Health Canada eCTD Update

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Last month, Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format.  As with other agencies and regions, this helps move Health Canada towards a common submission intake process, as well as standardize and improve its business processes and tools. Previously, as of January 2018, New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS), and Supplement to an Abbreviated New Drug Submission (SANDS) were required to be submitted in eCTD format.

This recent announcement communicates Health Canada’s intention to expand the scope of regulatory activity types where filing in eCTD is a mandatory requirement, which encompasses the remainder of all other types of human drug submissions.

Additionally, Post-market Vigilance Data (Human Drugs only) is targeted to take effect this coming June, 2019.  This will include:

  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit Risk Evaluation Report (PBRER), when provided to the Marketed Health Products Directorate (MHPD)
  • Risk Management Plan (RMP), when provided to MHPD
  • and other Post-market Vigilance data requested by MHPD

The Health Canada eCTD notice (February 5, 2019) for the mandatory use of eCTD format can be found here.

Synchrogenix has over ten years of experience converting clients from paper to electronic format, and ensures efficient, timely submissions through software and services solutions that break down barriers between strategy, dossier development and global transmissions. Click here to learn more about Synchrogenix’s Regulatory Operations eCTD Software and services. 

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Author: Rob Labriola

Rob Labriola has 20 plus years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understands the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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