The Regulatory industry is witnessing huge transformations. Some new regulations see the light of the day as we grow in the world of automation for regulatory compliance. Intervention of information technology for submission of periodic reports in pharmacovigilance is yet another required transformation.
History of PADER/PAER submission:
The Periodic adverse drug experience reports (PADER/PAER) submission was earlier performed on paper and alternatively, electronic submission was a convenient option i.e., earlier, it was voluntary to utilize the electronic submission method for submitting this periodic report. However, the recent mandate has discontinued the paper format and submissions are now allowed only via eCTD.
US FDA Regulations:
FDA accepts PADER/PAER Submission in eCTD Format from June 10, 2015 onwards.
FDA receives information regarding post-marketing adverse drug experiences from safety reports submitted to the Agency. For nearly 35 years, FDA has received these post-marketing safety reports on paper.
As per 21CFR 314.80, each adverse drug experience report (except the post-marketing 15 day ‘Alert reports’) should be reported under periodic safety reports at quarterly intervals, for three years from the date of approval of the application, and then annually.
PADER/PAER report specifications:
- PADER/PAER is a single pdf file with proper bookmarks, Table of Contents and hyperlinking
- PADER/PAER PDF file is uploaded on the node m5.3.6 (report-of-post-marketing-experience), in the eCTD tree hierarchy within Module – 5 Clinical Study, according to eCTD ICH format
- To submit PADER/PAER descriptive portion in eCTD format, providing a Study Tagging File (STF) is not necessary.
- “Other” is used for submission type in the US-regional.xml file
- A cover letter in m1.2 section, referencing the information and also providing a hyperlink from the cover letter to where the document resides in m5.3.6, would be helpful to reviewers.
- The leaf title of the PADER/PAER includes the reporting period. The leaf title follows a standard format for future submissions.
The Periodic ADE Report in module 5.3.6 should not contain the 3500A forms, but instead, at the end of the summary, it should specify how they were submitted.
The date of submission, address shipped to and any other pertinent information for the 3500A forms in paper is to be provided.
Thus, the bottom line is FDA requires industry to submit post-marketing safety reports in an electronic format- applies to virtually all post-marketing safety reports for human drug and biologic products, which not only includes Individual case safety reports (ICSRs) but also periodic safety reports.
KnowledgeNET (www.Knowledgenet.in) is a complete eCTD solution for online submissions of dossier. Now, that PADER/PAER reports are required to be submitted through this platform, we have a provision of pharmacovigilance periodic reports submission through eCTD.
- Both the PDF and STF (Study Tagging Files) formats are supported in eCTD software.
- Our esteemed Clients have already been oriented towards using eCTD as an established platform to comply with this regulatory mandate well ahead of the stipulated timeline.