Periodic Adverse Drug Experience Report (PADER) in a nutshell

Periodic Adverse Drug Experience Report (PADER), as the name depicts, is an aggregate safety report that summarizes the adverse events and reactions for the approved medicinal product within a definite period (reporting interval). It is required to be submitted by a sponsor or MAH to the USFDA once authorization of the medicinal product is approved in the US. It summarizes changing post-approval adverse event profiles, safety information of an approved drug, and the benefit-risk profile evaluation.

For the initial three years, the company must submit the report quarterly within 30 days of the quarter’s close and annually within 60 days of the US approval date.

This safety report is intended to update and evaluate the global safety experience and risk-benefit profile of the medicine after approval. These evaluations help to ascertain information about changes required in the product labelling (if any) or any additional investigation to be carried out further. In addition, it acts as an interface to report new relevant safety information and create opportunities for periodic re-evaluation of safety.

Components of the Periodic Adverse Drug Experience Report (PADER)

• It is a single pdf file with a table of contents, bookmarks, and hyperlinks.
• According to eCTD ICH format, the PDF file should be uploaded on the node m5.3.6, in the eCTD tree hierarchy within Module – 5 Clinical Study.
• PADER consists of concise narratives for 15-day alerts (initial and follow-up reports). Only serious and unlisted cases, identified from domestic and foreign sources (supposedly reported to the USFDA), are considered under 15-day alert reports during the reporting interval. All the remaining cases (serious listed, non-serious unlisted, and non-serious listed domestic cases) are considered under non-15-day alerts during the reporting interval. It also comprises the summary tabulation for all the adverse events (preferred terms as per the latest Medical Dictionary for Regulatory Activities; MedDRA) by System Organ Class based on seriousness and labelling for all the cases to be submitted to the USFDA for the ANDA/NDA number. A separate section presents individual case narratives for cases with fatal outcomes and/or events of particular interest (e.g., overdose, lack of efficacy and non-most suspect drug).
• Another section represents the current product package labelling, changes made in labelling during the reporting interval (if any), studies undertaken (if any), summary of foreign actions (if any) and new safety information (if any).
• If numerous cases are included, they can be represented in a tabular format. However, suppose no issues are reported for a medicinal product during the reporting interval. A null report and relevant appendices (listing [showing no reported cases] and US Package Insert) are prepared in that case. Irrespective of the number of cases, the final submission includes a cover letter, field copy certification, PADER copy, line listings, package insert, and form FDA 356 h (application to market a new or abbreviated new drug or biologic for human use). Post June 10th, 2015, PADER is accepted in electronic format.