What are the regulations of the pharmaceutical industry on the printing content of color copperplate label paper?

The pharmaceutical industry has strict regulations on the printing content of color copperplate label paper, which are designed to ensure the accuracy of drug information and the safety of patients. The following are the main summaries of these provisions:

First,General requirements

1.Content compliance: The text and pattern on the drug label must comply with the provisions of the National Drug Administration (NMPA) or other relevant regulatory agencies, and shall not add any content without approval.

2.Information accuracy: The content printed on the label should be accurate in the expression of the product, in addition to the expression of safe and rational drug use, shall not be printed with a variety of inappropriate promotional product text and logos, such as "national new drugs", "Chinese medicine protected varieties" and other exaggerated promotional terms.

Second,Information that must be included

1.Basic Drug information:

Generic name of the drug: must be clearly marked, and the font size must meet the requirements.

Indications or functional indications: A brief description of the drug's use or therapeutic scope.

Specification: Information about the dosage or content of a drug.

Usage and dosage: Guide patients to use the correct dosage and method of drugs.

Production Date and batch number: Used to trace the production lot and date of the drug.

Validity period: Clearly label the validity period of the drug, usually in the format of "validity until XXXX XX months".

Manufacturer: name of the enterprise that produces the drug.

2.Other important information (may vary depending on package size and type) :

For the inner packaging label of the drug in direct contact, if the package size is too small to indicate all the above contents, at least the key information such as the generic name of the drug, specifications, product batch number, and expiration date should be marked.

The outer packaging label may need to contain more detailed information, such as [ingredients], [storage], [adverse reactions], [contraindications], [precautions], etc. If not all can be indicated, the main content should be marked and the words "See instructions".

Third,Additional requirements for special drugs

For drugs under special management, such as narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, etc., special marks must be printed on the labels that comply with the provisions, and additional information such as storage conditions must be indicated.

Fourth,Special provisions on imported drugs

In addition to complying with the above general provisions, the packaging and labels of imported drugs should also be marked with information such as "import drug registration Certificate Number" or "Pharmaceutical product registration Certificate Number" and the name of the manufacturer. The packaging and labels of imported sub-packaged drugs shall indicate the name of the enterprise in the original country or region, the date of production, the batch number, the validity period and the name of the domestic sub-packaging enterprise.

Fifth,Other precautions

Writing standards: For drugs sold and used within the territory of China, the language used in the packaging and labels must be mainly in Chinese, and use the current standard language published by the State Language Commission. Ethnic medicine can add its ethnic characters.

Environmental protection and non-toxic: The drug label should use materials that meet the standards of the medical industry, non-toxic and non-permeable to ensure the safety of the drug packaging process.

To sum up, the pharmaceutical industry has detailed and strict regulations on the printing content of color copperplate label paper, which ensure the accuracy of drug information and the safety of patients. In actual operation, drug manufacturers should strictly abide by the relevant regulations to ensure the compliance and effectiveness of drug labels.