International

Cooperative Agreements and Activities

• Closer ties on medicines safety between European and Canadian regulatory authorities

MRA - Mutual Recognition Agreements on Drugs/Medicinal Products Good Manufacturing Practices Compliance Programmes

• Background
• MRAs Updates
• Internationally Harmonized Requirements for Batch Certification
• Standard Operational Procedure for the Determination of Equivalency of Inspection Methods

Partnerships

• PIC/S - Pharmaceutical Inspection Co-operation Scheme
  • PIC/S Annex 17: Parametric release
  • http://www.picscheme.org
• WHO - World Health Organization
  • http://www.who.int/home-page/
• ICH - International Conference on Harmonization
  • http://www.ich.org
• GHTF - Global Harmonization Task Force
  • http://www.ghtf.org/
• OMCL - Official Medicines Control Laboratories

Regulatory Agencies

• FDA - Food and Drug Administration - United States of America
• TGA - Therapeutic Goods Administration - Australia
• AGENCE Francaise de Securite Sanitaire des Produits de Sante - France
• Medical Product Agency - Sweden
• Medicines Control Agency - United Kingdom
• European Commission
• European Agency for the Evaluation of Medicinal Products

Export and Import

• Guidance Document on the Application for Certificate of a Pharmaceutical Product (GUIDE-0024) [2011-02-04]
• Export Certificate (FRM-0176)
• Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) (August 1, 2009)
  • Cover Letter
• Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported
• PIC/S Annex 1: Explanatory Notes for Industry on the Preparation of a Site Master file (January 18, 2008)
• Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use
• Request for Stamping