The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs

Canada to Require Foreign Facilities that Produce API to Prove GMP Compliance

Oct. 23, 2015

Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients.

Beginning Nov. 8, 2016, API importers, producers of finished dosage forms that import APIs for use in manufacturing and FDF importers must submit a drug establishment license application to Health Canada affirming GMP compliance.

As part of the application, firms will need to provide the API name, foreign building name, its complete address, GMP compliance status, date of last inspection and inspection type, and activities the facility performs.

Drug establishment license holders can’t import from those buildings until Health Canada approves the application. The agency hopes to turn applications around within 20 days. Importers must also keep proof of compliance at their buildings in Canada and make it available upon request.

Evidence of GMP compliance includes an inspection report with a “compliant” rating issued by Health Canada or inspection reports issued by regulatory partners like the FDA and World Health Organization — as long as the inspections meet Canadian GMPs or ICH Q7 guidelines. In the absence of an inspection report, companies can submit consultant or corporate audits, but only until November 2016, the agency says. After that time, importers can ask Health Canada for an inspection.

Firms should establish written quality agreements with foreign suppliers that clearly identify the foreign API maker and the GMP responsibilities of each party.

The requirements implement 2013 amendments to Canada’s Food and Drug Regulations.

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