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3 min read
The dynamic environment of pharma regulatory requirements for packaging artwork presents significant challenges for pharmaceutical and life sciences companies in meeting the latest mandates. Following the rapid updates in artwork regulations, companies are facing one of the most critical phases in their lifecycles. On the one hand, the existing product chain is running out of patent timelines, leading to significant financial challenges; on the other hand, traditional products are struggling to meet regulatory compliance gaps due to regulatory changes. Moreover, the growing global markets are giving rise to the expansion of new markets worldwide, posing a threat to traditional passive markets.
With increasing scrutiny from global health authorities such as the FDA, EMA, MHRA, TGA, and Health Canada, the need for accurate, compliant, and audit-ready regulatory artwork has become even more critical in 2024–2025. Companies are now prioritizing digital artwork management, automation, and centralized artwork operations to mitigate compliance risks.
To address the situation initiated by dynamic artwork regulatory challenges, companies are producing more variations and alternatives of their current products and launching them in emerging markets. Implementing this practice leads to changes in the physical packaging of the products as the components change, thereby making the artwork creation and maintenance an intricate process to achieve.
Additionally, the rise of e-labeling, sustainability-driven packaging redesigns, and serialization requirements has further increased the complexity of artwork management, making structured artwork governance a critical need.
For companies with an extensive product line distributed globally across various regions, a perfect balance between business process and product information management is required to maintain artwork compliance. However, regardless to the size of the organization, companies witness similar errors/defects throughout the artwork creation, a few of which are discussed below:
Content Defects
This is a direct error that is observed in the detailed artwork information about the product. Errors, such as omissions or incorrect symbols, in the information generally fall into this category.
These issues are now more visible as companies shift to multi-market packaging and shared content repositories, increasing the risk of inconsistent data across SKUs.
Gross Defects
This is a major error that arises because a crucial piece of information is missing completely from the detailed product information. Such information can be a recent regulatory update that entails changes in the artwork.
With frequent guideline updates—such as the inclusion of QR codes, font-size requirements, changes to safety icons, or updates to risk-mitigation labels—missing content can directly trigger observations from Health Authorities.
Technical Defects
The technical aspects of packaging of such as a barcode on the pack, may lead to these errors because of incorrect specifications or information about the product mentioned in the barcode.
Today, inaccuracies in GS1 barcodes, 2D matrix codes, die-line issues, color profile mismatches, and print-ready artwork errors continue to be among the top causes of packaging rejection at manufacturing sites.
Context Defects
This error implies that the information on the artwork is presented in an unclear or incorrect manner, which may mislead the viewer's understanding of the information. Such errors may occur due to the improper use of symbols or special characters.
Contextual errors commonly arise during translation workflows and multi-language label creation, especially in global markets with strict linguistic accuracy requirements.
These errors in packaging artwork can have severe implications for companies, including revenue loss due to product recalls if they fail to meet regulatory compliance, or even put their reputation at risk in the global market. Regulatory experts worldwide recognize these risks and are committed to driving advanced operations that result in superior packaging artwork creation, in line with the regulatory environment.
Recent industry studies indicate that 60–70% of product recalls originate from labeling and artwork issues, making artwork accuracy a crucial pillar of brand integrity and regulatory compliance in 2025.
It has been observed that a lack of good communication and competence are among the major reasons for these errors to appear. Therefore, companies need to rely on trained specialists who are well-versed in the latest regulatory updates and proficient in managing the pharmaceutical artwork creation lifecycle.
As companies embrace centralization, artwork automation tools, AI-driven proofreading, and artwork managed services, the demand for specialized regulatory artwork partners continues to grow. These experts help organizations minimize errors, standardize artwork processes, accelerate time-to-market, and maintain compliance across global markets.
