Canadian Regulations amending the Food and Drug Regulations (Improving Access to Generics)

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

Description
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

Notifying member: Canada

Notification: G/TBT/N/CAN/581

Objective tag
Consumer information, labelling

Objective
The objectives of the proposed regulations include the following:

Agency responsible
Department of Health

Timing:

• Submission: 01/04/2019
• Reception: 01/04/2019
• Distribution: 02/04/2019
• Final date for comments: 07/06/2019
• Proposed date of adoption: N/A