![]() To get these, manufacturers must provide strong evidence of the product's quality, safety, and efficacy as required under Canada's Food and Drugs Act and Regulations. What we doīefore manufacturers can market a product in Canada, under the Food and Drug Regulations, they need to obtain a Drug Identification Number (DIN) and/or a Notice of Compliance. ![]() With senior management support, BRDD is fully committed to continual advancement of the effectiveness of the QMS through improvement of processes and services of the organisation. We accomplish this in a predictable, transparent, and open manner using a Quality Management System (QMS) which is based on requirements of applicable statutes, regulations, policies and guidelines, including the ISO 9001 and ISO 17025 Standards. The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) provides high quality and timely risk-based decisions using currently available scientific and clinical evidence, enabling access to safe, effective, and quality biologics and radiopharmaceuticals for the people of Canada. The Directorate is also the regulatory authority responsible for the Assisted Human Reproduction (AHR) Act and its supporting regulations. ![]() Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD) regulates biological drugs (products made from living sources, including vaccines), radiopharmaceuticals (drugs that have radioactivity), and cells, tissues and organs for human use in Canada.
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