Health Canada Policy on Identical Medical Ingredients for Generics

On July 9, 2003, Health Canada announced the final version of its policy Interpretation of "Identical Medicinal Ingredient". The policy lays down the principles to determine if medicinal ingredients are considered "identical" or "non-identical".   This is used in establishing the pharmaceutical equivalence of dosage forms within the meaning of the term "identical medicinal ingredient" as mentioned in Section C.08.001 of the Food and Drug Regulations, and thus which products will be treated as generic equivalents of previously approved drugs. In accordance with the policy, anhydrous, anhydrate and the various hydrated forms of the same medicinal ingredient will generally be considered to be identical, and unsolvated and the various solvated forms of the same medicinal ingredient will also generally be considered to be identical. However, different complexes, esters, salts and isomers of the same medicinal ingredient will be considered to be non-identical, even if the activity of the product is the same. To download the finalized policy, see: http://makeashorterlink.com/?T28B64BF5. To download the cited case, see: http://decisions.fct-cf.gc.ca/fct/2003/2003fct542.html. Summary by: Kathryn Schubert If you have questions about the Food and Drug Regulations, contact Gord Jepson (gjepson@dww.com).