By the end of 2027, the global GS1 Sunrise initiative aims to transition the pharmaceutical sector from traditional 1D barcodes to 2D barcodes, such as a QR code. The goal is to improve traceability, tracking, serialization, and authentication across the supply chain. While completely voluntary, GS1, a non-profit, global data standards organization, states the importance of aligning efforts for all supply chain stakeholders, from clinicians to patients.
“As with previous industry transformations, adoption is expected to progress gradually, with momentum building as more organizations implement and realize the benefits,” says Ullrich Mayeski, customer success director, Healthcare, GS1 US. “As Sunrise 2027 progresses, healthcare environments will increasingly align with broader retail capabilities, helping to extend end-to-end visibility from manufacturers through to the point of use. More broadly, the shift to 2D introduces additional opportunities for the pharmaceutical sector, including enhanced access to product information, patient engagement, and more efficient data sharing across the supply chain.”
As labels evolve from static to digital, industry faces the dual challenges of global compliance and patient-centricity. Digital labels can enable real-time updates, patient accessibility, and global label harmonization. According to Freyr Solutions spokesperson, digital labels use standardized, XML-based formats, such as Structured Product Labeling, to ensure that content is machine-readable and easily updatable. These labels can include hyperlinks, embedded videos, dosage calculators, and real-time updates directly from regulatory databases. This facilitates faster regulatory submissions, enhances global consistency, and reduces compliance risks.
Stakeholder Connectivity
Currently, digital label adoption differs by region. Countries like Japan, Singapore, Saudi Arabia, UAE, Qatar, and Bahrain have all taken steps to mandate digital labeling in healthcare. Japan went even further and basically eliminated all paper inserts for medical devices and medicines. On the other hand, the U.S., EU and Canada are using a hybrid system of digital and paper labels.
“The broader adoption of electronic labeling depends on convergence around internationally recognized technical standards and continued collaboration between regulators and industry,” says Sergio Cavalheiro Filho, manager, Regulatory Affairs, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Representing public health stakeholders, IFPMA contends that medical product information is designed with the intent to ensure prescription and non-prescription healthcare products safely and effectively. This information plays a pivotal role in ensuring patients understand their treatments while supporting healthcare providers in decision making.
Cavalheiro adds, “Electronic labeling offers an opportunity to provide patients with up‑to‑date, regulator‑approved, and multilingual information in ways that support patient safety, inclusivity, and better adherence to treatment.”
A 2026 PMMI report found that pharmaceutical packaging continues to evolve as technology-focused features gain traction, enhancing customer experiences and connecting manufacturers, care providers, and patients through a network of digital data. In fact, 67% of respondents say they use QR codes and other scannable features in their pharma packaging. QR codes allow manufacturers to better track product movement both internally and in the supply chain, ensuring quality and authenticity. Distributors can also scan the codes to double-check origin, destination, product type, and authenticity. On the consumer side, customers can scan codes to verify their products, receive instructions for dosage and compliance, and connect with the manufacturer directly.
The report states, “This connectivity holds promise for all stakeholders: monitoring patient compliance and clinical trial tracking, tracing products in the supply chain, and curating better customer experiences through interactive features and direct connection with the brand. Digital connectivity in pharmaceutical packaging is the next frontier of efficiency.”
DDLs in the Clinical Supply Chain
In the clinical environment, paper labels have been an industry bottleneck due to their static content and lengthy production times. Additionally, global focus on patient safety and accessible information is increasing, as is the need to address drug shortages and promote diversity, equity, and inclusion in the healthcare industry. This has all resulted in a growing demand for a digital clinical supply chain. Digital Display Labels (DDLs) address these needs by allowing real-time updates and multilingual capabilities, reducing waste and improving patient compliance.
“Reducing reliance on printed materials means that the most current safety information can quickly be made available, and enables formats such as instructional videos that cannot be replicated on paper,” says Cavalheiro. “It also lowers the environmental footprint associated with printing and packaging, and provides greater flexibility in global supply chain management to help mitigate medicine shortages.”
Merck and Janssen Pharmaceutica NV, a Johnson & Johnson company, have been collaborating to modernize the pharmaceutical sector using DDLs (previously seen in Healthcare Packaging). They envision DDLs replacing traditional paper labels on investigational medicinal products (IMPs) used in clinical trials to enable easy and on-demand updates of label content for clinical study personnel, caregivers, and patients. Consider that any changes in study design or protocols could have significant implications on the labeling and distribution of clinical supplies. Using a DDL, modifications, such as updating the IMPs expiry date, can be made without manual relabeling. This reduces the risk of label inconsistencies, errors, and administrative burden.
Representatives from Merck and Janssen are members of the Digital Display Label Community of Practice, part of the Clinical Supply Leadership Forum, a group dedicated to harmonizing industry application of DDLs. In a position paper, the group acknowledges challenges with adopting DDL use in a highly regulated industry and the required investment in hardware and software. However, they say the benefits far outweigh barriers to adoption, “With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the potential to revolutionize drug development and to increase and expedite patient access to therapies. The transformative capabilities of DDLs pave the way for more efficient and patient-centered clinical trials.”
Whether in the clinical environment or throughout the supply chain, technology-oriented packaging features like digital labels will play a key role in protecting manufacturers, products, and consumers in the pharmaceutical supply chain.
