The Electronic Common Technical Document (eCTD) has become the global standard for submitting regulatory information to agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). While the eCTD was designed to streamline the submission process and improve regulatory review efficiency, its complexity can present significant challenges for many organizations.
From navigating the structure to dealing with regional variations, eCTD compliance can quickly become overwhelming, especially for smaller companies or those new to the process. This blog will explore some of the most common pain points related to eCTD compliance and provide practical solutions to help companies overcome these challenges.
Understanding the eCTD Structure: The Foundation of Compliance
One of the primary hurdles that companies face is understanding the eCTD’s rigid and detailed structure. The eCTD is divided into five modules, each with specific content requirements. It’s important to ensure all information is in the correct module. For example, while Module 1 contains regional-specific information, Modules 2 through 5 follow a standardized format across regions, covering clinical and non-clinical study reports and summaries. Misplacing content or failing to follow the eCTD’s specific granularity rules can lead to delays or rejections.
To address this challenge, R&D teams should familiarize themselves with the eCTD format before beginning a submission. Utilizing internal or external regulatory experts to review the submission and ensure that content is accurately categorized can prevent costly mistakes. Additionally, leveraging content management tools designed to track and organize documents can help keep submissions compliant and streamlined.
Navigating Regional Variations: One Size Does Not Fit All
Although the eCTD was created to harmonize regulatory submissions across multiple regions, significant differences still exist. For example, Module 1—the administrative and regional section—varies depending on the submission destination. The FDA, EMA, and Japan’s PMDA have unique requirements, meaning companies submitting to multiple agencies must tailor their applications accordingly.
Successfully managing these regional variations requires careful planning. If a company is producing and managing the submission in-house, it’s necessary to stay updated on each agency’s evolving requirements and guidelines, ensuring their submissions meet the latest standards. Leveraging specialized submission publishing and management tools or outsourcing submissions to regulatory consultants with global experience can also reduce the burden of managing these regional differences.
Converting Legacy Data
For companies converting large volumes of legacy data presents yet another challenge. Many organizations find themselves overwhelmed by the task of digitizing documents and ensuring that legacy data complies with eCTD formatting requirements.
To deal with legacy information, companies typically begin by identifying the source, location, and format of all required documents and data. Once this table of contents is established, authoring, reviewing, editing, formatting, or conversion activities can be tracked against the submission deadline. Data must follow CDISC data standards as outlined in the agency’s Technical Conformance Guide and Submission Standards and Specifications. Outsourcing the conversion and digitization processes to vendors specializing in regulatory submissions can expedite the transition and ensure compliance. Additionally, implementing a robust document management system capable of supporting eCTD submission formats can streamline the process and reduce errors.
Managing Lifecycle Submissions: Keeping Track of Amendments
Lifecycle management is another complex area of eCTD compliance. Companies must track their submissions through multiple stages of review, including amendments, supplements, and other lifecycle events. Maintaining consistency and accuracy across all these submissions can be a daunting task, especially when it comes to version control.
Effective lifecycle management requires companies to adopt version control best practices and ensure that updates are properly tracked and documented. Tools that offer robust version management and tracking can be essential in this regard, helping organizations avoid duplicate submissions or inconsistencies. There are several eCTD publishing tools on the market that automate lifecycle management and the review of regulatory submissions before and after they are submitted to the agency. Having a structured process in place for reviewing and approving updates to submissions before they are sent to regulatory agencies will help improve the quality of the submission.
Avoiding Technical Rejections: The Importance of Validation
Technical validation failures are among the most frustrating challenges in eCTD submissions. The FDA has outlined varying levels of severity within its validation criteria, with high-level issues often involving data requirements, such as which studies must include data, specific formatting guidelines, and more. The FDA’s validation process is rigorous, and even minor errors—such as broken hyperlinks, corrupted PDFs, or incorrect XML coding—can lead to a technical rejection. These setbacks can result in costly delays, forcing companies to address the technical issues and resubmit their applications.
Companies should perform thorough pre-submission validation checks using the FDA’s technical specifications to prevent these setbacks. Investing in validation software that mimics the agency’s validation process can help catch errors before they reach the FDA. Additionally, employing a team with the technical expertise to manage and troubleshoot these issues is critical for companies routinely submitting eCTDs.
Staying Compliant Amid Evolving Regulatory Requirements
Regulatory requirements for eCTD submissions constantly evolve, and staying compliant can feel like a moving target. Agencies like the FDA frequently release new guidance documents and updates to submission requirements, which can impact ongoing and future submissions. Failing to stay current with these changes can result in non-compliance, submission delays, or even outright rejections.
To avoid these issues, companies should subscribe to regulatory updates from agencies like the FDA and EMA and participate in industry groups to discuss best practices and regulatory changes. By staying informed and adapting to new requirements quickly, companies can avoid unnecessary delays in their submission processes.
Simplifying eCTD Compliance for Success
While eCTD compliance is undoubtedly complex, the challenges can be managed with the right strategies and tools in place. Companies can reduce the risks associated with electronic submissions by understanding the eCTD structure, managing regional variations, effectively handling legacy data, and staying current with evolving regulatory requirements.
With careful planning and the right expertise, the eCTD process can become a streamlined part of a company’s regulatory strategy. For some companies, engaging a Regulatory Submission Management Partner may be the key to avoiding common pitfalls and ensuring timely submissions. Over 150 sponsors in 12 countries have chosen WAYS as their trusted Regulatory Submission Management Partner because we apply our expertise in innovative ways. Contact us to learn how we can help your team produce, submit, and manage compliant submissions more efficiently.
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