. that are difficult to identify are not allowed The fonts must not be modified with italics, hollows, shadows, etc.;

(3) The font color should be black or white, forming a strong contrast with the corresponding light or dark background;

(3) The font color should be black or white, forming a strong contrast with the corresponding light or dark background;

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(4) Unless it is impossible to write in parallel due to packaging size restrictions, writing in separate lines is not allowed.

Article 26 The trade name of a drug shall not be written side by side with the generic name, its font and color shall not be more prominent and conspicuous than the generic name, and its font shall not be larger than half the font used for the generic name in terms of single character area. one.

Article 27 It is prohibited to use unregistered trademarks and other drug names that have not been approved by the State Food and Drug Administration in drug instructions and labels.

If a registered trademark is used on a drug label, it should be printed on the corners of the drug label. If it contains text, the font size shall not be larger than one quarter of the font used for the common name in terms of single character area.

Chapter 5 Other Provisions

Article 28 Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs that have special labels stipulated by the state , its instructions and labels must be printed with the prescribed logo.

If the state has special regulations on drug instructions and labels, those regulations shall prevail.

Article 29 The label management regulations for Chinese herbal medicines and Chinese herbal medicine pieces shall be separately formulated by the State Food and Drug Administration.

Article 30: Drug instructions and labels that do not comply with these regulations will be punished in accordance with the relevant provisions of the "Drug Administration Law of the People's Republic of China".

Chapter 6 Supplementary Provisions

Article 31 These regulations will come into effect on June 1, 2006. The "Regulations on the Administration of Drug Packaging, Labeling and Instructions (Interim)" issued by the State Food and Drug Administration on October 15, 2000 were abolished at the same time.