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.

Explore Global Pharmaceutical Track & Trace Regulations

Use the interactive map below to view track and trace regulations around the world. Hover over any country or region to see current compliance requirements and regulatory frameworks specific to pharmaceutical distribution within that area.

Labelling

Labelling

Products are required to display information in writing.

Lot Level

Lot Level Traceability

Products are traceable as part of uniquely identified lots.

Unit Level

Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

Aggregation

Aggregation

The packaging hierarchy of products is required to be identified and documented.

Central Reporting

Central Reporting

The traceability documentation is required to be centralized in a unique system.

LSP Shield logo representing security and protection in pharmaceutical supply chain
LSPedia Connected Country

LSPedia Connected Country

Countries that are already connected with LSPedia's Data Hub

LSP Shield logo representing security and protection in pharmaceutical supply chainArgentinian flag with light blue and white stripes and sun
Argentina
ANMAT
Armenia
Armenia
Australian flag with Union Jack and southern cross stars
Australia
TGA
Azerbaijan
Azerbaijan
Bahrain flag with red and white serrated edge
Bahrain
NHRA
LSP Shield logo representing security and protection in pharmaceutical supply chainBrazilian flag with green background yellow diamond and blue globe
Brazil
ANVISA
Canadian flag with red and white maple leaf
Canada
Canada
LSP Shield logo representing security and protection in pharmaceutical supply chainChinese flag with red background and yellow stars
China
NMPA
LSP Shield logo representing security and protection in pharmaceutical supply chain
Colombia
Colombia
LSP Shield logo representing security and protection in pharmaceutical supply chainEgyptian flag with red white and black stripes and gold eagle
Egypt
CAPA
Ethiopia
Ethiopia
LSP Shield logo representing security and protection in pharmaceutical supply chainEuropean Union flag with circle of yellow stars
European Union
EU FMD
Ecuador
Ecuador
LSP Shield logo representing security and protection in pharmaceutical supply chainIndian flag with orange white and green stripes and blue wheel
India
Active Ingredient Verification
LSP Shield logo representing security and protection in pharmaceutical supply chainIndian flag with orange white and green stripes and blue wheel
India
IVEDA
Iranian flag with green white and red horizontal stripes and emblem
Iran
TTAC
Iraq
Iraq
LSP Shield logo representing security and protection in pharmaceutical supply chainIndonesian flag with red and white horizontal stripes
Indonesia
BPOM
Japan
Japan
LSP Shield logo representing security and protection in pharmaceutical supply chainKazakhstan flag with blue background and yellow sun design
Kazakstan
National System of Traceability of Goods
LSP Shield logo representing security and protection in pharmaceutical supply chainKyrgyzstan flag thumbnail
Kyrgyzstan
Lebanese flag with red white and green cedar tree
Lebanon
MediTrack
Lebanese flag with red white and green cedar tree
Lebanon
MediTrack
Malaysia
Malaysia
Nigeria
Nigeria
Oman
Oman
Pakistan
Pakistan
Philippines
Philippines
LSP Shield logo representing security and protection in pharmaceutical supply chainRussian flag with white blue and red horizontal stripes
Russia
Chestnye Znak
Rwanda flag with blue yellow and green stripes and sun symbol
Rwanda
Rwanda FDA
LSP Shield logo representing security and protection in pharmaceutical supply chain
Saudi Arabia
Saudi Arabia
Sri Lankan flag with lion and colored stripes
Sri Lanka
NMRA
Southern African Development Community logo with text Towards a Common Future
Southern Africa
AMA
South Africa
South Africa
LSP Shield logo representing security and protection in pharmaceutical supply chain
South Korea
South Korea
Serbia
Serbia
LSP Shield logo representing security and protection in pharmaceutical supply chainTurkish flag with red background white crescent and star
Türkiye
ITS
USA
DSCSA
LSP Shield logo representing security and protection in pharmaceutical supply chainUnited Arab Emirates flag with red green white and black stripes
UAE
Tatmeen
LSP Shield logo representing security and protection in pharmaceutical supply chainUzbekistan flag thumbnail
Uzbekistan
ASL BELGISI
Zambian flag with green background eagle and colored stripes
Zambia
ZAMBRA

Quick links

Americas

Explore pharmaceutical regulations across the Americas with LSPedia. From the landmark US DSCSA to Exceptions Pilot and beyond, our comprehensive resource hub keeps you informed about compliance standards in the dynamic pharmaceutical landscape.

Europe

Stay ahead of European pharmaceutical regulations with LSPedia's dedicated resource hub. From EU FMD to Food & Tobacco regulations and the EMVO SDK, our comprehensive content ensures compliance in the dynamic European market.

Middle East Africa

LSPedia provides a comprehensive guide to pharmaceutical regulations in the Middle East and Africa. From Ethiopia's EFDA to Turkey's iTS, our resources keep you informed about compliance standards in these rapidly evolving markets.

Asia Pacific

LSPedia's Asia Pacific Regulatory Hub provides insights into pharmaceutical regulations across South Korea, China, and India (CDSCO). Stay compliant in these diverse markets with our comprehensive resources.

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