What is the approval number of the drug?
The approval number of a drug is the only identifier that the national drug regulatory department has approved for marketing of a drug produced by a drug manufacturer. It is similar to the "ID card" of a drug. It is an important basis for the legality of drugs. Consumers can check the authenticity and production information of drugs through the approval number. In recent years, drug safety issues have attracted much attention, and understanding the meaning of approval numbers and query methods is crucial to ensuring drug safety.
1. The composition and meaning of the approval number
Drug approval numbers usually consist of letters and numbers, and the format varies by country or region. Taking China as an example, the format of the approval number is as follows:
| Document number type | Format example | meaning |
|---|---|---|
| Domestic drugs | National drug approval number H (Z/S/J) + 8 digits | H represents chemical drugs, Z represents traditional Chinese medicine, S represents biological products, and J represents imported subpackaged drugs. |
| Imported medicines | Imported drug registration certificate number H (Z/S) + 8 digits | H, Z, S classifications are consistent with domestic drugs |
For example, "National Drug Approval Number H20220001" means that the drug is a chemical drug, approved in 2022, and the serial number is 0001.
2. How to check the drug approval number
Consumers can verify drug approval numbers through the following official channels:
| Query method | Operation steps |
|---|---|
| State Food and Drug Administration official website | Enter the "Drug Query" column and enter the approval number or drug name |
| "China Drug Supervision" APP | Download the official APP, scan the drug packaging barcode or enter the document number manually |
| Third party platform | Some e-commerce platforms (such as Alibaba Health and JD Health) provide drug information query functions |
3. Hot issues regarding approval number
In the past 10 days, discussions on drug approval numbers have mainly focused on the following aspects:
| hot topics | Specific content |
|---|---|
| Online drug sales supervision | "Internet celebrity drugs" without approval numbers have been exposed in many places, reminding consumers to pay attention to verification |
| Chinese medicine formula granules | New regulations require traditional Chinese medicine formula granules to be marked with approval numbers to promote industry standardization |
| Medication safety for children | Some children's antipyretics have been recalled due to expired registration numbers. Parents need to check the expiry date. |
4. The importance of approval number
1.Legality guarantee: Drugs without approval numbers may be counterfeit or illegally produced, posing safety risks.
2.Quality traceability: The manufacturer, batch and ingredient information of the drug can be queried through the document number.
3.Basis for rights protection: If drug problems are discovered, the approval number is the key document for complaints or claims.
5. Summary
Drug approval number is the “first line of defense” for drug safety. When consumers purchase medicines, they must check the validity and authenticity of the registration number and give priority to formal channels. The State Food and Drug Administration has also recently stepped up its efforts to crack down on fake registration numbers. In the future, it will further optimize the query system and enhance the transparency of drug supervision.
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