ARCHIVED - Health Canada

Regulations

Expected Results

Performance Measurement Criteria

Results Achieved

Health Products and Food Branch

Food and Drug Regulations
(Addition of Vitamins and Minerals to Foods)

Facilitation of greater consumer choice and industry innovation by revision of regulations on the addition of vitamins and mineral nutrients to foods taking into account the role of nutrient addition to foods, consumer needs and expectations, and industry requests.

Improved nutritional quality of the Canadian food supply.

Availability of increased number of choices of foods with added vitamins and mineral nutrients.

Proposed regulatory amendments are finalized.  Publication of the proposed amendments is anticipated for Fall 2007 for public consultation (pre-publication in the Canada Gazette, Part I).

Food and Drug Regulations
(Enhanced Labelling)

Enhanced protection of allergic consumers through mandatory labelling of specific food allergens, gluten sources and sulphites when present at 10 parts per million or more, on the labels of prepackaged food products, whether they have been added directly or indirectly.

Reduced number of adverse reactions to prepared and prepackaged foods containing specific allergens, gluten sources and sulphites.

Increased consumer awareness of the presence of specific allergens, gluten sources and sulphites in prepared and prepackaged foods.

Proposed regulatory amendments are being developed to implement the new policy.  Publication of the proposed amendments is anticipated for Fall 2007 for public consultation (pre-publication in the Canada Gazette, Part I).

Food and Drug Regulations
(Mandatory Labelling of Raw Ground Meat and Ground Poultry)

Providing safe handling information on the labels of meat products which, due to their raw state, can introduce disease-causing bacteria directly to consumers as well as the food preparation environment.

Reduction of food borne illness as a result of providing safe handling information on the labels of these products.
Increased consumer awareness of the potential microbiological hazards associated with improper handling of ground meat and poultry.

Proposed regulatory amendments are being developed to implement the new policy.

Food and Drug Regulations
(Health Claims)

Addition of two diet-related health claims regarding; 1-fruits, vegetables and whole grains and reduced risk of heart disease and 2- folic acid and reduced risk of neural tube defects to list of claims that manufacturers can use to promote healthy foods.

Healthier eating practices would be monitored through the use of dietary surveys.

The number of foods carrying the approved health claims.

Health Canada posted on its website, the “Position Paper on Five US Health Claims Considered for Use in Canada” during Fall 2006 which details its plan to allow the two new health claims.  Once the policy development is completed, the regulatory amendments will be initiated.

Food and Drug Regulations
(Saccharin)

Saccharin permitted as a food additive in a limited number of foods.

Availability of an additional intense sweetener to allow a wider range of dietetic food products for the benefit of consumers who wish to consume these products.

Health Canada completed its safety evaluation.  Planning for preparation of regulatory amendments.

Food and Drug Regulations
(Caffeine)

Additional label information on levels of caffeine in prepackaged beverages, including energy drinks containing caffeine, to allow consumers to make an informed choice about their caffeine intake.

Increased consumer awareness of the levels of caffeine in beverages sold in Canada.

Health Canada is considering policy options in regard to requirements of additional label information to consumers.

Food and Drug Regulations
(Labelling of Unpasteurized Juice)

Providing additional labelling information regarding consumption of unpasteurized juice products.

Reduction of food borne illness related to the consumption of prepackaged unpasteurized juice products.

Increased consumer awareness of the potential microbiological hazards associated with consumption of unpasteurized juice.

Health Canada conducted public consultation regarding labelling statements and continued its policy development.  Preparation of regulatory amendments will be initiated.

Food and Drug Regulations
(Revisions to Division 12- Prepackaged Water and Ice)

Revision and updating of the safety and labelling requirements for prepackaged water and ice products.

Industry compliance with the revised regulations.

Proposed regulatory amendments are being developed for public consultation (publication in the Canada Gazette, Part I).

Food and Drug Regulations (Prohibition of Importation for Personal Use)

Further restrict the importation of veterinary drugs to include the personal importation of drugs intended to be used in food-producing animals to avoid potentially harmful residues in food products from animals treated with these drugs.

Reduced incidence of harmful drug residues being detected in animals treated with veterinary drugs imported under personal use circumstances.

The Task Force on Personal Use Importation of Veterinary Drugs has been formed to gain the best possible advice from affected stakeholder groups.  The Task Force will provide a report to Health Canada outlining concrete recommendations and strategies to address the issues surrounding the personal importation of veterinary drugs, by the end of August 2007.

Food and Drug Regulations (Carbadox)

Further restrict the sale of products containing Carbadox for sale in Canada to avoid potentially harmful residues in food products from animals treated with this drug.

Reduced availability of food products containing Carbadox residues or its metabolites derived from food-producing animals.

The Canadian Food Inspection Agency enhanced monitoring program for Carbadox will be in place July 2007.  Health Canada is to reassess the need for regulatory action (in a year).

Food and Drug Regulations
amending the Special Access Program (Block Release)

The proposed regulatory provisions will provide Health Canada with a legal mechanism to authorize access to unauthorized drugs for mass distribution (block release) for either an immediate emergency or in anticipation of a health emergency.

 Health Canada (HC) will have a greater capacity to plan and prepare for public health emergencies such as infectious diseases and emerging chemical, biological, radiological and nuclear (CBRN) threats.  Efforts in emergency preparedness activities will ensure a stockpile of drugs be made readily available with proper regulatory authority.

This amendment will provide Health Canada with regulatory authority to allow access to unauthorized drugs in anticipation of a health emergency.

Proposed regulatory amendments are being developed for public consultation (publication in the Canada Gazette, Part I).

Medical Device Regulations (Introduce additional requirements for investigational testing for medical devices)

Minimize risks to participants in medical device investigational testing research, which may lead to health benefits for Canadians.

Decreased risk to participants enrolled in medical device investigational testing research.

Discussion paper developed to obtain input from stakeholders on the issues, analysis and recommended option.

Medical Device Regulations
(Amendment to regulate the reprocessing of single-use devices)

Federal Government is working with provinces and territories to develop approaches in order to mitigate the risks associated with the reprocessing of single-use devices.  

Performance measurement criteria under consideration by the FPT working group.

Food and Drug Regulations
(Schedule A Revision)

Allows industry to label and advertise Schedule A preventative claims approved by Health Canada for non-prescription drugs and Natural Health Products (NHPs). 

Modernization of Schedule A list of disorders and diseases.

Number of approved preventative claims being labelled for non-prescription drugs and NHPs.

Food and Drug Regulations (Regulations amending the data protection provisions)

Amend the data protection provisions of the Food and Drug Regulations to provide effective data protection for eight years for innovator drugs that contain medicinal ingredients not previously approved for sale in Canada.  An additional six months will be provided for submissions that include paediatric studies.

Provide a minimum predictable automatic protection for innovative new drugs so that these products are available to Canadians.

Encourage submission of paediatric information.

The number of drugs listed on register of innovative drugs increases.

Final regulations registered (publication in the Canada Gazette, Part II) in October 2006.

Twenty seven drugs listed on register of innovative drugs, 2 of which will have the paediatric extension.

Food and Drug Regulations
(Amendments to the provisions respecting Human Plasma Collected by Plasmapheresis in Part C, Division 4)

Reflect current methods and practices used to collect human plasma as well as the list of transmissible diseases for which tests must be performed in order to maximize the safety of plasma and plasma donors.

Regulations consistent with current methods and practices used to collect human plasma.

Regulations were finalized using public consultation results (pre-publication in the Canada Gazette, Part I) and were registered (published in the Canada Gazette, Part II) in December 2006.

Food and Drug Regulations
(Safety of Human Cells, Tissues and Organs (CTO) for Transplantation Regulations)

The new CTO Regulations address safety in the processing and handling of these products, resulting in improved protection of the health and safety of Canadian transplant recipients, while at the same time helping to ensure the availability of these life saving and life enhancing products.

Improved protection of the health and safety of Canadian transplant recipients.
Decreased health risks to Canadian recipients of human CTO.

Regulations were finalized using public consultation results (pre-publication in the Canada Gazette, Part I) to be registered (published in the Canada Gazette, Part II) in June 2007.  Regulations will come into force on December 7, 2007.

Food and Drug Regulations
(Amendments to Division 3 respecting Positron Emitting Radiopharmaceuticals)

The amended regulations will eliminate regulatory burden for the performance of certain limited basic clinical research studies, while helping to ensure that patient safety is not compromised.

More appropriate regulatory requirements placed on researchers conducting basic clinical research with positron emitting radio-pharmaceuticals in Canada.

Proposed regulatory amendments are being developed for public consultation (pre-publication in the Canada Gazette, Part I) targeted for Fall 2007.

Food and Drugs Act
(Safety and Quality of Blood and Blood Components Regulations)

Balance the need for safe blood and blood components with the need to ensure the availability of blood and blood components for transfusion. The new regulations will include basic safety requirements, adverse event reporting requirements and a compliance and enforcement strategy.

Greater harmonization achieved in Canada related to collection, handling and post-market surveillance of blood and blood components. Improvement in the protection of the health and safety of Canadian blood and blood component donors and recipients. Requirements updated on a timely basis as new technologies/ products/issues emerge.

Proposed regulatory amendments are being developed for public consultation (pre-publication in the Canada Gazette, Part I) targeted for first half of 2008.

Food and Drugs Act
(Amendments to Part C, Division 8 related to Extraordinary Use New Drug Regulations (EUND))

Formal mechanism to approve products which only contain substantial evidence of clinical effectiveness in animal or in-vitro studies for use in emergency situations and meet emergency preparedness measures, such as the approval and distribution of a vaccine for the treatment and prevention of a pandemic influenza virus.

Availability of products which only contain substantial evidence of clinical effectiveness in animal or in-vitro studies approved though a formal mechanism for use in emergency situations.

Issue Analysis completed. Draft regulations in preparation.

Food and Drug Regulations
(Regulations amending Divisions 1 and 8, Progressive Licensing Framework)

A new regulatory framework that is based on sound science and risk management is being developed.  This will include regulations and guidance documents and will address many of the complex regulatory issues that are inadequately dealt with by the present regulations.

A modern drug licensing framework for Canada that supports access to drugs while continuing to monitor the safety, efficacy, and quality of a drug throughout its lifecycle. 

Stakeholder consultation on the progressive licensing framework was conducted in Fall 2006.

The Progressive Licensing website was launched in 2007. The website contains the concept document, brief discussion papers on topics relating to the regulation of drugs, and reports of workshops with stakeholders.

Food and Drugs Act
Amendment to Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations)

Reflect current safety standards for semen used in assisted conception.

Regulations reflective of current safety standards for semen used in assisted conception.

Significant policy analysis around the changes needed to the regulations has been completed.

Discussion on how to best integrate the Semen Regulations under the Assisted Human Reproduction Act ongoing.

Health Policy Branch

Regulations under the Assisted Human Reproduction Act

New regulations will protect the health and safety of Canadians who use assisted human reproduction (AHR) procedures and ensure that AHR-related research, which may help find treatments for infertility and diseases, takes place in a controlled environment.  Regulated activities include embryo research, clinical and laboratory practices and pre-implantation genetic diagnosis.  The regulatory framework will also regulate reimbursement of expenditures, counselling, and health reporting information and include a licensing regime for AHR activities.

Compliance with regulations measured through inspections, investigations, tracking of complaints and surveys.

In the Spring and Fall of 2006, the Department consulted stakeholders to examine issues related to licensing, clinical and laboratory practices, health reporting information and counselling. 

A public consultation report was posted on Health Canada’s website entitled “Counselling Services Under the Assisted Human Reproduction Act” in March 2007.  Further consultation documents and pre-publication in Canada Gazette, Part I are expected in Fall 2007 and Spring 2008.

Regulations concerning Section 8 of the Assisted Human Reproduction Act

Human reproductive material and embryos (including in vitro embryos) are used only with the donor’s written consent.  The principle of free and informed consent is promoted and applied as a fundamental condition of the use of assisted human reproductive technologies.

Compliance with regulations measured through inspections, investigations, tracking of complaints and surveys.

Regulations were finalized to be registered (published in the Canada Gazette, Part II) June 27, 2007.   These regulations will come into force in December 2007.

Healthy Environments and Consumer Safety Branch

Tobacco Retail Promotion Regulations

Reduced visibility of tobacco promotion at retail.  Achievements will be measured through surveys at retail.

Level of public awareness of tobacco product displays and other tobacco promotions at retail.

Public consultation document released on proposals for further regulating the display and promotion of tobacco and related products at retail.

Tobacco Promotion Regulations prohibiting “light” and “mild” descriptors

Reduce confusion among smokers regarding these descriptors.

Greater awareness that no class of cigarettes is a "safe" alternative.

Number of smokers who believe that "light" and "mild" cigarettes are less harmful than regular cigarettes.

Draft regulations and regulatory impact assessment were prepared.

Introduction of New Tobacco Labelling Requirements

Increased awareness of tobacco-related hazards.

Increased knowledge of tobacco products and their emissions.

Level of public awareness of health hazards related to tobacco use.

Level of knowledge of tobacco products and their emissions.

Creative concepts of health information messages and potential health warning messages for cigars and pipes, and smokeless tobacco products were developed and tested through public opinion research.  This research supports evidence-based messaging in developing the new labelling requirements.

Tobacco Advertising Regulations

Increased awareness of tobacco-related hazards through mandating of new health warnings in advertising.  Awareness will be measured through surveys.

Level of public awareness of health hazards related to tobacco use.

Potential health warning messages for advertisements of cigarettes, cigars and smokeless tobacco products were developed and tested through public opinion research.  This research supports evidence-based messaging in developing health warnings for tobacco advertisements.

Regulations Granting Authorities to New Classes of Practitioners under the Controlled Drugs and Substances Act

Federal legislation will no longer restrict the professional practice of any health profession regulated by provincial or territorial (P/T) authorities, including practitioners of medicine, dentistry, veterinary medicine, paediatric medicine, midwifery, and nurse practitioners, with respect to the use of controlled substances in the treatment of their patients.

Achievement will be measured by improved alignment of federal and P/T regulatory frameworks governing the appropriate use of controlled substances for medical purposes.

Members of the Advisory Committee reviewed a draft policy framework during summer 2006 and a final draft policy framework to be issued in June 2007.  A proposal for new regulations to be published for public consultation (pre-published in the Canada Gazette, Part I) on June 30, 2007 and final regulations are expected to be registered (published in the Canada Gazette, Part II) in late fall 2007.

Pest Management Regulatory Agency(PMRA

Pest Control Products Incident Reporting Regulations

Strengthened health and environmental protection from the use of pesticides through the establishment of a mandatory system for registrants to report incidents which will enable Health Canada's PMRA to identify trends in relation to products, uses and geography.

A mandatory system in place in 2006 for the provision of pesticide incidents information by registrants, when they occur.

A mandatory system for the provision of pesticide incidents information by registrants, when they occur, to come into effect on April 26, 2007.

Pest Control Products Sales Information Reporting Regulations

Strengthened health and environmental protection from the use of pesticides through the establishment of a mandatory system for registrants to report sales information about their pesticides which will enable Health Canada's Pest Management Regulatory Agency (PMRA) to more accurately identify trends in relation to products, uses and geography over time.

A mandatory system in place for the provision of pesticide sales information by registrants in 2006.  Provision of pesticide sales information by registrants in 2007.

A mandatory system is in place since November 26, 2006, for the provision of pesticide sales information by registrants.  Registrants are expected to provide pesticide sales information for year 2007 by the end of June 2008.