Health Canada: Discontinuation of Acknowledgement Letters for Regulatory Activities

Health Canada: Discontinuation of Acknowledgement Letters for Regulatory Activities

March 05, 2019

On 30th Jan 2019, Health Canada issued a notice that effective from 01st April 2019, it will discontinue issuing acknowledgment letters for regulatory activities submitted by the Sponsors. These regulatory activities include the following, but not limited to:

  • Development Safety Update Report (DSUR)
  • New Drug Submission (NDS)
  • Periodic Benefit Risk Evaluation Report – Conditional (PBRER-C)
  • Periodic Safety Update Report - Conditional (PSUR-C)
  • Periodic Safety Update Report Pharmacovigilance (PSUR-PV)
  • Risk Management Plan - Pharmacovigilance (RMP-PV)
  • Undefined Pharmacovigilance (UD-PV)

It also states that the information currently found on acknowledgement letters can be obtained from the Drug Submission Tracking System – Industry Access (DSTS-IA).

This system can also be accessed by the Sponsors and Marketing Authorisation Holders to view the following details of their submissions:

  • tombstone submission information, i.e. control number (“submission number”), submission type, submission class, Lead Bureau/Office, date of filing (also known as “CR date”), dossier ID
  • drug product information, i.e. product name, manufacturer, country, active ingredient
  • status history information, i.e. submission status, status date and target date
  • review history information, i.e. review details including review type, division, status of the review (i.e. pending, active, completed) and status dates
  • document history, i.e. documents issued and received, including dates

More information on this subject and the details of setting up an account for DSTS-IA can be found in Health Canada website.

Reference:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-discontinuation-acknowledgement-letters.html

QVigilance Team
QVigilance Team

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