Providing Submissions in Electronic Format – Postmarketing Safety Reports

On June 10, 2014 the FDA published a final rule entitled Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements. At the same time, the FDA published a draft guidance to assist sponsors who have not yet converted from paper or CDs to electronic all the way. A proposed rule in this regard was published August 21, 2009.

One of the major benefits to converting to electronically submitted reports is that they will be available for analysis as soon as they have been processed by the FDA, in many instances allowing reviewers access in a mere matter of days.

This is an important ruling, and the critical thing to note is that after June 10, 2015, it will be necessary to get a waiver to submit paper or CDs. Examples of acceptable reasons for waivers include acts of nature, widespread internet outages, and temporary issues with an applicant’s adverse event database(s). FDA anticipates “that temporary waivers will be needed only in rare circumstances.” This means that those who are still submitting Adverse Events on paper have one year to convert to electronic submission. Don’t wait until the last minute.

This rule applies to: Drug products marketed for human use with approved new drug applications and abbreviated new drug applications; Prescription drug products marketed for human use without an approved NDA or ANDA, Biological products, other than vaccines, marketed for human use with approved biologic license applications, and Nonprescription (over-the-counter or OTC) human drug products marketed without an approved application. It does not apply to: vaccines; whole blood or components of whole blood; lot distribution reports; and human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service Act.

The draft guidance mentions two ways to submit electronically, direct submission through the Electronic Submission Gateway (ESG) and submission through the Safety Reporting Portal (SRP). Each method has its own web pages and staff to help. Electronic receipts will be e-mailed to the submitter in both systems. The guidance also discusses when and how to submit labeling and what to do if one or both systems are down for an extended period of time.

Reports of adverse events that do not qualify for 15-day status can now be filed at any time, rather than having to wait for the due date of the next periodic safety report. This will make filing the periodic reports easier.

It is anticipated that these new requirements will help the FDA in the timely processing and filing of postmarketing safety reports, and aid in making the postmarketing reports more readily available for analysis. Additionally, this should save the FDA an estimated $0.8 million annually, primarily in the cost of processing paper. This finalized rule regarding submitting safety information electronically is also an important initiative in aligning the FDA’s postmarketing safety reporting regulations with those of international standards. This should allow manufacturers and other parties to utilize common data elements and standards, thus enhancing the industry’s global pharmacovigilance practices.

For more questions regarding the rule, please refer to the draft guidance.