宁波亚川生物医药有限公司
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EU将在6个月内实施药品识别标准

Identification of Medicinal Products Standards will apply in six Months
药品识别标准将在6个月内实施

Over the last couple of years the European Health Authorities in conjunction with the International Standards Organization (ISO) have been developing a set of global data standards referred to as Identification of Medicinal Products (IDMP). 
在过去几年间,欧洲卫生管理局与国际标准组织(ISO)一起开发了一系列的全球数据标准,被称为药品识别(IDMP)标准。

The Identification of Medicinal Products (IDMP) standards were developed in response to a worldwide demand for internally harmonized specifications for medicinal products. The EU is the first to implement these standards, and the other ICH regions will follow. The pharma sector must comply with IDMP standards in the EU region starting July 2016. Following the EU, the other ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) countries will then begin their own adoption processes to ensure global compliance. 
药品识别(IDMP)标准在根据全球药品协调规范要求开发的。EU是第一个实施这些标准的地区,其它ICH地区将随后实施。自2016年7月起,EU地区的药品部分必须遵守IDMP标准,其它ICH国家之后要启动自己国家的采用流程,确保全球符合性。

Once the IDMP standards are implemented globally, detailed information about all medicinal products worldwide will, for the first time, be available in a consistent format. This provides regulators with the means of easily comparing product data across regions and with different manufacturers and marketing authorisation holders. This increased transparency will drive numerous patient safety initiatives. It also paves the way for the future roll-out of patient-centric initiatives such as 'e-prescriptions'. 
一旦IDMP标准在全球实施,所有全球药品详细信息将首次以统一格式让人们获取。这使得法规工作者、不同生产商和上市许可持有人能够很容易地将不同地区的药品数据进行比较。这种方式增加的透明度将保护无数患者的安全。它还会为未来全面推行患者自主中心,如“电子处方”铺平道路。

Adopting the IDMP standard should not only help to achieve regulatory compliance but wants also improve internal business process efficiencies, as well as increase effectiveness between business functions and with external partners, truly enabling a task to value strategy. 
采用IDMP标准不仅能帮助达到法规符合性,还可以改善国际业务进度有效性,以及增加业务功能和外部伙伴之间的有效性,真正将任务推进成为一个产生价值的策略。

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