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Drugs and Health Products
Compliance and Enforcement
In this section you will find information on public involvement and consultation related to compliance and enforcement activities.
Compliance and enforcement activities are a key element of safeguarding the drugs and health products to which Canadians have access.
Current Consultations
Past Consultations
- Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104) [2012-10-22]
- Consultation: Cleaning Validation Guidance (GUI-0028) [2011-12-16]
- Consultation: Draft Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101) [2011-12]
- Developing a Model for Scheduling Inspections of Cells, Tissues and Organs Programs - Consultation Workbook [2011-12]
- Consultation: Draft Guidance on Process Validation : Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074) [2011-12-16]
- Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031) [2011-09]
- Medical Devices: Reviewing the Medical Devices Inspection Cycle - Consultation Workbook Instruction [2011-08]
- Consultation: Draft Documents for Post-Market Reporting Compliance (PMRC) Inspection Program [2011-07]
- Good Clinical Practices (GCP) Information Sessions - November 2010 [2010-09]
- Good Manufacturing Practices (GMP) - Establishment Licence (EL) Information Sessions [2010-03]
- Request for comments from industry on Draft Risk Classification of Observations to Donor Semen Establishments (GUI-0053) [2010-01]
- Consultation: Regulations Amending the Food and Drug Regulations 1447 - Good Manufacturing Practices [2009-11]
- Consultation on Good Manufacturing Practices- Program Review [2009-09]
- Consultation on the Creation of a regulatory framework for the implementation of Good Manufacturing Practices for active pharmaceutical ingredients [2009-09]
- Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection Program (GUI-0001 related) [2009-08]
- Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection Program [2009-08]
- Consultation: Draft Guide for the Risk Classification of Observations Made During Inspections of Blood Establishments (Revised) [2009-07]
- Consultation: Draft Documents for Medical Devices Program [2009-06]
- Draft Guidance Document: HPFBI Guidelines for Recall of Drug and Natural Health Products (GUIDE-0039) [2008-01]
- Draft Good Manufacturing Practices (GMP) Guideline - 2007 Edition (GUIDE-0001) [2006-12]
