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Recent Requirement to File Post-Marketing Periodic Safety Reports in eCTD Format

January 14, 2016 | Kathy Elks, RAC, Director, Regulatory Operations | Regulatory Operations

Did you know that there are some areas within our industry where electronic common technical document (eCTD) format is already mandatory? If not, read on.

In a previous blog, I discussed FDA guidance from May 2015 which set the “wheels in motion” for mandatory eCTD submissions. Starting in May 2017, all marketing applications to the FDA (ie, NDAs, ANDAs, BLAs, and DMFs) must be submitted in eCTD format. All INDs and IND amendments must be in eCTD format beginning in May of 2018. Waivers and exemptions to this requirement were discussed in the previous blog.

As of September 2015, some documents are already required in eCTD format. Let me explain.

Post-Marketing Safety Data

FDA issued a regulation in June 2014, which required all post-marketing safety data to be submitted in electronic format, with one part submitted specifically in eCTD format, effective June 2015. The implementation date was later extended to September 2015. A draft guidance explains the specifics.

As the name implies, this requirement impacts only manufacturers, packers, distributors, and sponsors of marketed products. If you are a Regulatory professional managing INDs only, you will not be impacted by this requirement but may find this information useful for later reference.

Types of Safety Reports

There are two types of post-marketing safety reports:

  • Individual case safety reports (described below left) that are submitted on an ongoing basis, and
  • Descriptive information (described below right and also referred to as “narrative information” or a “Periodic Safety Report”), which is submitted on a periodic basis.

Both types of safety reports must be filed electronically; however, the descriptive portion must now be filed in eCTD format.


Different Formats of Post-Marketing Periodic Safety Reports

The figure below summarizes the different report formats (ie, PADER, PAER, PSUR, and PBRER) that can be used to prepare the Post-Marketing Periodic Safety Reports as well as a timeline of the regulations and guidances that led to these requirements.


References: May 1997 ICH E2C, Feb 2004 ICH E2C (R1), Dec 2012 ICH E2C (R2), Apr 2013 Draft Guidance, June 2014 Draft Guidance

thumbs If you were previously granted a waiver from the electronic submission requirement and are now looking for someone to publish your Post-Marketing Periodic Safety Reports in eCTD format, we will be happy to help! We also partner with PV companies that are looking for an eCTD publisher. Either way, IMPACT can answer your questions about the new requirement for post-marketing safety reports. Give us a call today!!!


Category: Regulatory Operations
Keywords: Post-Marketing Periodic Safety Reports, PADER, PAER, PSUR, PBRER, eCTD, publishing

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