Active Ingredients

The extension of Good Manufacturing Practices (GMP) to Active Pharmaceutical Ingredients (APIs) has increasingly been recognized as a necessary element in ensuring the overall quality and consistency of marketed drug products. For this reason, the International Conference on Harmonisation (ICH) formed a working group in 1997 to develop a GMP guidance for APIs. Canadian input has been included in this document which was finalized and signed off by the ICH Steering Committee on November 10^th, 2000.

Health Canada, like its international regulatory counterparts, adopted the ICH Q7 Guidance initially on a voluntary basis, and has now implemented internationally aligned regulatory GMP requirements for APIs destined for human use. The amending regulations, published in Canada Gazette, Part II, are linked below. They will come into force on November 8, 2013. For an updated version of the Cost-Benefit Analysis, please send a request for an electronic copy or alternate format of the document to Insp_pol@hc-sc.gc.ca. Please include in the subject line the title "Updated Cost-Benefit Analysis - GMP for API" and whether you would like the document in English or in French.

While the scope of the ICH Q7 Guidance is limited to APIs that will be used in the manufacture of human use pharmaceuticals by virtue of the mandate of ICH, the principles and practices described also have relevance to APIs for veterinary use.

• Notice to Stakeholders - Implementation of Establishment Licensing Requirements for Atypical Active Pharmaceutical Ingredients - November 23, 2017
• Notice to Stakeholders - Establishment Licence Application Deadline - February 8, 2014
• Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients - Coming into force on November 8, 2013
• Notice to Stakeholders - Good Manufacturing Practices for Active Pharmaceutical Ingredients - Implementation Pilot Project for Selected Consumer Health Products
• Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (GUI-0104)
• Active Pharmaceutical Ingredients - Good Manufacturing Practices - Questions and Answers
• Canada Gazette, Part II:
  • Final Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices)
• Canada Gazette, Part I:
  • Proposed Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices)
  • Cost-Benefit Analysis: Regulations Amending the Food and Drug Regulations - Good Manufacturing Practices for Active Ingredients
  • Cost-Benefit Analysis Supplemental: Small Business Lens under the Cabinet Directive on Regulatory Management
• Consultation on the Creation of a regulatory framework for the implementation of Good Manufacturing Practices for active pharmaceutical ingredients [2009-09-17]
• Creation of a regulatory framework for the implementation of good manufacturing practices for active pharmaceutical ingredients [2004-10-28]
• Notice of Intent Published in Canada Gazette Part 1, December 7, 2002 and Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients ICH Topic Q7A [2003-01-17]
• International Conference on Harmonisation - ICH Q7 Guidance (PDF version - 352 K)