The national drug approval character H represents chemical drugs, and the national drug approval character Z represents Chinese patent medicines. The distinction is based on the first pinyin letter of the first word of the drug type. The specific classification types are introduced:

1 , H represents chemicals, including the following types:

1. APIs and their preparations prepared by synthetic or semi-synthetic methods.

2. New effective monomers and their preparations extracted from natural substances or through fermentation.

3. Optical isomers and preparations of known drugs prepared by separation or synthesis.

4. Prepare drugs with fewer components from multi-component drugs that are already on the market.

5. New compound preparations.

2. Z represents Chinese patent medicines, including the following types:

1. Two or more Chinese patent medicines with similar effects are used together to enhance the efficacy of the medicine.

2. Chinese patent medicines with different efficacies can be used together. One drug is the main drug and the other is the auxiliary drug. The auxiliary drugs can improve the main effect.

3. One of the drugs can significantly inhibit or eliminate the bias or side effects of another proprietary Chinese medicine.

4. Some Chinese patent medicines are also compatible because different treatment methods must be used to treat some diseases.

3. The letters include H, Z, S, B, T, F, and J, which represent different categories of drugs:

1. H represents chemicals,

2. Z represents Chinese patent medicines,

3. S represents biological products,

4. B represents health care drugs,

5. T represents in vitro chemistry Diagnostic reagents,

6. F represents pharmaceutical excipients,

7. J represents imported sub-packaged drugs.

Extended information

Legal provisions:

"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 of the State Council and issued with a drug approval number; however, the production of Chinese herbal medicines and Chinese herbal pieces that are not subject to approval number management is excepted. The catalog of Chinese herbal medicines and Chinese herbal pieces subject to approval number management shall be formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine management department of the State Council. Drug manufacturers can only produce the drug after obtaining the drug approval number.

Article 32: Drugs must comply with national drug standards. Traditional Chinese medicine preparations shall be made in accordance with the provisions of paragraph 2 of Article 10 of this Law. The Pharmacopoeia of the People's Republic of China and the Drug Standards promulgated by the Drug Supervision and Administration Department of the State Council are national drug standards. The drug regulatory department of the State Council organizes the Pharmacopoeia Committee, which is responsible for the formulation and revision of national drug standards. The drug inspection agency of the drug regulatory department of the State Council is responsible for the calibration of national drug standards and reference materials.

Baidu Encyclopedia - Chinese Patent Medicines (Chinese Herbal Medicines)

Baidu Encyclopedia - Chemical Drugs

Baidu Encyclopedia - Approval Number

Baidu Encyclopedia -National Drug Approval