Drug Products (ICS: 11.120)

Regulations amending the Food and Drug Regulations (Improving Access to Generics) (24 pages, available in English and French).

The regulatory proposal seeks to address cases where generic drug products sometimes differ from their Canadian Reference Product (CRP) (e.g., a different salt, hydrate, or solvate of the medicinal ingredient), leading to difficulties in determining whether drugs could or could not be approved via the Abbreviated New Drug Submission (ANDS) pathway. In certain cases, in both generic and brand name drugs, it is possible that there is a change in the form of a medicinal ingredient during manufacturing of a drug. This type of change is referred to as an “in-situ change.” In such cases, the form of the medicinal ingredient in the dosage form is different from the form of the “input ingredient” used in the manufacturing process (the active pharmaceutical ingredient). The regulatory proposal also suggests consequential changes to ensure the definition of  ‘new active substance’ remains aligned with the definition of ‘innovative drug’; and, the definition of ”new active substance” in the Fees in Respect of Drugs and Medical Devices Regulations remains aligned with the definition of “innovative drug” in the Food and Drug Regulations (FDR).