Pharmacovigilance: Canadian requirements
By Innomar Strategies
Patient safety is a fundamental principle followed by all health authorities. But Health Canada does have some specific requirements surrounding pharmacovigilance. Devendrakumar Patel, Director, Pharmacovigilance & Medical Information shares some of these mandates, including the need to promptly report serious drug adverse reactions and foreign safety actions. He also emphasizes the advantage that local expertise offers you.
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Transcript of 'Pharmacovigilance: Canadian requirements'
What are the unique pharmacovigilance requirements in Canada?
When talking about the uniqueness of Health Canada's pharmacovigilance requirements, it is also important to consider that patient safety is the fundamental principle followed by all the health authorities.
However, Health Canada has some specific requirements regarding the pharmacovigilance obligation for marketing authorization holders and importers. In Canada, marketing authorization holders and importers both are subject to pharmacovigilance inspection, and the reason behind this is that their names appear on the product label and that is the reason they might receive the adverse drug reactions.
In Health Canada, there is a unique requirement to have qualified healthcare professionals also on the pharmacovigilance teams. There is also a requirement about the reporting of the adverse drug reactions, and Health Canada expects that all the local serious adverse drug reaction reports as well as unusual failure of efficacy reports associated with the new drug supposed to be reported within 15 days to the Health Canada.
There is also a requirement to report the foreign safety actions associated with the drug, and the reporting requirement has a very tight timeline, which is 72 hours. Health Canada expects that MAHs should report any safety action associated with the drug marketed in Canada taken by the foreign regulatory authority supposed to be submitted within 72 hours.
Now we talk about all the reporting obligations, so we always need to consider the documentation associated with that. Apart from this, there is also one unique requirement about the medical information call center. That medical call center service is supposed to be available in both French and English languages.
Considering the uniqueness of the pharmacovigilance requirement, as well as the medical information requirement, local expertise can help to meet this specific obligation associated with the pharmacovigilance in Canada.
