Missing documents and broken links are just a few of the things that can make your eCTD submission non-reviewable. To ensure submission success, you must review every detail of your dossier before you deliver it to the Health Authority. And that means every detail, from confirming its technical accuracy to verifying that the contents are exactly where they need to be, to ensuring that each link works without fail.
While our REVIEW product guides you through this process, it’s important to know Best Practices for getting it right. Here are some things you should know:
1. REVIEW & CLARIFY CURRENT GUIDANCE
Regulations are not static entities; they change over time. Before your first submission is reviewed, you should have a clear understanding of current procedures and develop a practical approach for your organization to support this guidance. In addition to reviewing established guidance, review available agency presentations, as the reviewers for each agency often discuss informal best practices and suggestions for creating easily reviewable submissions.
2. CREATE A REVIEW CHECKLIST
Your review process should be thorough, succinct and repeatable. Create a checklist outlining your review criteria and assign responsibilities. After you’ve completed your checklist, it’s a good idea to file it.
3. DEFINE YOUR HYPERLINKING PRACTICES
A major challenge of electronic submissions is incorrect hyperlinking. As regular file maintenance occurs over time, some of the files may be deleted or replaced, resulting in broken hyperlinks that point to out-of-date files. When reviewing your dossiers, always check that all linking is active and working properly.
4. CREATE PDFs FROM ELECTRONIC SOURCES
In most cases, regulatory authorities would prefer not to receive scanned documents. Rather than scanned input, PDFs should be generated from the electronic native documents wherever possible. The ability to search in and copy text from these documents is critical to agency reviewers. If you still obtain handwritten signatures for your documents, consider practices that will allow these signatures to be included in source documents without scanning.
5. ALWAYS USE A FILLABLE 356h (OR OTHER APPLICATION) FORM
The FDA has a strong preference for fillable forms. Although the agency has not mandated the use of these forms, they have noted that the advantage of using the gateway for submission diminishes considerably if fillable forms are not used.
7. ESTABLISH HEALTHY COMMUNICATION WITH THE HEALTH AUTHORITY EARLY
Establishing clear communication with the health authority is an important step in delivering "reviewable" submissions. In the U.S., communication begins with the FDA Office of Business Informatics (OBI) – Division of Regulatory Review Support, who will provide assistance to industry in support of the submission review process.
6. DON'T GO IT ALONE - USE PROFESSIONAL REVIEW TOOLS AND SERVICES
All review software is not created equal. For proper eCTD review, you need the proper tools. That’s why it’s a best practice to use a proven eCTD review application such as GlobalSubmit’s REVIEW. REVIEW is the only review solution used by FDA regulators.
One feature that separates REVIEW from other reviewing applications is the ability to see "reviewable units" as opposed to just a summary of current or removed documents. The relationship between the submissions in a single eCTD dossier determines the reviewable unit that regulatory reviewers take action on when they process eCTD submissions. In addition, REVIEW makes it easy for you to reorganize and customize the view of your submission files according to their preferences and business rules, thus eliminating incorrect relationships between sequences.
Because REVIEW separates the concepts of data transfer and data presentation, the integrity of the submission files and the eCTD backbone is not compromised during the review process.
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