On May 23, 2018, Health Canada published two new Adverse Reactions Guidance Documents for Marketed Health Products (including Natural Health Products or NHPs) and their reporting. Both come into effect immediately. The scope of marketed health products encompassed by both these guidance documents includes Natural Health Products (NHPs), Pharmaceutical Drugs (both prescription and non-prescription), Radiopharmaceutical Drugs, and Biologics (including vaccines and biotechnology products).
The first guidance document, titled “Reporting Adverse Reactions to Marketed Health Products” discusses the procedure of how to report Adverse Reactions (ARs) to the Marketed Health Products Directorate (MHPD). Every Market Authorization Holder (MAH) of a Marketed Health Product (MHP) covered in the scope of this guidance document must have written procedures in place for the receipt, evaluation, and reporting of ARs. This is especially important as every MAH is required to report serious ARs known to them involving their MHP in order to comply with the requirements of the Food and Drugs Act and its Regulations (FDR).
As defined in the Regulations, a serious adverse reaction is an unintended or noxious response to an MHP (at any dose) that that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Another type of AR to be vigilant for is an Unexpected Adverse Reaction. An AR is considered “Unexpected” when the ARs specific nature, health outcome, severity or frequency is either not identified or not consistent with the product labeling. ARs that occur must be reported in expedited fashion (within 15 calendar days of receiving the relevant information). If occurring outside Canada and both serious and unexpected, a Foreign AR Report is required. If occurring within Canada, either serious or unexpected, a Domestic AR Report is required.
The second adverse reactions guidance document titled “Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products” discusses the procedure of how to prepare and submit Summary Reports (both annually or issue-related) to the MHPD. Annual Summary Reports (ASRs) are required in accordance with section C.01.018 of the FDR where the MAH must conduct, on an annual basis, a critical concise analysis of all ARs to their MHP and prepare a summary report relating to the AR reports received during the last 12 months. Concerning Issue-Related Summary Reports (IRSR), Health Canada may require (at any time) that the MAH submit an IRSR about a specific safety or efficacy issue that Health Canada wants a target analysis on in accordance with section C.01.019(1) of the FDR.
For more guidance on how to evaluate and classify ARs and assistance with preparing case reports, annual summary reports, and customer complaint templates, please contact dicentra for more information.
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