欧洲

驾驭监管格局:欧洲法规和相关链接的中心枢纽

Navigating the Regulatory Landscape

This page serves as a centralized resource for exploring pharmaceutical regulatory requirements across EU member states. Each country listed below features a summary of its compliance landscape along with a link to more detailed information. This hub supports visibility into region-wide mandates such as the Falsified Medicines Directive (FMD), offering a clear view of how regulations are structured and enforced across Europe.

All Regulations

欧盟 FMD

LSPedia 的欧盟口蹄疫资源指导您了解《欧洲伪造药品指令》的复杂性。遵守我们的见解,确保您的制药业务符合欧洲监管标准。

俄罗斯的 Chestnye Znak

在俄罗斯,Chestny ZNAK系统代表了一个全面的国家跟踪和追踪框架,旨在确保药品真实性并打击假冒药物。这一强大的监管体系于2017年12月根据第425-FZ号联邦法律建立,自2019年以来已分阶段实施,创建了世界上最严格的药品追溯网络之一,旨在保护公共健康和确保供应链完整性。

哈萨克斯坦的药品供应链

在哈萨克斯坦,商品标记和可追溯信息系统(IS MPT)是该国确保药品完整性的综合框架。该集中式数字系统由哈萨克斯坦电信股份公司运营,采用先进的跟踪技术来打击假冒药物,提高供应链透明度,并保护全国制药领域的公共健康。

Armenia

Armenia stands at the forefront of pharmaceutical supply chain modernization through its comprehensive e-Mark electronic marking system. As a member of the Eurasian Economic Union (EAEU), Armenia is strategically developing its track and trace regulatory framework to align with international standards while ensuring robust protection against counterfeit medicines. The country's phased approach to implementation demonstrates a commitment to building a transparent and secure pharmaceutical ecosystem that safeguards public health through advanced digital oversight mechanisms.

塞尔维亚

塞尔维亚建立了完善的药品监管体系,通过先进的可追溯性措施和防伪协议将患者安全放在首位。塞尔维亚的监管框架建立在1993年《塞尔维亚药品法》的基础上,符合欧洲标准,确保从制造商到患者对药品进行全面监测,在增强快速反应能力的同时,为假药提供强有力的防御措施。

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