Overview of the British pharmaceutical standard-setting system
10.3969/j.issn.1674-2982.2014.09.008
- VernacularTitle:英国药品标准法律制度评介
- Author:
Jinjing YANG
;
Hualin SONG
- Publication Type:Journal Article
- Keywords:
Pharmaceutical standards;
British Pharmacopoeia;
British law;
Administrative law
- From:
Chinese Journal of Health Policy
2014;(9):48-53
- CountryChina
- Language:Chinese
-
Abstract:
The paper presents a detailed review of British pharmaceutical standards including British Pharma-copoeia, European Pharmacopoeia, British Approved Names, Reference Standards and Non-Statutory Pharmaceutical Standards. British pharmaceutical standards are established by the British Pharmacopoeia Commission, Expert Advi-sory Groups, Panels of Experts and Working Parties, British Pharmacopoeia Commission Secretariat, British Pharma-copoeia Laboratory, and standard-setting procedures are clear and definite. British Pharmacopoeia standards are le-gally binding, and pharmaceutical products sold in the United Kingdom must comply with pharmacopoeia require-ments. British pharmaceutical standards can serve as an important reference for reforms to China’s pharmaceutical standards, including the scientific management of pharmaceutical standards, the improvement of organizational frame-works in the establishment pharmaceutical standards, the promptness of amendments to pharmacopoeia, and the uni-versality of international exchanges.
