FDA delays PMSR requirements for combination products

The US Food and Drug Administration (FDA) have delayed the enforcement of post-market safety reporting (PMSR) requirements for combination product manufacturers, which gives affected registrants more time to ensure compliance.

A guidance document has been published to help combination product applicants who are subject to the combination product post-marketing safety reporting final rule that was issued on 20th December 2016. The FDA have delayed the PMSR requirements to ensure that combination product applicants have sufficient time to update reporting and record keeping systems and procedures, including information technology systems, to comply with the requirements. The delay also helps to ensure that applicants have sufficient time to consider the recommendations and technical specifications that the FDA intends to provide through guidance to support compliance.

The FDA has set two new PMSR enforcement dates relating to which system combination product applicants use to submit individual case safety reports (ICSRs):

  • 31st July 2019 for combination product applicants reporting ICSRs through the FDA Adverse Event Reporting System (FAERS) and the Electronic Medical Device Reporting System (eMDR).
  • 31st January 2020 for combination product applicants using the Vaccine Adverse Event Reporting System (VAERS) for ICSR submissions.

To view additional FDA draft guidance, which aims to fully explain PMSR compliance requirements, please click here.