Drugs

The maintenance and enhancement of health and safety is a responsibility that is shared between government and industry, consumers, healthcare professionals and their respective associations.

Regulated parties that market drugs and medical devices have the primary responsibility for the safety of any product they sell, manufacture, import or distribute to the Canadian public. These regulated parties must comply with all legislative and regulatory requirements.

In this topic…

• Active Ingredient
• Adverse Reaction Information
• Drug Establishment Licences
• Drug Product Database
• Enforcement Guides and Policies
• Good Clinical Practices
• Importation and Exportation
• Guidance Documents, Directives and Policies
• Recalls
• Veterinary

The Health Products and Food Branch Inspectorate (Inspectorate) has the legislative/regulatory authority to conduct compliance and enforcement activities including: the delivery of inspections, investigations, most establishment licensing and related laboratory analysis functions for the HPFB. It also has a responsibility to foster partnerships in the regulatory community, including our international, federal and provincial partners.

On this page

• Public Warning / Advisories
• Active Ingredients
• Adverse Reaction Information
• Canada's Access to Medicines Regime (CAMR)
• Compliance Inspections of Pharmacies
• Disinfectants
• Drug Establishment Licences
• Enforcement Guides and Policies
• Good Clinical Practices
• Good Pharmacovigilance Practices (GVP)
• Recalls
• Veterinary

Public Warning / Advisories

• Impurities found in certain angiotensin II receptor blocker (ARB) products, also known as sartans
• Hospira S.P.A
• Zhejiang Hisun Pharma Company Ltd.
• Advisories for Health Professionals or Consumers
• APIPL/ARPL/IPCA
• Micro Labs
• Dr. Reddy's Laboratories / IPCA Laboratories
• Sri Krishna Pharmaceuticals Ltd

Active Ingredients

• Notice to Stakeholders - Implementation of Establishment Licensing Requirements for Atypical Active Pharmaceutical Ingredients for Veterinary Use
• Notice to Stakeholders - Implementation of Establishment Licensing Requirements for Atypical Active Pharmaceutical Ingredients
• Notice to Stakeholders - Updates to drug establishment licence applications and good manufacturing practice evidence requirements for active pharmaceutical ingredients
• 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

Adverse Reaction Information

• Draft Guidance For Industry - Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names
• Look-alike Sound-alike Health Product Names
• Executive Summary: Look-Alike Sound-Alike (LA/SA) Health Product Names Consultative Workshop

Canada's Access to Medicines Regime (CAMR)

• Inspection Strategy for Canada's Access to Medicines Regime (POL-0055)
• Guidance for Pre-manufacturing and Pre-exportation Notifications (C.07.011) under Canada's Access to Medicines Regime

Compliance Inspections of Pharmacies

• Fact Sheet
• Frequently Asked Questions
• Reminder of obligations with respect to the advertising and sale of drugs

Disinfectants

• Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices Version 2 (GUIDE-0049)
• Canada Gazette Part II (December 15, 2004) Regulations Amending the Food and Drug Regulations (1356 - Disinfectants)

Drug Establishment Licences

• Drug Establishment Licence Application Forms and Instructions (FRM-0033) [2014-10-23]
  • Table A: Foreign Building Conducting Active Pharmaceutical Ingredients Related Licensable Activities
• Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
• Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2011-04-01]
• Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) (August 1, 2009)

Enforcement Guides and Policies

• Quality System Framework - Summary
• Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research Policy (POL-0053)
  • Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies [2014-12-30]
• Compliance and Enforcement Policy (POL-0001)
• Drug Identification Number (DIN) Enforcement Policy (POL-0040)
• GMP Inspection Policy for Canadian Drug Establishments (POL-0011)

Good Clinical Practices

• Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043)
• Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)
• Guidance Document: Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100)
• Inspection Strategy for Clinical Trials
• International Conference on Harmonisation GCP - ICH E6
• Regulations Amending the Food and Drug Regulations (1024 - Clinical Trials)
• Summary Report of Inspections of Clinical Trials conducted from April 2004 to March 2011 [2012-03-28]
• Summary Report of the Inspections of Clinical Trials Conducted Under Voluntary Phase
• Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004

Good Pharmacovigilance Practices (GVP)

• Notice to Stakeholders: Name change for the Post-Market Reporting Compliance (PMRC) inspection program to Good Pharmacovigilance Practices (GVP)
• Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)
• Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063)
• Inspection Strategy for Good Pharmacovigilance Practices for Drugs (POL-0041)
• Summary Report of the Post-Market Reporting Compliance Inspections Conducted from September 1, 2005 to March 31, 2008

Recalls

• Product Recall Procedures

Veterinary

• Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use