The difference between drug packaging specifications and specifications:

1. Drug packaging specifications are the "Drug Packaging and Labeling Specifications", which is a rule formulated and issued by the relevant competent authorities. As a code of conduct and work standards, the overall requirements are as follows:

(1) Drug packaging and labels must be printed in accordance with the requirements stipulated by the State Food and Drug Administration, and their words and patterns must not contain any unauthorized Approval of content. The packaging of medicines is divided into inner packaging and outer packaging. The content of drug packaging and labels shall not exceed the content limited by the drug instructions approved by the State Food and Drug Administration.

(2) The content printed on drug packaging and labels must be accurate in describing the product, except for words describing safe and rational use of drugs.

No words and logos that inappropriately promote products, such as "national new drugs", "protected varieties of traditional Chinese medicine", "GMP certification", "imported raw material repackaging", "supervised production", "Honorable product", "award-winning product", "insurance company quality insurance", "public expense reimbursement", "modern technology", "precious medicinal materials", etc.

(3) The trade name of a drug must be approved by the State Food and Drug Administration before it can be used on packaging and labels. The trade name must not be written in conjunction with the generic name and should be separated. After a trade name is registered as a trademark, it must still comply with the principles of trade name management. The ratio of the common name to the trade name should not be less than 1:2 (referring to the area); the font size of the common name should be the same without brackets.

Registered trademarks that are used as trade names without approval from the State Food and Drug Administration can be printed on the upper left or upper right corner of the packaging label, and the font size must not be larger than the generic name.

(4) For the same enterprise and the same drug of the same specifications (referring to both drug specifications and packaging specifications), the format and color of the packaging and labels must be consistent, and different trademarks are not allowed.

If the same variety of the same enterprise has different specifications, the packaging and labeling of the smallest sales unit should be clearly differentiated or the specifications should be clearly marked.

(5) The minimum sales unit of a drug refers to the smallest package of a drug directly for sale. The packaging of each minimum sales unit must be labeled and accompanied by instructions in accordance with regulations.

(6) Narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs and other specially managed drugs, external drugs and over-the-counter drugs must be printed on their large packages, medium packages, minimum sales units and labels. There are signs that comply with regulations; drugs that have special requirements for storage must be marked in a conspicuous position on the packaging and labels.

(7) In addition to complying with the provisions of these rules, the packaging and labels of imported drugs should also be marked with the "Import Drug Registration Certificate Number" or "Pharmaceutical Product Registration Certificate Number", the name of the manufacturer, etc.; The packaging and labels of packaged drugs should indicate the name of the company in the country or region of origin, production date, batch number, expiration date, and the name of the domestic sub-packaging company.

(8) The packaging and labels of drugs approved for production in other places should also indicate the name of the group, production enterprise, and production location; the packaging and labels of drugs approved for entrustment processing should also indicate the entrusting companies. Name, processing location.

(9) For all drugs sold and used in China, the text used in packaging and labels must be mainly in Chinese and use the current standard text published by the National Language and Writing Working Committee. Ethnic medicines can add their ethnic characters. Enterprises can use bar codes and foreign language comparisons on their pharmaceutical packaging according to needs; products that have obtained Chinese patents can also be marked with patent marks and patent numbers, and indicate the type of patent license.

(10) The expression method of the validity period of the packaging label, in order of year and month. Generally, the expression can be valid until a certain year and month, or it can only be expressed by numbers. For example, it is valid until October 2001, or expressed as valid until 2001.10, 2001/10, 2001-10, etc. The year must be represented by four digits, and the numbers from January to September must be preceded by 0 to represent the month by two digits.

2. Drug specifications refer to the weight (or potency) or content () or loading of the main drug contained in each tube, tablet or other unit preparation, and are important for clinical use of drugs. Based on this, the basic principles of drug specifications are as follows:

(1) The description of specifications should be as concise as possible and unnecessary words should be removed;

(2) All brackets, numbers and connecting lines etc., all use half-width input;

(3) If there are 2 or more specifications in the original text, they need to be manually split into 1 record corresponding to 1 specification;

( 4) Explanatory text should be placed after the drug content;.

(5) Specification units should be represented by symbols instead of Chinese;

(6) The numbers in the specifications should try to avoid having only 0 before the decimal point, and use unit conversion to solve such problems;

(7) When the original specifications represent each bottle and each tablet, as long as there is no ambiguity, the Need to be deleted;

(8) The rules for using brackets are: the innermost parentheses, the next middle brackets, and the next curly brackets;

(9) The specification contains a molecular formula or is valid Ingredients need to be converted into Chinese;

(10) When there are multiple expressions for the same specification in the original specification and one of the expressions can be converted through other parts of the specification, only the other parts are retained without The converted part needs to be retained. The mass volume percentage of 20 in the original specification is the converted part and can be deleted.

Extended information:

WHO’s criteria for selecting drug specifications are: usually the single dose commonly used in clinical practice is used as the basis for preparation specifications. In the case of large adjustments in dosage, (gt; 4 times the usual single dose), and then add a 5 times specification.

At present, the phenomenon of numerous and chaotic drug specifications in my country still exists, and the labeling of some traditional Chinese medicine preparation specifications is still unreasonable and unstandardized, which brings a lot of inconvenience to drug bidding, doctor prescriptions, pharmacist dispensing and other work.

1. There is no precise definition of drug specifications. Common ones include the following:

(1) Specifications include the content of small calculation units of drugs and the quantity of drugs contained in each package.

(2) Specification refers to the content of the main drug in the unit dosage form. Specifications should be compatible with commonly used dosages to facilitate clinical application.

(3) The specification of a drug refers to the amount of pharmaceutical ingredients contained in a certain pharmaceutical preparation unit.

(4) Drug specifications are usually expressed by one or a combination of content, capacity, concentration, quality (weight), quantity, etc.

(5) Specification refers to the amount of medicine contained in a unit dose of medicine. The specifications of different medicines or the same medicine can be the same or different.

2. The wording is vague and difficult to understand. .

(1) Drug specifications and packaging specifications are confused.

(2) The meaning of "base tablet weight, plain tablet weight, tablet core weight" is unclear; "approximate weight, net weight" is unclear.

3. Many chemical drug compound preparation standards do not have clear descriptions of specifications, but are only indirectly described in the prescription column, with prescriptions instead of specifications.

Baidu Encyclopedia - Drug Specifications

Baidu Encyclopedia - Drug Packaging and Labeling Specifications