Pharmaceuticals Can an approval number be more than one drug?

Executive standard: Q 12BJ5419-2005 is the Beijing medical device standard, Q stands for the device, BJ stands for the Beijing local standard, 5419 is the approval number, and 2005 is the year of approval.

Approval number: 2005 Tianjin Health Care Word X002 is the health care number approved by Tianjin Health and Epidemic Prevention. On the whole, the above two opinions are correct, this product is a medical device, not a drug, and the implementation of Beijing quality standards.

According to the existing relevant regulations, the product can be advertised as a health care effect, but it is not allowed to advertise the best effect on a certain disease.

You are buying health care products, which have no ** effect! If he advertises any ** effect, it is a violation! You can report it! In addition, the same drug name, different manufacturers, and different national drug quasi-brand names are also different!

No, it's not.

The approval number is equivalent to a person's ID card, even if the name is the same, the ID number is not the same if it is not a person, so a drug has an approval number, and there are many approval numbers corresponding to drugs with the same name produced by different manufacturers, and even the same manufacturer has different specifications for the same drug, and the approval number is not the same.

There are two formats of drug approval numbers, and the difference is that the year of issuance is different.

1. The national drug quasi-word H (z, s, j) + 4-digit year number + 4-digit sequence number is the drug approval number issued by the State Drug Administration before December 31, 2001.

2. The quasi-word of Sinopharm + 1-digit letter (drug category) + 8-digit number is the new drug, generic drug and drug that has been approved for production since January 1, 2002 and the drug that has been rectified or re-evaluated by local standards and upgraded to national standards, and the new drug approval number format is adopted.

The letter "H" is used for chemical drugs, the letter "Z" is used for traditional Chinese medicine, the letter "B" is used for health care drugs rectified by the State Drug Administration, the letter "S" is used for biological products, the letter "T" is used for in vitro chemical diagnostic reagents, the letter "F" is used for pharmaceutical excipients, and the letter "J" is used for imported packaged drugs.

The first digit of the number is the **** of the original approval number, in which "10" represents the drug approved by the former Ministry of Health, "19" and "20" represent the drugs approved by the State Drug Administration before January 1, 2002, and the first two digits of the other provincial administrative divisions ** (see Annex I) are the drugs approved by the original provincial health administrative departments.

The first digit is the last two digits of the year of renewal of the approval number, but the last two digits of the original year number are still used in the approval number of the Ministry of Health and the State Drug Administration. The 5th to 8th digits of the number are sequential numbers.

Legal analysis: The drug approval number is a sign of the legality of drug production. According to the regulations, "each specification of each drug is issued with an approval number.

Except for the entrusted production and off-site processing of drugs approved by the State Drug Administration, different manufacturers of the same drug are issued with different drug approval numbers". The drug approval number shall be marked on the outer label of the drug packaging and the label of the package used for transportation and storage. Except for a very few drugs, there is only one drug approval number on the label of the drug packaging.

Legal basis: "Drug Administration Law of the People's Republic of China" Article 31 The production of new drugs or drugs with national standards must be approved by the drug regulatory department and issued with a drug approval number.

The drug batch number refers to the batch number of the drug production. is a set of numbers or letters plus numbers used to identify a "batch".

The drug approval number is the legal approval certificate of a drug by the drug regulatory department for a specific manufacturer according to the statutory standards, production process and production conditions, and each variety of each manufacturer has a specific approval number.

The use of lot numbers is always associated with batches. Article 76 of China's GMP stipulates the meaning of "batch": a certain number of drugs with the same nature and quality within the specified limit, and produced in the same production cycle.

It can be seen that the most fundamental problem to be reflected in the "batch" is the uniformity of quality within the allowable limit.

Drug approval number and lot number are two different concepts.

The drug approval number is the unique identification issued by the State Drug Administration, and the number of a drug has been approved for marketing. It consists of 14 digits, of which the first 6 digits represent the approval number holder's **, and the last 8 digits represent the registration certificate number of the drug.

The drug batch number is the number of each batch of drugs carried out by the drug manufacturer in the process of drug production in order to facilitate traceability management. The batch number is generally composed of a string of numbers or a combination of numbers and letters, usually including information such as the date of manufacture, the place of manufacture, and the manufacturer.

Therefore, the drug approval number is the only number for the drug to be approved for marketing, and the drug batch number is the number of each batch of drugs in the drug production process for ease of management.

Legal analysis: The drug approval number is the legal approval certificate of a drug by the drug regulatory department for a specific manufacturer according to the statutory standards, production process and production conditions, and each variety of each manufacturer has a specific approval number. Pharmaceutical manufacturers must obtain the drug approval number before production.

Except for Chinese herbal medicines and Chinese herbal decoction pieces that have not been subject to approval management. The catalogue of varieties of Chinese herbal medicines and Chinese herbal decoction pieces that are subject to approval and management shall be formulated by the drug regulatory department in conjunction with the competent department of traditional Chinese medicine.

Legal basis: Drug Administration Law of the People's Republic of China

Article 24 Drugs marketed in China shall be approved by the drug regulatory department and obtain a drug registration certificate; However, Chinese herbal medicines and Chinese herbal decoction pieces that have not been subject to approval management are excluded. The catalogue of varieties of Chinese herbal medicines and Chinese herbal decoction pieces that are subject to approval and management shall be formulated by the drug regulatory department in conjunction with the competent department of traditional Chinese medicine. To apply for drug registration, true, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of the drug.

Article 25 For the drugs applied for registration, the drug regulatory department shall organize pharmacical, medical and other technical personnel to conduct a review to review the safety, effectiveness and quality controllability of the drug, as well as the applicant's ability of quality management, risk prevention and control, and liability compensation; If the conditions are met, a drug registration certificate will be issued. When approving drugs, the drug regulatory department shall review and approve the chemical raw materials, the relevant excipients, packaging materials and containers in direct contact with the drug, and the quality standards, production processes, labels and instructions of the drugs. The term "excipients" in this Law refers to the excipients and additives used in the production of drugs and the preparation of prescriptions.