Several others had specific comments which have been incorporated in the revised policy. Some respondents had a concern that the innovator product marketed in Canada and in another country may differ therapeutically. The policy calls for a full pharmaceutical equivalence between the Canadian and non-Canadian reference products as well as other criteria. It is our position that any remaining difference is not likely to be therapeutically significant for the classes of drugs covered by this policy. The policy is not consistent with the Drugs Directorate's unwillingness to accept foreign reviews for innovative products.
Policy is beneficial only to the generic sector.
The policy is not intended to benefit one sector of the industry over another. It will also apply to changes in innovative formulations involving a bioequivalence study. It is restricted to products marketed in other countries by the Canadian innovator. Criteria 2 is likely to be used to refute bioequivalence of any drug. Criterion 2 is to make provision for the exclusion of dosage forms or ingredients with demonstrated bioavailability problems.