Regulatory Services in Canada

Health Canada ensures safe and timely access to medicinal products, including medical devices, drugs, and biologics, for the public. The Health Products and Food Branch (HPFB) oversees and controls medicinal product review, assessment, and regulation. The regulatory requirements for obtaining marketing authorization are different for new drugs, medical devices, natural health products, and emergencies and orphan drugs. Each product must obtain its own license that should be compliant with the Good Manufacturing Practices (GMP) requirements and Canada’s Good and Drugs Act. Generic product applicants must submit an Abbreviated New Drug Submission (ANDS) that requires less information compared to the New Drug Submission (NDS) which must be submitted for new drug applications. The Marked Health Products Directorate is responsible for monitoring adverse drug reactions and medication incident data as part of the pharmacovigilance system. Foreign and local manufacturers and importers must submit information regarding adverse reactions including medical device incidents. This is also applicable to clinical trial sponsors. Therefore, the pharmacovigilance and regulatory procedures surrounding medicinal products can be complex and comprehensive for manufacturers to navigate through.

As a leading global contender, DDReg’s regulatory services in Canada provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.