Health Canada - SUBMISSIONS FOR GENERIC PARENTERAL DRUGS

/Home/FDA Applications - Protein Formulation/New Drug Applications (NDAs) - Parenteral

The general requirements for all categories are outlined below:
GENERAL REQUIREMENTS (CATEGORY I, II, III AND IV)
-A new drug submission (see Guidelines for Preparing and Filing New Drug Submissions) including:
complete chemistry, manufacturing and quality control data.
-in vitro and in vivo animal studies and clinical trials establishing safety and effectiveness of the product. Data in the public domain may be acceptable as fulfilling this requirement.
-fully annotated Product Monograph, accompanied by appropriate documents cited in the annotations.
-labels and any other labelling material required for the product.
-for products intended to be used in food-producing animals, appropriate residue studies in target species.
SPECIAL REQUIREMENTS, AS SPECIFIED BY CATEGORY:
CATEGORY I PRODUCTS
-roof of pharmaceutical equivalence of the generic and the innovator's product, as marketed in Canada, or
-for products for which pharmaceutical equivalence has not been established, appropriate in vitro and/or in vivo animal studies and/or clinical trials.
CATEGORY II PRODUCTS
-proof of pharmaceutical equivalence of the generic and the innovator's products as marketed in Canada. A product will not be considered pharmaceutically equivalent if
-any of the nonmedicinal ingredients are not generally accepted for such preparations, or
-the quantity of any of the nonmedicinal ingredients falls outside the range acceptable to the Directorate;
or
-for products for which pharmaceutical equivalence has not been established, appropriate in vitro and/or in vivo animal studies and/or clinical trials.
CATEGORY III PRODUCTS
-complete information on the source of the oil, the description of the purification process, and the analytical profile of the oil, and
-proof of pharmaceutical equivalence of the generic and the innovator's product as marketed in Canada. A product will not be considered pharmaceutically equivalent if
-any of the nonmedicinal ingredients are not generally accepted for such preparations, or
-the quantity of any nonmedicinal ingredient falls outside the range acceptable to the Directorate, or
-the oil used is different from that used in the innovator's product;
or
-for products for which pharmaceutical equivalence has not been established, appropriate in vitro and/or in vivo animal studies and/or clinical trials.
CATEGORY IV PRODUCTS
In view of the particular considerations that may apply to these products, a written opinion on special requirements for individual products will be provided on request, upon submission of chemistry and manufacturing data, and proposed labelling.
A full submission will normally be required for all drugs subject to Schedule D.