Regulatory Affairs Services Provider 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.