Author: Vivian Xie 21st May 2026

As technological advances have made seismic changes to the pharmaceutical sector, no element of the industry has been left untouched, and labelling is no exception. What was once a straightforward process of printing product information has evolved into a complex, discipline that sits at the intersection of patient safety, regulatory compliance and supply chain security. And this is only becoming more intricate as counterfeit medicines become increasingly widespread and regulations become more strict across multiple jurisdictions.

For global pharmaceutical organisations, the stakes have never been higher. Failing to comply with labelling regulations can result in product recalls, market access delays, substantial financial penalties and irreparable damage to brand reputation. Yet achieving compliance across the multiple international markets European Union, China, India, and other major markets requires navigating a labyrinth of serialisation mandates, track-and-trace requirements and everchanging regulatory frameworks.

The impact of the EU’s falsified medicines directive

Implemented in February 2019, the Falsified Medicines Directive (FMD) was devised by the European Union as a fundamental reshaping of the continent’s pharmaceutical labelling measures. It was brought into action alongside the European Medicines Verification System (EMVS), which requires unique identifiers and anti-tampering devices on prescription medicine packaging throughout the EU.

According to the European Medicines Verification Organisation, [1] the system has verified over 8 billion medicine packs since being put in place, bringing about an unprecedented level of transparency to the continent’s supply chain. However, as directive continue to evolve, compliance remains an ongoing challenge. Recent FMD updates have expanded coverage to include additional product categories and tightened verification protocols, requiring manufacturers to update their labelling systems accordingly.

The technical requirements behind this are substantial and not necessarily simple to implement; each medicine pack must carry a unique identifier, which consists of a product code, serial number, national reimbursement number, expiry date and batch number, all encoded in a 2D Data Matrix barcode. Additionally, an anti-tampering device must provide visible evidence of whether the packaging has been opened. These requirements demand sophisticated labelling systems capable of generating, printing, and verifying millions of unique codes whilst maintaining production line efficiency.

Beyond the EU's borders, the United Kingdom's post-Brexit regulatory landscape has only added to the complexity. Despite initially maintaining an alignment with FMD requirements, the UK’s the Medicines and Healthcare products Regulatory Agency (MHRA) has signalled potential divergence in the future, which will require flexible labelling solutions that can accommodate multiple regulatory frameworks simultaneously.

China's evolving serialisation landscape

China represents one of the world's fastest-growing pharmaceutical markets, but market access requires an understanding of how to meet the National Medical Products Administration (NMPA)’s myriad regulations. The NMPA has implemented comprehensive drug serialisation requirements designed to combat the country's significant counterfeit medicine problem.

China's Drug Traceability System, [2] mandated under the 2019 Drug Administration Law, requires pharmaceutical companies to establish electronic tracking measures which covering the entire supply chain, from manufacturing through to dispensing. The system demands unique product identifiers at multiple levels, as well as real-time data uploads to government databases, and comprehensive record-keeping throughout the distribution network.

The technical specifications differ significantly from those in Europe. China's system uses a 20-digit tracking code that must be registered with the Chinese FDA’s database before products enter market. According to industry analysis, [3] manufacturers must integrate their labelling systems with Chinese regulatory databases, requiring specialised technical capabilities and local partnerships to ensure seamless data transmission and compliance verification.

There is also the small matter of language. All of the country’s pharmaceutical labelling must include Chinese-language information meeting specific formatting and content requirements, whilst many manufacturers also need to maintain multilingual labelling for products distributed across multiple Asian markets. This necessitates sophisticated labelling management systems which can handle complex character sets as well as ensure that all technical and regulatory content is correctly translated and localised.

With a brand-new zone on the show floor dedicated exclusively to labelling, CPHI Milan 2026 will address this, and many of pharma’s other major challenges, head-on. As the destination for the international pharmaceutical sector, these regulatory issues will undoubtedly be a hot topic at this year’s show, so read on for an overview of some the significant differences between the labelling regulations across the world’s major pharma markets.

India's track-and-trace mandates

India's pharmaceutical sector supplies approximately 20% of the world’s generic medicines, so it’s little surprise that its labelling regulations are especially comprehensive. The Central Drugs Standard Control Organisation (CDSCO) has mandated a track-and-trace framework  which stipulates that all pharmaceutical products be serialised in order to address concerns around supply chain integrity and counterfeitting.

India's track-and-trace regulations require unique product identification codes for all saleable units, with aggregation data linking individual units to secondary and tertiary packaging. The system demands that all manufacturing, distribution and dispensing events be reported in real-time to a centralised database, creating an end-to-end visibility framework across the entirety of India's complex pharmaceutical supply chain with many local companies beginning to focus on future innovations such as AI traceability. [4]

Implementation timelines have been phased, subjecting different product categories to different compliance deadlines in order to avoid a bottleneck. Recent regulatory updates [5] have accelerated timelines for higher-risk categories and provided extended implementation periods for smaller manufacturers. This staggered approach creates challenges for multinational companies that must maintain compliance across multiple product portfolios whilst managing varying deadlines and technical requirements.

The Indian market's unique distribution characteristics further complicate compliance. With thousands of distributors, wholesalers, and retail pharmacies operating across diverse geographic regions, ensuring consistent data capture and reporting throughout the supply chain requires robust technical infrastructure and extensive stakeholder engagement. Labelling solutions must accommodate India's specific barcode standards, database integration requirements and reporting protocols, while remaining compatible with international serialisation frameworks.

Multi-market compliance and the challenges of integration

Pharmaceutical companies operating on a global level may be capable of taking individual market requirements in their stride. However, developing solutions for integrated pharmaceutical labelling compliance that accommodate multiple regulatory frameworks at once is an entirely different proposition. Products destined for European, Chinese, and Indian markets may require different serialisation formats, data content and barcode symbologies, as well as market-specific language requirements, all while still maintaining production efficiency and cost-effectiveness.

Manufacturers face significant technical and operational challenges in aligning their labelling systems across markets. For example, coordinating artwork can become exponentially more complex once language variations and market-specific content are taken into account. Production line flexibility must be able to accommodate rapid changeovers between different labelling configurations without compromising speed or accuracy, while data management systems must be able to integrate with multiple national databases without sacrificing data integrity or security.

The financial implications of these compliance measures are substantial. Industry estimates suggest [6] that the move to global serialisation has cost the pharmaceutical industry billions in infrastructure investments, system integration and ongoing operational expenses. However, non-compliance costs like product recalls, market access delays and regulatory penalties far exceed the investment required for robust labelling solutions.

Preparing for future regulatory evolution at CPHI Milan

CPHI Milan's new Labelling Zone provides pharmaceutical manufacturers with the insights, technologies, and partnerships they need to navigate this evolving landscape. By connecting with the solution providers at the forefront of labelling innovation, companies can develop flexible, scalable approaches that accommodate current requirements whilst positioning them for future regulatory changes.

Beyond the technology itself, the Labelling Zone will also connect manufacturers with regulatory consultants who provide market-specific expertise on evolving requirements. These specialists help companies navigate the complexities of EU FMD updates, interpret Chinese NMPA guidance, understand Indian CDSCO mandates and anticipate emerging requirements in other markets. Their insights prove invaluable in developing forward-looking labelling strategies that accommodate not only current requirements but also anticipated regulatory evolution.

Meanwhile, the pharmaceutical labelling landscape continues to evolve at great pace. Additional requirements are emerging around environmental sustainability, patient-centric information design and digital connectivity, further reshaping labelling strategies. The European Commission's proposal for revised pharmaceutical legislation [7] includes provisions for enhanced digital product information and sustainability requirements that will impact labelling approaches, with China and India making similar advances to their regulatory frameworks. So while the future of pharma labelling is unclear, one thing is for certain: you’ll see it first at CPHI Milan.