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.
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