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《中华人民共和国药品管理法》第二十三条规定“国务院卫生行政部门颁布的《中华人民共和国药典》和药品标准为国家药品标准”,“国务院卫生行政部门的药典委员会,负责组织国家药品标准的制订和修订”,从国家法律上明确药典会是负责组织制、修订药典和国家药品标准的专业机构,是属标准化工作范畴.为了做好药品标准工作,除根据卫生工作的方针政策外,还应遵循国家标准工作的方针、政策、原则,并须了解标准和标准化的含义、性质和作用等.
Article 23 of the “Drug Administration Law of the People’s Republic of China” stipulates that “the Pharmacopoeia of the People’s Republic of China and the pharmaceutical standards shall be the national drug standards promulgated by the health administrative department under the State Council” and that "the Pharmacopoeia Commission of the State Council administrative department of health should be responsible for organizing the national drug standards The formulation and revision of the national laws from the Pharmacopoeia is a responsible organization, revision of Pharmacopoeia and national pharmaceutical standards of professional bodies, is a standardization of work areas.In order to do a good job in drug standards, in addition to the basis of health work guidelines and policies, They should also follow the guidelines, policies and principles of national standard work and must understand the meaning, nature and function of standards and standards.