Regulatory Initiative: Orphan Drugs for Rare Diseases - Forward Regulatory Plan 2012-2014

Title or working title of the regulatory initiative: Orphan Drugs for Rare Diseases

Description of the objective:
A rare condition is a life-threatening, seriously debilitating, or serious and chronic condition affecting a small number of patients. A new framework that makes the most of informed scientific judgment and enhanced international collaboration will help Canadians with rare diseases get easier access to treatments and information. As part of regulatory modernization and international alignment, a regulatory proposal is being developed to support the designation, authorization and monitoring of drugs used for rare conditions.

Enabling Act:
Food and Drugs Act

Indication of business impacts:
There may be business impacts.  The "One-for-One" Rule and/or the Small Business Lens may apply.

Public consultation opportunities:

Information on previous consultations and details on upcoming opportunities for consultation will be provided on the Health Canada Website for Regulatory Modernization.

Departmental contact:

David K. Lee
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone number: 613-946-6586

Email address: LRM-MLR@hc-sc.gc.ca

For More Information

•  Government-Wide Forward Regulatory Plans
• The  Cabinet Directive on Regulatory Management
• The  Red Tape Reduction Action Plan
• The  Canada-United States Regulatory Cooperation Council

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the  Canada Gazette and  Consulting with Canadians websites.