,
2 min read
In January 2006, the United States Food and Drug Administration (US FDA) introduced the Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content. When the SPL format was mandated, it not only refined the label content but also served as an opportunity for organizations to examine and streamline the processes of generating label information. Today, with increasing Regulatory digitization initiatives and the rise of structured content management, SPL continues to remain a critical component of Regulatory submissions.
Despite being such a well-defined format, for over a decade now, manufacturers often find compiling an SPL challenging. In what way? Some of the most common challenges are listed and briefly discussed below. These challenges continue today, especially as global Regulatory Authorities move toward digital labeling, ISO IDMP alignment, and data-driven submissions.
- Unreliable source of label content: Unreliable source of label content leads to incorrect labels, which, when promoted, end up misinforming the physicians and end-users. Such an implication might lead to product recalls and is unacceptable while compiling an SPL submission. Organizations must ensure that the label content is from a reliable source and verify it with expert assistance, if needed. Leveraging centralized content repositories, CCDS-based labeling, and validated Regulatory content-management systems can significantly reduce the risk of inaccurate SPL data.
- Lack of Regulatory process know-how: With an evolving Regulatory landscape, there is a possibility of alterations in guidance documents and related regulations. Without the right knowledge on such Regulatory aspects, companies may encounter a loop of rework while compiling SPL. If organizations do not track these changes and implement them on time, the submission might be subject to the FDA’s rejection. To begin with, organizations must not only keep track of global Regulatory changes but should also ensure they are fully aware of the SPL submission process. Staying aligned with current FDA updates, HL7 standards, electronic submission requirements, and Digital Health Authority recommendations is now essential to ensure SPL accuracy and compliance.
- Legacy software: Before integrating a tool for compliant SPL creation and submission, users should examine if the tool aligns with the FDA recommendations, such as 21 CFR Part 11 criteria and Health Level Seven Standards. Legacy tools may not be fully compliant and equipped to meet the process requirements, such as request tracking, format conversions (XML to PDF and MS Word), validations, version management, and many other requirements, which, if not catered to, will slow and complicate the submission process. Modern SPL publishing platforms equipped with automated XML validation, IDMP compatibility, AI-assisted quality checks, and end-to-end labeling lifecycle management are becoming the industry standard.
The challenges listed above are only from an outer perspective on the problem. Stakeholders involved should decode the complete process limitations and address them at the root-level. Enroute, they might have to depend on right Regulatory assistance and a secure and reliable software for creating, validating, storing and submitting an SPL. Be informed and compile compliant and successful SPL submissions.
In today’s environment of global Regulatory tightening, real-time label synchronization, and data standardization initiatives, partnering with SPL and labeling experts has become crucial for ensuring accuracy, compliance, and faster approvals.
