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FDA Posts Final Guidance for the Electronic Submission of Post-marketing Safety Reports

For just a few seconds, I want you to close your eyes and take a deep breath. Exhale. Now picture yourself at work in the regulatory operations and safety department of a biopharmaceutical company. It is 5:20 PM, and you and another colleague are headed out of the door for the day. You both wanted to leave a few minutes early to get a jump on the traffic to see your child’s soccer game and your colleague to head off to their own personal engagement.

Suddenly, a pharmacovigilance colleague bursts through your office door and announces, “We have an urgent post-marketing safety report submission that must go out this evening!” Since this will be a paper submission, you make the necessary copies, and your colleague readies an express envelope shipping label. It’s now 5:50 PM as the elevator dings, and the doors open at the lobby. You place the submission shipping packet in the express delivery bin along with the other articles awaiting pick up by the driver. You made it with time to spare as the delivery pick up is in 10 minutes! Even though the agency will likely receive the submission tomorrow, it is compliant because it was stamped shipped today. And it will take the agency even longer to read it, scan it in their system, and further explore/examine it.

Believe it or not, this is how post-marketing safety reports for pharmaceutical products were handled just over 20 years ago. Today, this process is very different. When your pharmacovigilance colleague has a post-marketing safety report submission confirmed, it takes two or three clicks of a mouse to send it to the agency. The transaction is fast, and the sender receives confirmation. On the receiving end, the health agencies’ database is populated, and the report is evaluated in their automated information system.  

Last week, the US Food and Drug Administration (FDA) posted final guidance which outlines the process and steps for electronically submitting post-marketing safety reports for drugs and biologics. This guidance is the result of a 2014 FDA draft guidance to simplify and clarify the safety reporting process.

The FDA posted Providing Submissions in Electronic Format—Postmarketing Safety Reports final guidance on April 27, 2022. The final guidance is intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The scope of the guidance includes New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLA), as well as certain combination products and compounded drugs. The guidance does not apply to vaccines, whole blood or blood components, combination products marketed under a device application, lot distribution reports, and certain specified cell and tissue products.

An Individual Case Safety Report (ICSR) describes an adverse drug experience of an individual patient or subject. ICSRs are time sensitive and should be filed as soon as a safety issue has been identified. A post-market ICSR, and any associated attachments, are to be submitted to the FDA Adverse Event Reporting System (FAERS) database. This new guidance explains that FDA provides two options for electronic submission of ICSRs and ICSR attachments to FAERS:

  1. direct submission through the Electronic Submissions Gateway (ESG) or
  2. submission through the Safety Reporting Portal (SRP).

Both options are available 24 hours a day, 7 days a week. Once an ICSR submission is successfully recognized and decrypted, an ESG message delivery notice (MDN) is sent to the submitter. This MDN serves as the official FDA receipt date of each successfully transmitted ICSR and ICSR attachment in the submission. Finally, you can submit ICSRs either as an individual report, or several individual reports in a batch.

What’s next? In the future, the same process will be adopted for investigational ICSRs. In the meantime, sponsors should continue to submit Investigational New Drug (IND) Safety Reports using eCTD format. The FDA will update their web page when final guidance is published and will accept IND and IND-exempt bioavailability/bioequivalence (BA/BE) safety reports via this mechanism described above.

The Federal Register also has a posting on this new guidance.

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About the author

Robert Labriola
By: Robert Labriola

Rob has over 25 years of experience in regulatory submissions. He has involvement in the production of electronic regulatory submissions to numerous health agencies, at all roles and leadership levels. Rob has been with Certara’s Synchrogenix division for 5 years where he heads up the regulatory operations team.

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