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Biosimilar biologic drugs A biosimilar biologic drug, or biosimilar, is a biologic drug that is highly similar to a biologic drug that was already authorized for sale (known as the reference biologic drug). Biosimilars may enter the market after the expiry of reference biologic…

Regulatory roadmap for biologic (Schedule D) drugs in Canada This regulatory roadmap gives comprehensive, general information about the regulation of biologic drugs for human use in Canada. All drugs that are marketed in Canada are subject to the Food and Drugs Act and…

Regulatory roadmap for radiopharmaceutical (Schedule C) drugs in Canada From Health Canada This regulatory roadmap gives comprehensive, general information about the regulation of radiopharmaceutical drugs for human use in Canada. All drugs marketed in Canada are subject to the…

Association Meetings: Biologic and Radiopharmaceutical Drugs Directorate The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) hosts bilateral meetings with a number of national stakeholder organizations to discuss and consult on regulatory issues of mutual interest,…

Radiopharmaceuticals, Kits, and Generators: Submission Information for Schedule C Drugs Download the alternative format (PDF format, 1 MB, 129 pages) Organization: Health Canada Published: 2019-08-13 Foreword Guidance documents are meant to provide assistance to industry and…

Archived - Consultation on the Revised Guidance for Industry Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products Notice to Stakeholders Consultation on the Revised Guidance for Industry Preparation of the Quality…

Handbook for health care professionals on biosimilar biologic drugs: Overview Overview About Data requirements Immunogenicity Authorization of biosimilars Monitoring Access to biosimilars Appendices Case studies Disclaimer: Health Canada developed this handbook to inform and…

Notice to stakeholders: Release of guidance document: Information and submission requirements for biosimilar biologic drugs for the addition of an indication where there is no/minimal data required to accompany the submission Health Canada (HC) is pleased to announce the release…

Overview of the Labelling Requirements for Pressurized Containers Containing Biocides A designated container is a disposable metal container that's designed to release pressurized contents through a valve. The valve is manually operated and forms an integral part of the…

About the List of Foreign Regulatory Authorities for Biocides incorporated by reference Effective date: May 31, 2025 On this page Interpreting the list Including authorities on the list Updating the list Interpreting the list Companies may submit an application for a market…