Topics
	Active Pharmaceutical Ingredients
	Compliance Inspections of Pharmacies
	Disinfectants
	Guidance Documents, Directives & Policies

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.

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.

Public Warning / Advisories

• Advisories for Health Professionals or Consumers

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• Draft Guidance For Industry - Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names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

Drug Product Database

Drug Establishment Licences

• Companies that hold a Drug Establishment Licence
• Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
• Drug Establishment Licence Application: Form and Instructions
• Conditions of Acceptance of Foreign Inspection Reports for Listing Foreign Sites on Canadian Establishment Licences
• Fee Reduction Request for Drug Establishment Licence
• Guidance Document on Drug Establishment Licences and Establishment Licensing Fees

Access to Medicine "The Jean Chrétien Pledge to Africa"

• Inspection Strategy for Canada's Access to Medicines Regime (POL-0055)
• Guidance for Pre-manufacturing and Pre-exportation Notifications under Canada's Access to Medicines Regime (GUIDE-0072)

Post-Market Reporting Compliance - Drug Inspection

• Summary Report of the Post-Market Reporting Compliance Inspections of Drug Manufacturers Conducted from September 1, 2004, to August 31, 2005
• Risk Classification of Post-Market Reporting Compliance Observations (GUI-0063)
• Inspection Strategy for Post-Market Surveillance (POL-0041)

Compliance Inspections of Pharmacies

• Summary Report of the Compliance Inspections of Canadian Pharmacy Sites Involved in the Sale of Prescription Drugs Via the Internet or Via Distance Dispensing
• Letter to Pharmacists / Obligations of Pharmacists under the Food and Drugs Act and Food and Drug Regulations
• Fact Sheet
• Frequently Asked Questions
• Reminder of obligations with respect to the advertising and sale of drugs

Good Clinical Practices

• Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043)
• Guidance for Records Related to Clinical Trials (GUIDE-0068)
• Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines: Manufacture of Drugs Used in Clinical Trials
• Summary Report of the Inspections of Clinical Trials Conducted Under Voluntary Phase
• Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004
• Regulations Amending the Food and Drug Regulations (1024 - Clinical Trials)
• Inspection Strategy
• Involvement and Communications Feedback Form
• International Conference on Harmonization GCP - ICH E6

Export and Import

• Policy on Importations of Drugs for Human Use including Natural Health Products into Canada (POL-0019)
• Guidance document on Commercial Importation and Exportation of Drugs in Dosage Form under the Food and Drugs Act
• Q & A on Commercial Importation and Exportation of Drugs in Dosage form
• Request for Stamping
• Taking Medicine Across Borders

Active Pharmaceutical Ingredients

• Letter to Stakeholders - Creation of a Regulatory Framework for the Implementation of Good Manufacturing Practices for Active Pharmaceutical Ingredients
• Notice of Intent Published in Canada Gazette Part 1, December 7, 2002 and Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients ICH Topic Q7A
• International Conference on Harmonization - ICH Q7A Guidance

Veterinary

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

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)

Recalls

• Drug and Medical Device Recall Listings
• Health Products and Food Branch Inspectorate - Recall Policy
  (POL-0016)
• Product Recall Procedures

Enforcement Guides and Policies

• Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research Policy (POL-0053)
  • Guidance document: Factors Considered in the Assessment of the Risks involved in the Use of Positron Emitting Radiopharmaceuticals in Basic Research involving Humans
• Quality System Framework 2005
• Compliance and Enforcement Policy (POL-0001), Version 2
• GMP Inspection Policy for Canadian Drug Establishment (POL-0011)
• Drug Identification Number (DIN) Enforcement Policy (POL-0040)
• Schedule A and Section 3: Guidance Document