Health Canada Expands Pilot Project on Foreign Reviews to Aid Assessments

Health Canada has expanded the scope of a pilot project that uses foreign drug reviews to aid in its assessment of new drug submissions, also revising the draft guidance under which the pilot operates. In some cases, the amount and quality of information available from a foreign counterpart, such as the FDA or European Medicines Agency, may expedite the review period, the agency said. But marketing authorization in Canada will not be granted solely on the basis of a foreign regulator’s review and decision, it added.
International Pharmaceutical Regulatory Monitor