Health Canada Notice on the Discontinuation of Acknowledgement Letters for Regulatory ActivitiesPublished on March 27, 2019
Author: Pinky Mazumder
On January 30, 2019, Health Canada published a Notice announcing a proposal to discontinue acknowledgement letters (Acknowledgement of Information Received) for regulatory activities submitted to Health Canada. Such regulatory activities under Part C, Division 1 and Division 8 of the Food and Drug Regulations include:
Market authorization submissions:
New Drug Submission (NDS)
Abbreviated New Drug Submission (ANDS)
Extraordinary Use New Drug Submission (EUNDS)
Abbreviated Extraordinary Use New Drug Submission (AEUNDS)
Application for a Drug Identification Number (DINA)
Application for a DIN - Biological (DINB)
Application for a DIN - Disinfectant (DIN-D)
Application for a DIN - Category IV (DIN-F)
Post-approval change submissions:
Supplement to a New Drug Submission (SNDS)
Supplement to an Abbreviated New Drug Submission (SANDS)
Notifiable Change (NC)
Post-authorization Division 1 Change (PDC)
Post-authorization Division 1 Change - Biologics (PDC-B)
Supplement to an Extraordinary Use New Drug Submission (EU SNDS)
Supplement to an Extraordinary Use Abbreviated New Drug Submission (EU SANDS)
Supplement to a New Drug Submission - Conditional (SNDS-C)
PBRER/PSUR and RMP
Periodic Benefit Risk Evaluation Report - Conditional (PBRER-C)
Periodic Benefit Risk Evaluation Report - Pharmacovigilance (PBRER-PV)
Periodic Safety Update Report - Conditional (PSUR-C)
Periodic Safety Update Report Pharmacovigilance (PSUR-PV)
Risk Management Plan - Pharmacovigilance (RMP-PV)
Undefined Pharmacovigilance (UD-PV)
Development Safety Update Report (DSUR)
However, this change will not affect submissions or supplements which require certification once they are administratively complete under the Patented Medicines (Notice of Compliance) Regulations.
Health Canada proposed that as of April 1, 2019, acknowledgement letters for aforementioned submissions will be discontinued in an effort to align with internal processes. Health Canada suggests sponsors refer to the Drug Submission Tracking System – Industry Access (DSTS-IA) for information on their submissions. The DSTS-IA can provide information such as the control number, submission type, submission class, date of filing (CR date), dossier ID, drug product manufacturer, active ingredient, submission status, submission date, and target date. Sponsors are encouraged to contact the Office of Submission and Intellectual Property (OSIP) to set up an account for DSTS-IA.
For more information on the Notice published by Health Canada, please see the reference section below. Thank you for reading Regulated Affairs, the CAPRA blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Please feel free to share our blog posts and join us on social media.
Notice: Discontinuation of Acknowledgement Letters for Regulatory Activities received by Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-discontinuation-acknowledgement-letters.html
Artificial Intelligence – Revolutionizing the Healthcare Industry
What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit behaviors such as...
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...