Regulations

Track-and-trace regulations around the world represent a complex and ever-evolving set of requirements based on where you operate and what sort of pharmaceuticals you manufacture, distribute or dispense. Read on to learn more.

Around the world, countries are introducing new legislation aimed at preventing counterfeit and harmful goods from entering the global supply chain. These new rules, necessary to boost public safety and confidence in global markets, show broad adoption of end-to-end traceability, embracing the notion that any single product should be fully traceable from its manufacturer down through distribution channels to retailers, health systems, pharmacies, and other public-facing businesses. However, such rules aren’t always easy to implement or follow. Some of these regulations outline systems, solutions, or methods of collaboration that have not been fully developed, are not immediately accessible to industry, or are difficult to roll out at-scale. Often, businesses struggle to understand their new responsibilities even as they commit staff hours to implementing them, a position that can incur additional costs and hurt productivity – without certainty of protection from regulatory penalties or reputational damage.

探索全球药品追踪法规

使用下面的交互式地图查看跟踪和追踪世界各地的法规。将鼠标悬停在任何国家或地区上,查看当前针对该地区药品分销的合规要求和监管框架。

贴标签

贴标签

产品必须以书面形式显示信息。

批次级别

批次级可追溯性

产品可作为唯一识别批次的一部分进行追踪。

单位级别

单位级可追溯性

可售商品采用唯一标识,从而实现更精细的可追溯性。

聚合

聚合

需要识别和记录产品的包装层次结构。

中央报告

中央报告

可追溯性文件必须集中在一个独特的系统中。

LSPedia Connected Country

LSPedia Connected Country

Countries that are already connected with LSPedia's Data Hub

Argentina
ANMAT
Armenia
Armenia
Australia
TGA
Azerbaijan
Azerbaijan
Bahrain
NHRA
Brazil
ANVISA
Canada
Canada
China
NMPA
Colombia
Colombia
Egypt
CAPA
Ethiopia
Ethiopia
European Union
EU FMD
Ecuador
Ecuador
India
Active Ingredient Verification
India
IVEDA
Iran
TTAC
Iraq
Iraq
Indonesia
BPOM
Japan
Japan
Kazakstan
National System of Traceability of Goods
Lebanon
MediTrack
Lebanon
MediTrack
Malaysia
Malaysia
Nigeria
Nigeria
Oman
Oman
Pakistan
Pakistan
Philippines
Philippines
Russia
Chestnye Znak
Rwanda
Rwanda FDA
Saudi Arabia
Saudi Arabia
Sri Lanka
NMRA
Southern Africa
AMA
South Africa
South Africa
South Korea
South Korea
Serbia
Serbia
Türkiye
ITS
美国
DSCSA
UAE
Tatmeen
Uzbekistan
ASL BELGISI
Zambia
ZAMBRA

快速链接

美洲

通过 LSPedia 探索美洲各地的药品法规。从具有里程碑意义的美国 DSCSA 到例外试点等,我们的综合资源中心可让您随时了解动态制药领域的合规标准。

欧洲

借助LSPedia的专用资源中心,保持欧洲药品法规的领先地位。从欧盟口蹄疫到食品和烟草法规以及 EMVO SDK,我们的全面内容可确保在充满活力的欧洲市场中保持合规性。

中东非洲

LSPedia 为中东和非洲的药品法规提供了全面的指南。从埃塞俄比亚的EFDA到土耳其的ITs,我们的资源使您随时了解这些快速发展的市场的合规标准。

亚太地区

LSPedia的亚太监管中心提供对韩国、中国和印度(CDSCO)药品法规的见解。利用我们全面的资源,在这些多元化的市场中保持合规。

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