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Health Canada/Santé Canada

Health Canada is the federal department in the Canadian government responsible for health matters, including pharmacovigilance. Their remit includes foods, drugs, devices, and many other areas well summarized in an extensive index on their website (Web Resource 25-1), which is fully available in both English and French.

The section “Drugs & Health Products” is also extensive. Canadian Product Monographs are available on the Drug Product Database. The areas that touch on drug safety include “Advisories, Warnings & Recalls,” “Compliance & Enforcement,” “Drug Products,” and “MedEffect Canada” (adverse reactions).

The drug products section includes information on drugs marketed in Canada. Some Summary Basis of Decision (which contain some safety information) documents are available.

The major section on drug safety is the “MedEffect Canada” section (Web Resource 25-2). This section contains information on the voluntary reporting of adverse reactions by consumers and healthcare professionals and the mandatory submission by Marketing Authorization (MA) holders (manufacturers and distributors). Reports from consumers and healthcare professionals may be submitted directly online by filling out a report on the website or by downloading and mailing or faxing the form to a Canada Vigilance Regional Office (there are seven such offices as well as the national center in Ottawa). MA holders must mail or fax reports to the Canada Vigilance National Office in Ottawa.

There is a Q&A section on adverse reactions describing how drug safety is done in Canada (Web Resource 25-3). As in other countries, the foundation for pharmacovigilance is the collection of adverse drug reactions (ADRs) from consumers and healthcare professionals by the seven regional and national adverse reaction centers. Each center performs an initial quality review for transmission and analysis at the national center.

Reporting requirements are summarized in a guidance for Industry on AR reporting (Web Resource 25-4). Expedited reporting for serious ADRs is obligatory for MAHs in Canada. All serious ADRs from Canada and all serious, unexpected ADRs from outside of Canada must be reported within 15 days. A formal annual review of ADRs and serious ADRs must be done and submitted within 30 days of request from Health Canada. Periodic Safety Update Reports (PSURs) are not obligatory but may become so soon. Further detail is available in this guidance.

Signals are identified by a systematic review of the reports and any other information available to Health Canada. The database (see below) is relatively small, and Health Canada is working on initiatives to partner with external agencies with larger databases (e.g., the U.S. Food and Drug Administration).

Inspections are handled by the Health Products and Food Branch Inspectorate, whose goal and function is outlined in a document available on the website (Web Resource 25-5). Inspections are done of manufacturers of pharmaceuticals and biologics and cover Good Manufacturing Practice (GMP) or pharmacovigilance activities. Two ratings are issued following an inspection: (1) C—No objectionable conditions or practices or (2) NC—Objectionable conditions or practices found. A report will be issued with observations. The inspected establishment is expected to correct the deficiencies. When necessary, enforcement actions will be made by Health Canada. From September 2005 to March 2008, 309 inspections were performed in Canada.

Risk management (Web Resource 25-6) plans are being developed in Health Canada. Interim implementation occurred in 2009. This guidance calls for risk management plans in the European Union RMP format, though the U.S. REMS format may be used in some cases. It is expected that formal requirements along the lines of the European Union and U.S. risk management systems will come into effect in Canada within the next few years.

Data from the Canada Vigilance Adverse Reaction Online Database is available free (Web Resource 25-7). This unique service covers data in the Canadian adverse reaction database and is updated four times a year. The information is 3 months behind. After reading the instructions and agreeing to the terms and conditions, one can either do an online search or obtain data extract files in a zip file. The online search allows selection by date, seriousness (type of report, e.g., misuse, spontaneous), gender, outcome, age range, brand or active ingredient name, and AR term (MedDRA). The results are immediate. Cases are from Canada only. Results give a line listing of AR number, MA number, date received, age, gender, drug name, and AR codes. Data may be exported or saved.

The summary of the regulations and guidances in force is available at Web Resource 25-8. Clinical trial and Good Clinical Practices (GCP) regulations and guidances are also available (Web Resource 25-9). The major findings (227 out of 354 findings) were for issues in reporting domestic and foreign ADRs within 15 days. Plans are under way to expand the inspections outside of Canada.

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