Letter meaning of drug approval number

The letters of drug approval number include h, Z, s, B, t, F and J. Each letter represents different categories of drugs: H represents chemicals; Z stands for Chinese patent medicine; S stands for biological products; B represents health drugs; T stands for in vitro chemical diagnostic reagent; F stands for pharmaceutical excipients; J stands for imported sub packaged drugs.

Letter meaning of drug approval number

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The national drug approval number is the drug production approval number obtained by the drug production unit after strict examination and approval by the State Food and drug administration before the production of new drugs, which is equivalent to the person's ID card. The format is Guoyao Zhunzi + 1 letter + 8 digits, in which the letter used for chemical drugs is h, the letter used for traditional Chinese medicine is Z, etc. Only after obtaining this approval number can drugs be produced and sold.

Letter meaning of drug approval number

For example, if the approval number of a drug in 2000 was "wyzz (1997) x-01 (1)", it is now replaced with "gyzz h10970001". For another example, "H" in "gyzz h11020001" indicates chemicals, "11" is the first two digits of Beijing administrative division code, "02" is the last two digits of 2002, the year of renewal, and "0001" is the new sequence number.

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