Order of the State Food and Drug Administration

No. 24

The "Regulations on the Administration of Drug Instructions and Labels" were reviewed and approved by the State Food and Drug Administration on March 10, 2006, and are now promulgated. They will come into effect on June 1, 2006.

Director: Shao Mingli

March 15th, 2006

Regulations on the Management of Drug Instructions and Labels

Chapter 1 General Provisions

Article 1: In order to standardize the management of drug instructions and labels, this regulation is formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementation Regulations of the Drug Administration Law of the People's Republic of China.

Article 2: The instructions and labels of drugs listed and sold within the territory of the People's Republic of China shall comply with the requirements of these regulations.

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

The labeling of drugs should be based on the instructions, and its content should not exceed the scope of the instructions. It should not contain words or labels that suggest therapeutic effects, mislead users, or improperly promote the product.

Article 4: Drug packaging must be printed or labeled in accordance with regulations, and shall not contain any other text, audio, video, or other materials introducing or promoting products or enterprises.

The minimum packaging produced by pharmaceutical production enterprises for sale on the market must be accompanied by an instruction manual.

Article 5: The textual expression of drug instructions and labels shall be scientific, standardized, and accurate. The instructions for over-the-counter drugs should also be written in easily understandable language for patients to make their own judgments, choices, and uses.

Article 6: The text in the drug instructions and labels shall be clear and distinguishable, and the markings shall be clear and eye-catching. There shall be no signs of printing detachment or weak adhesion, and no modifications or supplements shall be made by pasting, cutting, or erasing.

Article 7: The drug instructions and labels shall use standardized Chinese characters published by the National Language and Language Working Committee. If other language comparisons are added, the Chinese character expression shall prevail.

Article 8: For the purpose of protecting public health and guiding the correct and reasonable use of drugs, drug production enterprises may voluntarily propose to add warning words on the drug instructions or labels, and the State Food and Drug Administration may also require drug production enterprises to add warning words on the instructions or labels.

Chapter 2 Drug Instructions

Article 9: Drug instructions shall 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 shall be formulated and published by the State Food and Drug Administration.

Article 10: The description of disease names, pharmaceutical professional terms, drug names, clinical test names, and results in drug instructions shall use specialized vocabulary uniformly issued or standardized by the state, and the units of measurement and measurement shall comply with the provisions of national standards.

Article 11: The drug instruction manual shall list all active ingredients or all traditional Chinese medicine flavors 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, they should be explained.

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

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

Article 13: After the modification of the drug instructions is approved, the drug production enterprise shall immediately notify the relevant drug trading enterprises, user units, and other departments of the modified content, and use the modified instructions and labels in a timely manner as required.

Article 14: The drug instruction manual shall fully contain information on adverse drug reactions and specify them in detail. If a drug production enterprise fails to modify the instructions in a timely manner based on the safety and effectiveness of the drug after its listing, or fails to fully explain the adverse reactions of the drug in the instructions, the resulting adverse consequences shall be borne by the production enterprise.

Article 15: The approval date and modification date of drug instructions shall be prominently marked in the instructions.

Chapter 3 Labeling of Drugs

Article 16: The label of a drug refers to the content printed or affixed on the drug packaging, which is divided into inner label and outer label. The inner label of a drug refers to the label on the packaging that comes into direct contact with the drug, while the outer label refers to the label on other packaging than the inner label.

Article 17: The internal label of a drug shall include the general name of the drug, indications or functional indications, specifications, usage and dosage, production date, product batch number, expiration date, production enterprise, etc.

If the packaging size is too small to indicate all the above contents, at least the general name, specifications, product batch number, expiration date, and other contents of the drug should be marked.

Article 18: The outer label of a drug shall indicate the general name, ingredients, characteristics, indications or functional indications, specifications, usage and dosage, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiration date, approval number, production enterprise, and other contents of the drug. If the indications or functional indications, usage and dosage, adverse reactions, contraindications, and precautions cannot all be indicated, the main content should be marked and the words "see instructions for details" should be indicated.

Article 19: The labels of packaging used for transportation and storage shall at least indicate the general name, specifications, storage, production date, product batch number, expiration date, approval number, production enterprise of the drug, and may also indicate necessary contents such as packaging quantity, transportation precautions, or other markings as needed.

Article 20: The label of raw materials shall indicate the drug name, storage, production date, product batch number, expiration date, executive standard, approval number, production enterprise, and also indicate necessary contents such as packaging quantity and transportation precautions.

Article 21: If the same drug produced by the same drug manufacturing enterprise 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, their labels should be clearly distinguished or the specification items should be clearly marked.

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

Article 22: Drugs with special storage requirements shall be clearly marked in a prominent position on the label.

Article 23: The validity period in drug labels shall be indicated 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 labeling 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".

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

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

Chapter 4 Use of Drug Names and Registered Trademarks

Article 24: The drug name indicated in the drug instructions and labels must comply with the naming principles of the general drug name and commodity name published by the National Food and Drug Administration, and be consistent with the corresponding content of the drug approval certificate.

Article 25: The generic name of a drug shall 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 prominently marked within the upper one-third range; For vertical labels, they must be prominently marked within the right one-third range;

（2） Do not use fonts that are difficult to recognize such as cursive script and seal script, and do not use italics, hollows, shadows, or other forms to modify the font;

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

（4） Except for those that cannot be written in parallel due to packaging size limitations, they cannot be written separately.

Article 26: The name of a drug product shall not be written in conjunction with the general name, and its font and color shall not be more prominent and prominent than the general name. The font, measured by the area of a single word, shall not exceed half of the font used in the general name.

Article 27: The use of unregistered trademarks and other drug names not approved by the State Food and Drug Administration is prohibited in drug instructions and labels.

If a registered trademark is used on a drug label, it should be printed on the edges and corners of the drug label. If it contains text, the font size, measured by the area of a single word, should not exceed one fourth of the font used for the generic name.

Chapter 5 Other Provisions

Article 28: If anesthetic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, topical drugs, and over-the-counter drugs have special labels as stipulated by the state, their instructions and labels must bear the prescribed labels.

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

Article 29: The labeling management regulations for Chinese medicinal materials and Chinese herbal decoction pieces shall be separately formulated by the State Food and Drug Administration.

Article 30: If the drug instructions and labels do not comply with these regulations, punishment shall be imposed 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 shall come into effect as of June 1, 2006. The "Regulations on the Administration of Drug Packaging, Labeling, and Instructions (Provisional)" issued by the National Drug Administration on October 15, 2000 shall be abolished simultaneously.