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…
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
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- Draft Guidance For Industry - Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names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]
- 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)
- 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)
- Good pharmacovigilance practices inspections
- Notice to Stakeholders: Name change for the Post-Market Reporting Compliance (PMRC) inspection program to Good Pharmacovigilance Practices (GVP)
- Good pharmacovigilance practices guidelines (GUI-0102)
- Risk classification guide for good pharmacovigilance practices observations (GUI-0063)
- Good pharmacovigilance practices inspection approach policy for human drugs (POL-0041)