How to write the correct drug approval number and what is the drug approval number

The format of the drug approval number is: national drug quasi-word H (z, S, J) + four-digit year number + four-digit sequence number, where H represents chemical drugs, Z stands for traditional Chinese medicine, S stands for biological products, and J stands for imported drugs for sub-packaging.

Generally, it is the beginning of the quasi-word of Chinese medicine, divided into traditional Chinese medicine and chemical medicine, Chinese pharmacist z, chemical medicine is h, and the following is the number.

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.

The letters of the drug approval number include H, Z, S, B, T, F, and J. Each letter represents different categories of drugs: h stands for chemical drugs; z stands for proprietary Chinese medicine; S stands for biological products; b stands for health medicine; t stands for in vitro chemical diagnostic reagent; f represents pharmaceutical excipients; j stands for Imported Sub-packaged Drugs.

Expand knowledge: The quasi-word of Chinese medicine is the drug production approval number obtained by the drug production unit after strict approval by the State Food and Drug Administration before the production of new drugs, which is equivalent to a person's ID card. Its format is the standard word of Chinese medicine + 1 letter + 8 digits, of which the letter used in chemicals is H, the letter used in traditional Chinese medicine is Z and so on. Only with this approval number can drugs be produced and sold.

For example, if the approval number of a drug in 2000 was "Wei Yao Zhun Zi (1997) X-01 (1)", then it is now reissued as "Guoyao Zhun Zi H10970001". Another example is "H" in "National Medicine Quasi-word H11020001" in which "H" represents chemicals, "11" is the first two digits of Beijing's administrative division, "02" is the last two digits of 2002, the year of reissuance, and "0001" is the new sequence number.