Health Canada Wants to Regionalize Vaccine Licensing

June 12, 2015

Health Canada released draft guidance harmonizing requirements for vaccine licensing in the Americas.

The guidance, which was developed by the Pan American Health Organization, applies to all human vaccines and is organized into modules, including requirements for preparing summaries of common technical documents, summarizing quality, and preparing nonclinical and clinical study reports.

The agency specifically requires that any vaccine supplied with a medical device include a description of the device, its manufacturer and confirmation that it’s been approved for use.

The draft updates a previous version to align it with the International Harmonisation Conference’s CTD format. A number of countries, including Canada, had complained that the text’s deviation from ICH CTD format posed a major challenge to compliance.

Health Canada says the PAHO guidance will aid in licensing and availability of vaccines and ensure more efficient use of agency and industry resources.

Comments are due to Health Canada by Aug. 1. Read the draft guidance at www.fdanews.com/06-08-15-HealthCanada.pdf. — Charlotte Astor