Regulatory Strategic Guidance

Health Canada’s Regulatory Strategic Guidance - Overview

Generic manufacturers face challenges such as understanding the complexity of Canada’s drug registration guidelines for generic drug approval through an Abbreviated New Drug Submission (ANDS) and complying with the respective guidelines. To overcome them, manufacturers must adopt a robust approach for different types of medicinal products and ensure timely registration and approvals.

Health Canada’s Regulatory strategic guidance involves setting up the right Regulatory roadmap during product development and studies to be performed specific to the dosage form/indication. The submission strategy shall provide guidance on the submission timelines, documents/data required for submission, and the approval process.

Without understanding Canada’s drug registration guidelines, manufacturers may face delays in product registration, which can affect costs and go-to-market timelines. Therefore, Freyr provides clients with accurate Health Canada’s Regulatory strategic guidance for registering generic medicinal products in accordance with Health Canada’s guidance documents, backed up with Regulatory intelligence reports.