Counterfeit medicines have long been a topic with global implications, which countries are countering with legal regulations, among other things. Raw materials come from China or India, the subsidiaries are in Europe and the USA, and the drugs are distributed worldwide. Due to the global networking of the pharmaceutical industry, internationally active companies must comply with very different laws to achieve global compliance.

Worldwide, the pharmaceutical industry is one of the most heavily regulated industries. The companies’ international trade connections also give rise to global responsibility, demanded by the countries’ legislation. One aspect is the safety of medicines. Groups of states, such as Europe, or individual countries, like the USA or Russia, are actively fighting against counterfeit drugs. More and more countries are now working on making their medicines more transparent and thus safer supply chains through track-and-trace and similar measures. Since 2019, European pharmaceutical companies are only allowed to put serialized Rx drugs into circulation (legislation: EU-FMD). 

Achieving global compliance in the pharmaceutical industry requires robust serialization and verification systems. Serialization assigns a unique identifier to every prescription medicine package, enabling full traceability across the supply chain, from manufacturing to dispensing. This process ensures authenticity, prevents counterfeit drugs, and supports rapid recalls when necessary. Regulatory frameworks like the EU-FMD in Europe, the DSCSA in the United States, and Russia’s Chestny ZNAK system are prime examples of global compliance initiatives. Together, these measures create transparent, secure, and interoperable supply chains, safeguarding patient safety worldwide.

Country-Specific Serialization Requirements

Growing and specific regulations do not make it easy for pharmaceutical companies. Above all, large and small companies must meet identical requirements. It becomes increasingly complex to meet the regulations, depending on how many and which regions of the world a company is active in. Around 80% of the world’s governments are working on implementing pharmaceutical serialization to combat counterfeit drugs and fraud. Currently, the EU, Russia, USA, China, South Korea, and others have specific serialization requirements for the pharmaceutical industry that pharmaceutical companies must comply with when selling their drugs in these regions. Other countries will follow/or have already followed, and introduce their guidelines. These include Saudi Arabia, Abu Dhabi, and Brazil.

For pharmaceutical companies, this means building flexible compliance strategies that can adapt to evolving global standards. Implementing serialization across multiple markets is not just a technical challenge. It requires harmonizing processes, IT systems, and data exchange with diverse regulatory frameworks. Companies must invest in scalable solutions that support different coding formats, reporting requirements, and verification systems. Those who act early and establish robust global compliance programs will gain a competitive advantage, ensuring uninterrupted market access and safeguarding patient trust worldwide.

More Information About Individual Regulations

• Pharma Serialization Regulations of the UAE: Abu Dhabi
• Pharma Serialization in Argentina
• Pharma Serialization in China
• Brazil Pharmaceutical Serialization Regulations
• Indonesia: Pharma Serialization Regulations
• Track-and-Trace in Saudi Arabia

Get Global Compliance for Pharma with tracekey

Pharmaceutical companies face increasing pressure to meet diverse serialization and track-and-trace regulations worldwide. With tracekey, achieving global compliance becomes simple and efficient. Our cloud-based solutions help you manage complex requirements across regions like the EU, USA, Russia, and emerging markets such as Saudi Arabia and Brazil. From unique serial number generation to seamless data reporting, tracekey ensures transparency, security, and interoperability in your supply chain. Stay ahead of regulatory changes and protect patient safety with a partner that understands global compliance challenges.