Regulatory Initiative: Good Manufacturing Practices for Active Pharmaceutical Ingredients - Forward Regulatory Plan 2012-2014

Title or working title of the regulatory initiative: Good Manufacturing Practices for Active Pharmaceutical Ingredients

Description of the objective:
The quality of the active pharmaceutical ingredient (API) in a drug has a direct effect on the safety and efficacy of that drug. To align internationally, a regulatory proposal will be developed extending the good manufacturing practices (GMP) requirements that are currently set out in the Food and Drug Regulations to all APIs; extending the drug establishment licensing requirements to all API fabricators, packagers/labellers, testers and importers; and creating a new record-keeping requirement to foster the traceability of API from the original fabricator to the dosage-form drug manufacturer.

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.

Canadians had an opportunity to provide input during the  Canada Gazette, Part I public comment period, which closed December 13, 2012.

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.