Health Canada Clarifies Policies for Notifications of Foreign Regulatory Actions
Regulatory News | 13 July 2018 |
Health Canada issued new guidance on Thursday to aid pharmaceutical companies in complying with previously set requirements on notifications of foreign regulatory actions.
The guidance operationalizes Health Canada’s interpretation of the notification requirements under provisions of the Protecting Canadians from Unsafe Drugs Act.
“These provisions are intended to improve the collection and assessment of new relevant safety information in respect to any serious risk of injury to human health involving regulatory issues in foreign countries and help determine an appropriate response in Canada to these issues,” the regulator said.
By requiring drug manufacturers and importers to issue these notifications, the Minister of Health can obtain early insights into foreign regulatory actions. This information can then be used to inform Health Canada’s assessments of serious risks to patient health and potential interventions.
In a Q&A format, the guidance answers eight questions on the notification requirements.
It also provides answers to three sub-questions regarding the kinds of foreign actions that would call for notifications. These include serious risks related to a manufacturing issue or a new contraindication made public by a foreign regulator or manufacturer.
The Minister of Health must be notified of these foreign actions within 72 hours of becoming aware of the situation. This allows the minister to “determine if similar risks exist for those drugs in Canada and which action(s) would be required to mitigate these risks,” Health Canada said.
Other answered questions relate to the kinds of information that should be included to comply with a notification, as well as the regulator’s process for monitoring and assessing compliance.
Notifying Health Canada of Foreign Actions - Guidance Document for Industry
The guidance operationalizes Health Canada’s interpretation of the notification requirements under provisions of the Protecting Canadians from Unsafe Drugs Act.
“These provisions are intended to improve the collection and assessment of new relevant safety information in respect to any serious risk of injury to human health involving regulatory issues in foreign countries and help determine an appropriate response in Canada to these issues,” the regulator said.
By requiring drug manufacturers and importers to issue these notifications, the Minister of Health can obtain early insights into foreign regulatory actions. This information can then be used to inform Health Canada’s assessments of serious risks to patient health and potential interventions.
In a Q&A format, the guidance answers eight questions on the notification requirements.
It also provides answers to three sub-questions regarding the kinds of foreign actions that would call for notifications. These include serious risks related to a manufacturing issue or a new contraindication made public by a foreign regulator or manufacturer.
The Minister of Health must be notified of these foreign actions within 72 hours of becoming aware of the situation. This allows the minister to “determine if similar risks exist for those drugs in Canada and which action(s) would be required to mitigate these risks,” Health Canada said.
Other answered questions relate to the kinds of information that should be included to comply with a notification, as well as the regulator’s process for monitoring and assessing compliance.
Notifying Health Canada of Foreign Actions - Guidance Document for Industry
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