Issues related to the quality and accuracy of ASRs remain the second most common regulatory observation seen in 2021-22, second only to Serious Adverse Drug Reactions Reporting1. ASRs accounted for 20% of the observations during this period. Post Health Canada GVP inspection observation related to management and/or preparation of ASRs constitute one of the most frequently reported observation on the Health Canada inspection database2.
With the scrutiny on ASRs on the rise, how can MAHs avoid the common ASR audit observations?
Guidance contained in C.01.018 lays out the requirements for Canadian MAHs to prepare and submit summary reports for marketed drugs and natural health products on an annual basis according to Health Canada guidelines3.
Annual summary reports (ASRs) are expected to provide an overview of the benefit-risk profile of marketed drugs or natural health products distributed globally and in Canada within an established interval post-marketing.
In order to do so, MAHs need to review all safety data available to them in the post-market context including pharmacovigilance activities and patient exposure in Canada and globally. This includes review of aspects related to risk minimization strategy and evaluation of its effectiveness.
One of the most common issues with the ASRs is the absence of a detailed critical analysis, concise evaluation and a discussion of the safety data that was gathered during the 12-month period. Health Canada expects this to be basis for MAHs to make the appropriate and timely decisions to update the product safety information, should there be serious issues identified during the process.
Failure to meet this primary objective of ASRs and compliance to the Health Canada guidelines in preparing and submitting summary reports for marketed drugs and natural health products may result in audit observation.
Zenith PV Solutions has experience working with Health Canada auditors and authoring ASRs that avoid the common observations. We will be pleased to support ASR related requirements either to help address observations or prepare you for your next audit. Contact a Zenith partner today at email@example.com
- DIA 2022 Ottawa. Data presented by Myriam Salem- Senior Corporate Regulatory and Enforcement Advisory at Health Canada
- The drug and health products inspections database (DHPID) – Canada.ca
- The Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry – Canada.ca