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

• Consultation on the Risk classification guide of observations related to clinical trial inspections of human drugs (GUI-0043) [2021-11-15 - 2021-12-14]
• Notice to stakeholders – Release of draft guidance document for consultation: Annex 3A to the Good Manufacturing Practices Guide [2020-10-07]
• Notice to stakeholders – Draft guidance document for consultation: Guide to Good Manufacturing Practice for Medicinal Products Annex 1: Manufacturing of sterile medicinal products [2020-02-20]
• Notice to stakeholders – Release of draft guidance document for consultation: Annex 4 to the Good manufacturing practices guide – Veterinary drugs [2020-02-19]
• Notice to Stakeholders - Release of Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104) for Consultation [2018-12-31]
• Drug and natural health products recall guide consultation [2018-11-15]
• Consultation on the List of Atypical Active Pharmaceutical Ingredients for Veterinary Use [2018-07-25]

Past Consultations

• Notice to stakeholders – Release of draft guidance document for consultation: Guidelines for environmental control of drugs during storage and transportation (GUI-0069) [2018-12-20]
• Notice to stakeholders – Release of draft guidance documents for consultation: Cleaning validation guide (GUI-0028) and Guide to validating drug dosage forms (GUI-0029) [2018-11-20]
• Consultation and Notice to Stakeholders: Release of Guidance Documents for Consultation: Various good manufacturing practices and drug establishment licensing guidance documents [2017-01-18]
• Notice to Stakeholders - Implementation of Establishment Licensing Requirements for Atypical Active Pharmaceutical Ingredients [2016-12-02]
• Consultation on the Atypical Active Pharmaceutical Ingredients List [2016-12-02]
• Consultation: Invitation to Participate in the Survey for ICH Q7 Constituencies Input for Development of a Question and Answer Document [2013-02-15]
•  Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices)
• Consultation: Cleaning Validation Guidance (GUI-0028) [2011-12-16]
• Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031) [2011-09]
• Consultation: Draft Documents for Post-Market Reporting Compliance (PMRC) Inspection Program [2011-07]
• Good Manufacturing Practices (GMP) - Establishment Licence (EL) Information Sessions [2010-03]
• 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 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 Good Manufacturing Practices (GMP) Guideline - 2007 Edition (GUIDE-0001) [2006-12]