Biotechnology-Derived Antibody–Drug Conjugates (ADCs) in Oncology: Regulatory Pathway from Development to Submission of a New Drug Submission (NDS) in Canada

Antibody–drug conjugates (ADCs) are a rapidly evolving class of targeted oncology therapeutics that combine the specificity of monoclonal antibodies with the cytotoxic potency of small-molecule payloads. ADCs offer a precision approach to cancer therapy by delivering drugs directly to tumour cells while minimizing systemic toxicity. This paper reviews the structure, mechanism of action, and regulatory considerations for ADCs in Canada, with a focus on the New Drug Submission (NDS) pathway. Key aspects of Chemistry, Manufacturing, and Controls (CMC), as well as Health Canada’s regulatory framework, including Schedule D classification, Good Manufacturing Practices (GMP), and expedited pathways such as Priority Review and Notice of Compliance with Conditions (NOC/c), are discussed. Understanding these requirements is essential for sponsors to ensure regulatory compliance and facilitate timely access to novel ADC therapies.