Regulatory Development
As outlined in the Regulatory Roadmap for Health Products and Food, the regulatory frameworks for health products and food are being updated. In parallel with each of the regulatory proposals, Health Canada prepares for consultations and effective implementation. This could include revising guidance documents, training for employees and operational transition planning. The table below tracks current work and consultations underway.
| Project | Legislation / Regulation | Guidance | Other Related Links |
|---|---|---|---|
| Marketing Authorizations for Food Additives | Bill C-38: Division 19, Sections 416-418 | Transition Guide: Understanding and Using the Lists of Permitted Food Additives | Lists of Permitted Food Additives |
| Canada Gazette, Part II: 15 Marketing Authorizations for Food Additives Published 2012-10-24 |
Further information: Amendments to the Food and Drugs Act (Bill C-38) | ||
| Orphan Drug Framework | Ministerial announcement, October 3, 2012 | ||
| Consumer Health Products Framework | Consultation: Consumer Health Product Framework | Ministerial Notice to Stakeholders, June 9, 2014 | |
| Plain Language Labelling | Canada Gazette Part II: Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) Published 2014-06-13 |
Plain Language Labelling Regulations for Prescription Drugs Plain Language Labelling Regulations for Non-prescription drugs |
| Project | Legislation / Regulation | Guidance | Other Related Links |
|---|---|---|---|
| Prescription Drug List | Canada Gazette, Part II: Regulations Amending Certain Regulations Concerning Prescription Drugs Published 2013-06-07 |
Guidance Document - Determining Prescription Status for Human and Veterinary Drugs | Prescription Drug List |
Continue to monitor progress and provide your thoughts and insights by signing up to receive updates, and by checking back on the consultations underway.
Past consultations
- Technical Discussions on Regulatory Modernization for Therapeutic Products
- Progressive Licensing Project
Research initiatives
Useful Tools & References
Page details
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