Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products
- VernacularTitle:《药品标准管理办法》解读与思考
- Author:
Mengxia ZHAO
1
;
Lina SUN
2
;
Dan XU
3
;
Wen CHAI
4
;
Xuekong JIANG
4
;
Zhihai MAO
5
;
Shengliang HE
3
Author Information
1. School of Public Health and Nursing，Medical College，Hubei University of Science and Technology，Hubei Xianning 437100，China
2. Evaluation Center of Hubei Provincial Drug Administration，Wuhan 430071，China
3. Xian’an District Public Inspection and Testing Center of Xianning，Hubei Xianning 437000，China
4. Xianning Branch of Hubei Provincial Drug Administration，Hubei Xianning 437100，China
5. Zhen’ao Jinyinhua Pharmaceutical Co. Ltd.，Hubei Xianning 437000，China
- Publication Type:Journal Article
- Keywords:
Measures for the Administration of Standards for Medicinal Products;
drug standard code;
drug registration
- From:
China Pharmacy
2024;35(7):783-786
- CountryChina
- Language:Chinese
-
Abstract:
In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.
