Understanding Regulatory Adverse Event Reporting Requirements – US-FDA Post marketing

Post Marketing Safety Reports:

The manufacturers must submit post-marketed safety reports to the FDA in electronic format for their medicinal products and vaccines.

Types of Adverse event experiences:

• Serious and unexpected adverse experiences from all sources, whether domestic or foreign, must be submitted to the FDA. Possible sources include, for example, scientific literature, postmarketing studies, or commercial marketing experience. 
• Adverse experiences occurring in the United States from commercial marketing experience must be submitted to the FDA if they are spontaneously reported and are:
  • serious and expected
  • non-serious and unexpected, or
  • non-serious and expected 

Types of Reports:

Postmarketing 15-day “Alert reports”. The adverse drug experience that is both serious and unexpected, whether foreign or domestic, must be reported as soon as possible but no later than 15 calendar days from initial receipt of the information by the applicant.

Postmarketing 15-day “Alert reports” – followup. The manufacturer must promptly investigate all adverse drug experiences that are the subject of these postmarketing 15-day Alert reports and must submit followup reports within 15 calendar days of receipt of new information or as requested by FDA. If additional information is not obtainable, records should be maintained of the unsuccessful steps taken to seek additional information.

Postmarketing Periodic Reports – Postmarketing periodic reports are required to be submitted to the FDA for each approved NDA, ANDA, and BLA and are due quarterly for the first 3 years after U.S. approval of the application and annually thereafter. Periodic reports due quarterly must be submitted within 30 calendar days of the last day of the reporting quarter. Reports due annually must be submitted each year within 60 calendar days of the anniversary date of U.S. approval of the application for the drug or biological product (i.e., NDA, ANDA, BLA).

References:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-safety-reporting-human-drug-and-biological-products-including-vaccines

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.80