sevenspikes.themes.common.filters
sevenspikes.themes.common.closemenu

欧洲药典EP标准品

点此→【联络技术支持与销售】

欧洲药典EDQM Ph. Eur. EP标准品:欧洲药品和医疗保健质量管理局(EDQM)致力于在整个欧洲实现安全药品质量标准的统一。

欧洲药品和医疗保健质量管理局(EDQM)成立于1964年,总部位于法国斯特拉斯堡。主要负责欧洲药典EP的编纂制定并提供各类标准物质,EDQM雇用了来自28个国家的数百名员工,由九个实体组成。只有符合欧洲药典(Ph.Eur.)质量要求的药品,才能被允许进入其38个成员国的市场进行销售,EDQM致力于在整个欧洲实现安全药品质量标准的统一。除成员国外,EDQM还有30个观察员,分别来自各大洲28个国家,台湾食品药品监督管理局(TFDA),福利机构和世界卫生组织(世卫组织)。

【欧洲药典EP标准品中国总代理:北实纵横科学公司】

欧洲药典EDQM Ph. Eur. EP标准物质

欧洲药品和卫生保健质量局(EDQM)是欧洲委员会的理事会(民主总局(DGII)),负责制定具有法律约束力的优质药品质量标准。此外,EDQM还制定了输血,器官,细胞和组织移植以及消费者健康领域的指导和标准。EDQM由一名董事领导,由九个实体组成。 EDQM在其工作中依赖于其指导委员会的专家网络和专家组。为了维持其使命并确保向其利益相关者提供高水平的交付成果,EDQM以ISO 9001认证的质量管理体系为基础进行运作。


欧洲药典EDQM Ph. Eur. EP标准物质

欧洲药典EDQM Ph. Eur. EP标准物质


化学参考物质(CRS), 草药参考标准(HRS)

欧洲药典EDQM Ph. Eur. EP标准物质
欧洲药典EDQM Ph. Eur. EP标准物质
欧洲药典EDQM Ph. Eur. EP标准物质


生物参考制剂(BRP),生物制剂标准品, 制药标准品

欧洲药典EDQM Ph. Eur. EP标准物质
欧洲药典EDQM Ph. Eur. EP标准物质
欧洲药典EDQM Ph. Eur. EP标准物质


欧洲药典EDQM Ph. Eur. EP标准物质

European Pharmacopoeia (Ph. Eur.)

1991年,欧洲共同体委员会与欧洲委员会签订了一项合同,以便为与生物医药产品(通常称为生物制剂)特别是疫苗和血液的检测有关的活动提供后勤和科学援助。

该合同涵盖在指导委员会下实施的生物标准化计划(BSP)中的研究活动。秘书处由EDQM的生物标准化,OMCL和卫生保健部(DBO)提供。

生物标准化计划由两个缔约方提供的特定预算供资。此后,欧洲共同体委员会正式成为《制定欧洲药典》的缔约国,并继续每年继续提供财政捐助。非欧盟国家也可以提供财政捐助。为了提高国际协调性,在可能的情况下,在BSP下进行的合作研究还应与世界卫生组织(WHO)和美国食品药品管理局(FDA)计划和实施的研究进行协调。

完成的合作研究的完整报告发表在“ Pharmeuropa生物与科学笔记”中。

该合同通过补充欧洲药典委员会相关专家组的工作,为生物领域的活动提供了新的动力。


EDQM背景

A contract was signed in 1991 between the Commission of the European Communities and the Council of Europe to allow for the provision of logistical and scientific assistance for activities related to the testing of biological medicinal products (commonly known as biologicals) in particular vaccines and blood.

This contract covers research activities within the Biological Standardisation Programme (BSP) implemented under a Steering Committee. The Secretariat is provided by the Biological Standarisation, OMCL and HealthCare Department (DBO) of the EDQM.

The Biological Standardisation Programme is financed by a specific budget contributed by the two contracting parties. The Commission of the European Communities has since officially become a party to the Convention on the Elaboration of a European Pharmacopoeia and has been continuing to make a financial contribution every year. Non-EU countries may also make a financial contribution. To improve international harmonisation, whenever possible, collaborative studies run under the BSP are also co-ordinated with those planned and carried out by the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA).

The full reports of the concluded collaborative studies are published in ‘Pharmeuropa Bio & Scientific Notes'.

This contract has given new impetus to activities in the biological field by complementing the work performed by the relevant groups of experts of the European Pharmacopoeia Commission.


EDQM使命

The mission of the BSP is to:

  • elaborate European Pharmacopoeia Reference Standards and working standards for biologicals (i.e. biological reference preparations [BRP] and chemical reference substances [CRS])
  • standardisation of test methods for the quality control of biologicals;
  • elaborate alternative methods for the quality control of biologicals in order to apply the 3Rs concept (Refine, Reduce, Replace) to use of animals in laboratory experiments
  • contribute to the activities of the International Conference on Harmonisation (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) in the field of biologicals.