Awareness and educational session for medical device industry on Health Canada's Inspection Program (2006-07)
CAPRA (Canadian Association of Professional Regulatory Affairs) Workshop - Montréal (2006-07)
CAPRA (Canadian Association of Professional Regulatory Affairs) Workshop - Toronto (2006-07)
Clinical Trials Regulatory Framework Review - national consultations (2006-07)
Grade 9 Biotechnology Teacher's Kit - Ottawa Carleton District School Board Science Professional Development Day (2006-07)
Information workshop to the food industry on improvement of allergen prevention practices (2005-06)
MedEffect Web site (2005-06)
Natural Health Products Research Program - Focused Consultation on Fatty Acids and Essential Fatty Acids (2005-06)
Progressive Licensing Framework Expert Model Development Meeting (2006-07)
Progressive Licensing Framework Open Space Workshop (2006-07)
Registration and Disclosure of Clinical Trials (2005-06)
Measures to help ensure Canadians' continued access to an adequate supply of safe and affordable drugs (2005-06)
Training workshop on the preparation of Novel Food Submissions (2006-07)

Technical consultation

A multi-stakeholder task force, co-chaired by Health Canada and the Heart and Stroke Foundation of Canada, on healthier alternatives and strategies to eliminate or reduce processed trans fat (2005-06)
Awareness and educational session for medical device industry on Health Canada's Inspection Program (2006-07)
CAPRA (Canadian Association of Professional Regulatory Affairs) Education Day (2006-07)
Clinical Trials Regulatory Framework Review - national consultations (2006-07)
Consultation on Health Canada's revised document on antimicrobial categorization (2006-07)
Consultation on revised mercury risk management strategy (2006-07)
Consumer Advertising Guidelines for Marketed Health Products for Non-Prescription Drugs including Natural Health Products (2006-07)
Draft guidance document: Reconsideration of final decisions issued for human drug submissions (2005-06)
Draft guidance for industry: Clinical assessment of abuse liability for drugs with central nervous system activity (2006-07)
Five U.S. generic health claims considered for use in Canada (2006-07)
Good Guidance Practices Manual for Therapeutic Products (2006-07)
Grade 9 Biotechnology Teacher's Kit - Ottawa Carleton District School Board Science Professional Development Day (2006-07)
International Conference on Harmonization (ICH) draft 2 guidance: Q9 Quality Risk Management (2005-06)
International Conference on Harmonization (ICH) draft 2 guidance: E2B(M) Second Revision of the ICH Guidance on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (2005-06)
International Conference on Harmonization (ICH) draft 2 guidance: M5 Data Elements and Standards for Drug Dictionaries (2005-06)
International Conference on Harmonization (ICH) draft 2 guidance: S7B Revised Draft - The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (2005-06)
International Conference on Harmonization (ICH) draft 2 guidance: E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (2005-06)
International Conference on Harmonization (ICH) draft 2 guidance: Q8 Pharmaceutical Development (2005-06)
International Conference on Harmonization (ICH) draft 2 guidance: S8 - Immunotoxicity Studies for Human Pharmaceuticals (2005-06)
Meeting with le Réseau québécois des villes et villages en santé (2006-07)
Natural Health Products Guidance monographs/document (2005-06)
Natural Health Products product monographs (2005-06)
Natural Health Products Research Program (NHPRP) - Focused consultation on fatty acids and essential fatty acids (2005-06)
Options for improving public access to information on clinical trials of health products in Canada (2006-07)
Qualitative research on layout, comprehensiveness and understanding of content in a draft Food Guide Resource for Intermediaries (2006-07)
Qualitative research with triads on Food Guide consumer resource (2006-07)
Towards a National Regulatory Framework for Whole Blood and Blood Components (2006-07)
Usability testing of Food Guide Web site mock-ups - draft #2 (2006-07)
Usability testing of My Food Guide Web site mock-ups - draft #2 (2006-07)
Use of international reviews in the Biologics and Genetics Therapies Directorate's submission review process (2005-06)
Veterinary International Cooperation on Harmonization guidelines (2005-06)
VICH GL 42: International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products Guidelines (2006-07)
VICH GL 30: International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products Guidelines (2006-07)
VICH GL 24: International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products Guidelines (2006-07)

Focus group

Animal Biotechnology (2006-07)
Clinical Trials Regulatory Framework Review - national consultations (2006-07)
Draft of the revised Canada's Food Guide to Healthy Eating (2005-06)
Grade 9 Biotechnology Teacher's Kit - Ottawa Carleton District School Board Science Professional Development Day (2006-07)
MedEffect - Stakeholder engagement and consultation (internal and external) (2005-06)
National pharmaceuticals strategy working conference on strengthening the evaluation of real world safety and effectiveness of drug products (2005-06)
Qualitative research on layout, comprehensiveness, and understanding of content in a draft Food Guide Resource for Intermediaries (2006-07)
Qualitative research with triads on the Food Guides Consumer Resource (2006-07)
Qualitative study on the Natural Health Products Directorate's public education and outreach program with stakeholders (2005-06)
Usability of MedEffect Web site and the adverse reaction reporting form (2005-06)
Usability testing of Food Guide Web site mock-ups (2005-06)

Bilateral meeting

Ayurvedic stakeholder information session and outreach (2005-06)
Blueprint for Renewal bilateral meetings (2006-07)
Bulk Natural Health Product Policy (2006-07)
Consultation on revised mercury risk management strategy (2006-07)
MedEffect - Stakeholder engagement and consultation (internal and external) (2005-06)
MedEffect Web site (2005-06)
Meeting with le Réseau québécois des villes et villages en santé (2006-07)
Meeting with provincial and territorial governments on the development of a national strategy on public health outcomes for food safety and nutritional quality (2005-06)
Nuclear Medicine Alliance/Canadian Society of Nuclear Medicine (2006-07)
Special Access Program (SAP) Comprehensive Review, Guidance Document, Policy/Regulatory Review (2006-07)

Public meeting

Ayurvedic stakeholder information session and outreach (2005-06)
Development of Canadian input into the elaboration of world-wide Codex standards for food safety, nutrition, and quality (2006-07)
Food Guide Regional Meetings - post launch (2006-07)
Health Canada International Symposium on Drug, Food, and Natural Health Product Interactions (2005-06)
MedEffect Web site (2005-06)
Stakeholder consultation on draft content for the revised Canada's Food Guide to Healthy Eating (2005-06)
Stakeholder meeting on the reprocessing of single-use medical devices (2005-06)
Stakeholder regional meetings on draft content for the revised Canada's Food Guide to Healthy Eating (2005-06)

Roundtable

Blueprint for Renewal Assistant Deputy Minister Regional Tour (2006-07)
Consultation on revised mercury risk management strategy (2006-07)
Consultation on the development of environmental assessment regulations for substances contained in products regulated under the Food and Drug Act (2005-06)
Consumer Advertising Guidelines for Marketed Health Products for Non-Prescription Drugs including Natural Health Products (2006-07)
MedEffect Web site (2005-06)
Natural Health Products Research Program - Focused Consultation on Fatty Acids and Essential Fatty Acids (2005-06)
Measures to help ensure Canadians' continued access to an adequate supply of safe and affordable drugs (2005-06)

Dialogue

MedEffect - Stakeholder engagement and consultation (internal and external) (2005-06)
Nuclear Medicine Alliance/Canadian Society of Nuclear Medicine (2006-07)
Stakeholder consultation on draft content for the revised Canada's Food Guide to Healthy Eating (2005-06)
Stakeholder Regional Meetings on draft content for the revised Canada's Food Guide to Healthy Eating (2005-06)

Electronic dialogue

Blueprint for Renewal electronic consultation (2006-07)
Natural Health Products Regulatory Review (2006-07)
HPFB Review of Regulated Products: Policy on Public Input (2005-07)

Working group

MedEffect - Stakeholder engagement and consultation (internal and external) (2005-06)
MedEffect Web site (2005-06)
Environmental Assessment Working Group (2006-07)

Advisory bodies

A multi-stakeholder task force, co-chaired by Health Canada and Heart and Stroke Foundation of Canada, on healthier alternatives and strategies to eliminate or reduce processed trans fat (2005-06)
Bulk Natural Health Product Policy (2006-07)
Dispute Avoidance and Resolution Policy for Natural Health Products (2006-07)
Expert Advisory Committee on Cells, Tissues, and Organ Regulation (2006-07)
MedEffect Web site (2005-06)
Natural Health Products monographs (2006-07)
Natural Health Product Regulations guidance documents (2006-07)
Reprocessing of Single-Use Medical Devices (2005-06)

Other types of face-to-face activities

Blueprint for Renewal electronic consultation (2006-07)
Clinical Trials Regulatory Framework Review - national consultations (2006-07)
Consumer Advertising Guidelines for Marketed Health Products for Non-Prescription Drugs including Natural Health Products (2006-07)
Executive interviews with intermediaries who promote healthy eating in multicultural communities (2005-06)
Expert Advisory Committee on Cells, Tissues, and Organ Regulation (2006-07)
Food Guide Regional Meetings - post launch (2006-07)
Health Canada booth at the BioMedex Industry Trade Show (2006-07)]
Partnership with the University of Ottawa for the Health Canada International Symposium on Drug, Food, and Natural Health Product Interactions (2005-06)

Other types of activities

Mail-outs for feedback

Animal Livestock Cloning for Food Use (2005-06)
Bulk Natural Health Product Policy (2006-07)
Clinical Trials Regulatory Framework Review - national consultations (2006-07)
Consumer Advertising Guidelines for Marketed Health Products for Non-Prescription Drugs including Natural Health Products (2006-07)
Development of Canadian input into elaboration of world-wide Codex standards for food safety, nutrition, and quality (2006-07)
Draft guidance for industry: Impurities in Existing Drug Substances and Products (2005-06)
Draft guidance for industry: Changes in Product Colour or Markings (2005-06)
Draft guidance for industry: Product Monographs of Non-Contraceptive Estrogen/Progestin-containing Products (2005-06)
Homeopathic Medicine Definition (2006-07)
Interim compounding material policy for Natural Health Products (2005-06)
Interim raw material policy for Natural Health Products (2005-06)
Joint Health Canada/European Union Guidance on Pharmaceutical Quality of Inhalation and Nasal Products (2005-06)
Labeling of Unpasteurized/Pasteurized Fruit Juice/Cider (2005-06)
Mandatory Reporting of Adverse Reactions by Health Professionals (2005-06)
Modifications to Health Canada's Unpasteurized Juice Policy (2006-07)
Natural Health Products Monographs (2006-07)
Pharmacogenomics Guidance (2005-06)
Project 743 - Non-medicinal ingredients: Requirements for listing on product labels (2006-07)
Raw Milk Cheese Code of Practice (2006-07)
Silicone Gel-filled Breast Implants (2005-06)

Web postings for feedback

Amendment to the Food and Drug Regulations - Addition of two medicinal ingredients to Schedule F (2005-06)
Audit Program Frequently Asked Questions document (2006-07)
Blueprint for Renewal electronic consultation (2006-07)
Clinical Trial Application templates (2006-07)
Clinical Trials Regulatory Framework Review - national consultations (2006-07)
Consumer Advertising Guidelines for Marketed Health Products for Non-Prescription Drugs including Natural Health Products (2006-07)
Development of Canadian input into elaboration of world-wide Codex standards for food safety, nutrition, and quality (2006-07)
Draft guidance document: Reconsideration of Final Decisions Issued for Human Drug Submissions (2005-06)
Draft guidance for industry: Impurities in Existing Drug Substances and Products (2005-06)
Draft guidance for industry: Basic Product Monograph Information for Non-steroidal Anti-Inflammatory Drugs (2005-06)
Draft guidance for industry: Changes in Product Colour or Markings (2005-06)
Draft guidance for industry: Clinical Assessment of Abuse Liability for Drugs with Central Nervous System Activity (2006-07)
Draft guidance for industry: Guide for the Analysis and Review of QT/QTc Interval Data (2006-07)
Draft guidance for industry: Instructions to be included with reusable medical devices (2006-07)
Draft guidance for industry: Patented Medicines (Notice of Compliance Regulations) (2006-07)
Draft guidance for industry: Product Monographs of Non-Contraceptive Estrogen/Progestin-containing Products (2005-06)
Draft guidance for Industry: QT/QTc Interval Prolongation: Guidance for Product Monograph Content (2006-07)
Draft guidance for Industry: Reporting Adverse Reactions to Marketed Health Products (2005-06)
Draft guidelines: Good Manufacturing Practices Requirements for Positron-Emitting Radio-pharmaceuticals (2005-06)
Draft: Notice of Compliance (NOC) Changes Project (2006-07)
Five U.S. generic health claims considered for use in Canada (2006-07)
Good Guidance Practices Manual for Therapeutic Products (2006-07)
Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031) (2006-07)
Good Manufacturing Practices (GMP) Guidelines (GUI-0001) (2006-07)
Health Canada International Symposium on Drug, Food, and Natural Health Product Interactions (2005-06)
HPFB Review of Regulated Products: Policy on Public Input (2006-07)
International Conference on Harmonization (ICH) Guidance E15: Pharmacogenomics (Step 2) (2006-07)
International Conference on Harmonization (ICH) Guidance Q4B:
Regulatory acceptance of analytical procedures and/or acceptance criteria and Annex 1, residue on ignition/sulphated ash (2006-07)
Inspection Strategy for the Canadian Access to Medicines Regime (POL-0055) (2006-07)
Joint Health Canada/European Union Guidance on Pharmaceutical Quality of Inhalation and Nasal Products (2005-06)
Labelling of Unpasteurized/Pasteurized Fruit Juice/Cider (2005-06)
Letter to Quality Systems Auditing Organizations (2006-07)
Mandatory Reporting of Adverse Reactions by Health Professionals (2005-06)
Manufacturing and Compounding Drug Products in Canada (POL-0051) (2006-07)
MedEffect - Stakeholder engagement and consultation (internal and external) (2005-06)
MedEffect Web site (2005-06)
Modifications to Health Canada's Unpasteurized Juice Policy (2006-07)
Pharmacogenomics Guidance (2005-06)
Process Validation Guidelines for Terminal Sterilization Process for Pharmaceutical Products (GUI-0074) (2006-07)
Project 743 - Non-medicinal ingredients: Requirements for listing on product labels (2006-07)
Project 1330 - Addition of sibutramine to Schedule F (2005-06)
Project 1370 - Addition of nicotine lozenge to Schedule F (2005-06)
Project 1405 - Addition of seven medicinal ingredients to Schedule F (2005-06)
Project 1439 - Addition of five medicinal ingredients to Schedule F (2005-06)
Project 1445 - Addition of alefacept to Schedule F (2005-06)
Project 1448 - Addition of danofloxacin to Schedule F (2005-06)
Project 1451 - Additional of medicinal ingredients to Schedule F (2005-06)
Project 1452 - Addition of medicinal ingredients to Schedule F (2005-06)
Project 1476 - Addition of medicinal ingredients to Schedule F (2005-06)
Public Forum on Silicone Gel-filled Breast Implants (2005-06)
Release of revised Form IV and Form V, pertaining to the Patented Medicines (Notice of Compliance) Regulations (2006-07)

Publications in Canada Gazette Part 1

Amendments to Division 2 of the Food and Drug Regulations (2006-07)
Project 1184 - Modafinil (2005-06)
Project 1385 - Schedule F exemptions for Vitamin K (2005-06)
Project 1421 - Removal of clobetasone from Schedule F (2005-06)
Project 1474 - Schedule F (2005-06)
Project 1482 - Data protection (2006-07)
Project 1510 - Schedule F exemption (2006-07)

Survey

MedEffect Web site (2005-06)
National Pharmaceuticals Strategy (NPS) working conference on strengthening the evaluation of real-world safety and effectiveness of drug products (2005-06)
On-line and phone survey of stakeholders consultation on draft content for the revised Canada's Food Guide to Healthy Eating (2005-06)
Qualitative study on public education and outreach program with natural health products stakeholders (2005-06)
Registration and Disclosure of Clinical Trials (2005-06)

Other

Food Guide Regional Meetings - Post Launch (2006-07)
Report and feedback on the Options Analysis Paper - An environmental assessment regime for the new substances in products regulated under the Food and Drugs Act (2005-06)
Usability testing of Food Guide Web site mock-ups - draft #2 (2006-07)
Usability testing of My Food Guide Web site mock-ups - draft #2 (2006-07)

Ongoing public involvement

Scientific advisory bodies

Attention Deficit/Hyperactivity Disorder. Provides medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-06)
Bill C9. Provides medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes and suggests issue/options to be explored. (2006-07)
Medical Devices Used in the Cardiovascular System. Provides ongoing advice on medical devices used in the cardiovascular system. (2005-07)
Metabolic and Endocrine Therapies. Provides medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-07)
Musculoskeletal Therapies. Provides ongoing medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-07)
Neurological Therapies. Provides ongoing medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-07)
Oncology subgroup for pharmaceutical submission issues. Provides medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-06)
Pediatrics. Provides ongoing medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-07)
Respiratory and Allergy Technologies. Provides medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-07)

Expert advisory bodies

Advisory Committee on Management. Provides the Assistant Deputy Minister and the Branch Executive Committee of HPFB with informed feedback from stakeholders on issues pertaining to HPFB planning, programs, and management. (2005-07)
Antimicrobial Resistance Risk Assessment. Provides expert advice on available risk assessments, methodology, and applications to evaluate the health risks of specific antimicrobial agents and to make evidence-based risk-management decisions on the animal-use of antimicrobial agents, particularly those used in food-producing animals. (2005-07)
Blood Regulations. Provides the Biologics and Genetic Therapies Division with advice on medical and scientific issues relevant to deferral responsibilities within the national blood system. (2005-07)
Cells, Tissues, and Organs Regulations. Provides the Biologics and Genetic Therapies Directorate with advice on developing and implementing proposed regulations. (2005-07)
Dietary Reference Intakes. Provides advice and recommendations on how best to apply the Dietary Reference Intakes. (2005-06)
Food Guide Advisory Committee. Provides advice and guidance on revising Canada's Food Guide to Healthy Eating and supporting materials. (2005-07)

Scientific advisory panels

Scientific advisory panels (SAPs) provide medical, technical, and scientific advice and recommendations on a variety of issues, including the safety and efficacy of some of the products regulated by Health Canada. Panel members are appointed by Health Canada.

Expert Advisory Panel on Aquaculture Veterinary Drugs. Provides input and advice on the decision-making process used by the Veterinary Drugs Directorate to establish interim maximum residue limits and withdrawal periods for needed aquaculture veterinary drugs. (2006-07)
Fentanyl BE Requirements. Provides ongoing medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2006-07)
Hepatoxicity. Provides ongoing medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2006-07)
Human Reproductive Therapies. Provides medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2005-06)
Isotretinoin Expert Working Group. Provides ongoing medical, technical, and scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. Issues and options explored by committee/panel. (2005-07)
Reprocessing of Medical Devices. Provides technical and scientific advice on current and emerging issues for reprocessing of medical devices. (2005-07)

Other panels and working groups

Clinical Trials External Working Group. Provides ongoing medical, technical, scientific advice and recommendations on regulatory issues for drugs in specific therapeutic areas or classes. (2006-07)
Extra-Label Drug Use Advisory Committee. Provides a forum for advice from the stakeholder community on issues related to policy development on extra-label drug use in animals. (2005-07)
Management Advisory Committee for the Natural Health Products Directorate. Provides advice to management on the administration of the natural health products program. (2005-07)
Natural Health Products Directorate Expert Advisory Council. Provides expert advice on issues relating to the safety, quality, and efficacy of natural health products. (2005-07)
Network on Healthy Eating. Provides collaboration, co-operation, and coordination to support healthy eating and nutrition in Canada. (2005-07)
Special Access Program Working Group. Provides input on the issue analysis summary, program guidance document, and discussion paper following a study of the ethical context of SAP's mandate and activities. (2006-07)
Task Force on Personal Importation of Veterinary Drugs. Provides advice on the importing of veterinary drugs for personal use situations and develops recommendations that address the issues raised. (2006-07)
Veterinary Drugs Directorate Minor Uses/Minor Species Working Group. Provides advice on the lack of approved drugs for minor uses/minor species, particularly in food-producing animals. The intention is that this working group will become an advisory committee. (2005-07)
Veterinary Drugs Directorate Stakeholder Committee. Provides a forum for obtaining input from the stakeholder community on key issues that are the responsibility of the Veterinary Drugs Directorate. (2005-07)
Voluntary Statement of Information for Public Involvement Evaluation Working Group. Provides guidance to the Office of Consumer and Public Involvement on the final report of evaluation findings. (2006-07)

Bilateral meetings

Bilateral meetings are used regularly by HPFB to meet with stakeholder groups to discuss regulatory issues. In 2005-07, the Branch met with the following organizations:

BIOTECanada
Canada's Medical Device Technology Companies
Canada's Research-Based Pharmaceutical Companies (Rx&D)
Canadian Association for Pharmacy Distribution Management
Canadian Consumer Specialty Products Association
Canadian Cosmetic, Toiletry and Fragrance Association
Canadian Food Inspection Agency-Food Industry Multi-Stakeholder Committee
Canadian Generic Pharmaceutical Association
Canadian Homeopathic Pharmaceutical Association
Canadian Medical Association
Canadian Pharmacists Association
Canadian Society of Hospital Pharmacists
Compressed Gas Association
Direct Sellers Association
Groupement provincial de l'industrie du médicament
MEDEC: Canada's Medical Device Technology Companies
National Association of Pharmacy Regulatory Authorities
NDMAC
Nuclear Medicine Alliance/Canadian Society of Nuclear Medicine
Advertising Standards Canada

Assistant Deputy Minister stakeholder meetings

Assistant Deputy Minister meetings are stakeholder meetings to discuss stakeholder issues and to take a proactive approach to stakeholder relationship-building. In 2005-07, the ADM met with the following stakeholders: