Treasury Board of Canada Secretariat
www.tbs-sct.gc.ca
Common menu bar links
Breadcrumb Trail
ARCHIVED - Health Canada
This page has been archived.
Archived Content
Information identified as archived on the Web is for reference, research or recordkeeping purposes. It has not been altered or updated after the date of archiving. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats on the "Contact Us" page.
Progress Toward the Department's Regulatory Plan
| Regulators | Expected Results |
|---|---|
| Program Activity: Canadian Assisted Human Reproduction | |
| Regulations under the Assisted Human Reproduction Act (Subsection 14(2)b), Counselling) |
The Assisted Human Reproduction Act requires that counselling services are made available to the donor before donating human reproductive material or in vitro embryos. The regulations will provide the details respecting the counselling services. |
| Regulations under the Assisted Human Reproduction Act (Section 40 to Section 43, Licensing) |
The Assisted Human Reproduction (AHR) Act requires that all persons undertaking controlled activities (i.e., assisted human reproduction procedure such as in vitro fertilization) must obtain a license to undertake those activities and undertake those activities in a licensed premises. The AHR regulations will detail the requirements for obtaining a license such as the administrative framework for the activities and the premises, and qualifications. |
| Regulations under the Assisted Human Reproduction Act (Section 10, Clinical and Laboratory Activities) |
Section 10 of the Assisted Human Reproduction Act specifies that controlled activities must be performed in accordance with a license and regulations. The regulations, with respect to controlled activities, will define the conduct of core activities involved in the practice of assisted human reproduction (e.g., in vitro fertilization, embryo transfer). These regulations will address the protection and promotion of human health, safety, dignity and rights related to the conduct of the controlled activities. |
| Regulations under the Assisted Human Reproduction Act (Section 14 to Section 16, Health Reporting Information for Controlled Activities) |
These regulations will specify the health reporting information that Assisted Human Reproduction (AHR) clinics will need to collect prior to each AHR procedure. These regulations will also address retention, use, disclosure and destruction of health reporting information. |
| Regulations under the Assisted Human Reproduction Act (Section 12, Reimbursement of Expenditures) |
Section 12 of the Assisted Human Reproduction (AHR) Act allows for the reimbursement of expenditures to donors of human reproductive material (i.e., semen, oocytes) and surrogate mothers. These AHR regulations will specify the reasonable expenditures that can be reimbursed. |
| Program Activity: Food and Nutrition | |
| 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. |
| Food and Drug Regulations (Enhanced Labelling) |
The proposed amendment will enhance protection of allergic consumers through mandatory labelling, on the labels of pre-packaged food products, of specific food allergens, gluten sources and sulphites when present at 10 parts per million or more, whether they have been added directly or indirectly. |
| Food and Drug Regulations (Mandatory Labelling of Raw Ground Meat and Ground Poultry) |
The proposed regulation will reduce the risk of food-borne illness as a result of providing safe handling information on the labels of these products which, due to their raw state, can introduce disease-causing bacteria to the food preparation environment. |
| Program Activity: Health Products | |
| Food and Drug Regulations (Health Claims) |
The proposed amendment allows the addition of two diet-related health claims to the list of claims manufacturers can use to promote healthy foods regarding: fruits, vegetables and whole grains and reduced risk of heart disease; and folic acid and reduced risk of neural tube defects. |
| Food and Drug Regulations (Progressive Licensing Framework) |
A new regulatory framework based on sound science and risk management is being developed, including revised requirements for initial licensing of new products, provisions allowing for conditions of licensing (e.g., post-market commitments), regulations for the content and revisions of product monographs, provisions for continual evaluation and re-evaluation of licenses, new enforcement and compliance tools, regulations for the issuance of risk communication tools, and provisions for public involvement in the regulatory process. |
| Food and Drug Regulations (Regulations amending Division 1 requirements for Non-Medicinal Ingredients in Drug Product Formulation) |
The proposed regulatory amendment is to require the submission of complete qualitative and quantitative formulation data, including a list of all non-medicinal ingredients (NMIs) in a drug product, as well as the source of any human or animal derived NMIs or medicinal ingredients in products currently regulated under Division 1 of the Regulations. This information would also be required to be submitted whenever there are updates or changes to the formulation. |
| Food and Drug Regulations (Non-Medicinal Ingredient Labelling) |
The proposed regulatory amendment to Division 1 is to require the labelling of non-medicinal ingredients on the labels of non-prescription drugs for human use (with some exceptions). This may result in a positive impact on consumer health and safety, by allowing individuals to avoid life-threatening allergens and agents for which they have a history of adverse reactions. Furthermore, this would enable consumers to make informed choices when purchasing non-prescription medications. |
| Medical Devices Regulations (Investigational Testing) | The proposed amendment to the Medical Devices Regulations will further address risks to health associated with investigational testing by requiring conformance to Good Clinical Practices, reporting to Health Canada for reviewing/monitoring, and introducing an inspection program. |
| Medical Devices Regulations (Amendment to Schedule 2) |
With the addition of breast implants to Schedule 2, manufacturers of breast implants will be required to comply with the Implant Registration requirements. This will enable manufacturers of breast implants to notify implant recipients of any new information concerning the safety, effectiveness or performance of the breast implant, and any corrective action that is required to address any problems associated with the breast implant. |
| Natural Health Products Regulations/Medical Devices Regulations / Food and Drug Regulations (Schedule A Revision and Claims) |
The proposed amendment allows industry to label and advertise Schedule A preventative claims approved by Health Canada for non-prescription drugs and Natural Health Products, and the Modernization of Schedule A list of disorders and diseases. |
| Food and Drug Regulations (Clinical Trial Registration) |
Registration and disclosure of clinical trial information, including results, would provide the public with access to information about ongoing, completed and published clinical trials. Public access to such information would further good research practices, assist in making treatment decisions, and help increase public trust in clinical research. |
| Fees in Respect of Medical Devices Regulations/Authority to Sell Drugs Fees Regulations/ Drug Evaluation Fees Regulations/ Establishment Licensing Fees Regulations (Cost Recovery Initiative) |
The Health Products and Food Branch (HPFB) Cost Recovery Initiative (CRI) was established to analyze and improve upon the current cost-recovery regime that covers the regulation, licensing, compliance, enforcement, and post market surveillance of health products by providing a long-term stable funding source for HPFB. The current focus of the CRI is on human drugs and medical devices. Four (4) sets of current fee regulations will be revised in 2008-09 to reflect the revised fees as developed by the CRI. |
| Food and Drug Regulations (Regulations amending the Special Access Program) |
The regulations provide for emergency access to drugs that do not have a Canadian market authorization on a patient-by-patient basis. Amendments to the regulations will allow for the block release of such drugs to a population and/or for drug stockpiling to address public health emergencies. |
| Food and Drug Regulations (Revisions to Division 12 - Pre-packaged Water and Ice) |
The proposed amendment provides for revision and updating of the safety and labeling requirements for prepackaged water and ice products. |
| Food and Drug Regulations (Amendments to Division 3 with respect to Positron Emitting Radiopharmaceuticals) |
Amendment of Division 3, Part C of the Food and Drug Regulations with respect to the use of positron-emitting radiopharmaceuticals (PERs) in basic clinical research, in recognition that the application of the current regulations for clinical trials under Division 5, Part C of the FDR to PERs basic clinical research studies is placing an undue regulatory burden on the researchers in this field and may be impeding basic clinical research involving PERs in Canada. |
| Food and Drug Regulations (Safety of Blood and Blood Components Regulations) |
Replacement of current requirements governing human blood and blood components in the Food and Drug Regulations with new comprehensive safety and quality of blood and blood components regulations. The objectives of the new regulations include outlining clear and intelligible requirements; allowing for timely updating of the requirements as new technologies/products/issues emerge; and achieving greater harmonization in Canada related to the collection, handling and post-approval surveillance of blood and blood components. |
| Food and Drug Regulations (Amendment to C.01.016 to require notification of results of annual summary reports) |
Manufacturers will be required to inform the Minister of significant safety issues arising from their annual assessment of Adverse Drug Reaction Reports. |
| Amendment to Division 8 of the Food and Drug Regulations and Guideline to fully implement International Conference on Harmonization (ICH) E2C Guideline on Drug Safety Reporting i.e. Periodic Safety Update Reporting | Canadian requirements for periodic reporting of drug safety will be harmonized with other leading international regulators (US Food and Drug Administration (FDA), European Agency for the Evaluation of Medicinal Products (EMEA), Japan, etc.) |
| Amendments to the Natural Health Products Regulations, the Food and Drug Regulations and the Establishment Licensing Fees Regulations | The proposed dual licensing regulatory amendment will alleviate the exporting challenges arising from the coming into force of the Natural Health Products Regulations (NHPR). It will allow, on a voluntary basis, natural health product companies to hold an establishment license pursuant to the Food and Drug Regulations, in addition to the required site license under the NHPR. |
| Natural Health Products Regulations (Natural Health Products Regulatory Review) |
The Natural Health Products Directorate launched a review of the Natural Health Products Regulations (NHPR) in consideration of the challenges and issues identified in the first three years of regulating natural health products. Potential amendments which have been identified for the NHPR relate to the development of a new risk-based approach for product and site licensing, surveillance and compliance and enforcement activities. |
| Food and Drug Regulations (Extraordinary Use of New Drug Regulations) |
Under the Food and Drug Regulations, a drug is approved only if substantial evidence of its efficacy is available. Amendment of the Food and Drug Regulations will allow the approval of certain drugs the efficacy of which cannot be tested on humans in clinical trials for ethical reasons. These drugs may be required in emergency situations such as the treatment of pandemic influenza virus. The availability of these drugs is necessary to meet emergency preparedness measures which require the stockpiling of some of these drugs. |
| Food and Drug Regulations (Amendments to Division 15 Maximum Residue Limits for Veterinary Drugs) |
New or revised Maximum Residue Limits for veterinary drugs in foods to ensure the safety and quality of food products derived from treated food-producing animals. |
| Food and Drug Regulations (Prohibition of Importation for Personal Use) |
This proposed amendment will further restrict the importation of 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. These regulatory amendments will better address the health risks to human and animal health and the safety of Canada's food supply associated with the use of unauthorized veterinary drugs. |
| Program Activity: Substance Use and Abuse | |
| Marihuana Medical Access Regulations (Phase III amendments) | These amendments will address a series of issues raised by both external stakeholders and those involved in administering the Marihuana Medical Access Program, e.g., the proposed modifications would strengthen the tools available for use in ensuring compliance. |
| Promotion of Tobacco Products and Accessories Regulations (Display and Signs at Retail) (Preparation of Proposed Regulations to Restrict the Display of Tobacco Products, Accessories and Signs at Retail) |
The proposed regulations are to reduce visibility of tobacco promotion at retail. Achievements will be measured through surveys at retail. |
| Tobacco Products Information Regulations (Preparation of Amendments to the Tobacco Products Information Regulations) |
The amendment is to provide clarification and update of the applicable requirements of the regulations, correction of minor grammatical errors, redundancies and ambiguities and discrepancies between the English and French version and to remove the obligation to list numerical values for toxic emissions. |
| Promotion of Tobacco Products and Accessories Regulations (Prohibited Terms) |
The proposed regulations are to prohibit the promotion of tobacco products and accessories which display the terms "light" or "mild". The purpose is to reduce confusion among smokers regarding these descriptors. Greater awareness that no class of cigarettes is a "safer" alternative. Achievements will be measured through surveys. |
| Tobacco Products Information Regulations (Renewal of Tobacco Product Labelling Regulations) |
The proposed regulations are to increase awareness of tobacco-related hazards through mandating of new health-related information on tobacco product labels. Awareness will be measured through surveys. |
| Warnings on Advertisements Regulations | The proposed regulations are to ensure that all Canadians, particularly youth and adult non-smokers, are provided with appropriate information when they see or read tobacco advertisements, which would include messages about the health hazards associated with tobacco use. |
| Regulations Amending the Tobacco Reporting Regulations | The proposed amendments to the Tobacco Reporting Regulations are to provide clarification and update the applicable requirements of the regulations, including prescribed laboratory methods, correction of minor grammatical errors, redundancies and ambiguities in regulation and discrepancies between the English and French versions. |
| Narcotic Control Regulations (Inclusion of tramadol in Schedule I to the Controlled Drugs and Substances Act and in the Schedule of the Narcotic Control Regulations) |
Tramadol would be regulated in the same way as other opioid analgesics, thereby decreasing the potential for it to be misused while also ensuring availability to health professionals for use in treating their patients. |
| New Classes of Practitioners Regulations | The proposed regulation is to increase flexibility in the health care system by allowing midwives, nurse practitioners and doctors of podiatric medicine to conduct certain activities, such as prescribing, with controlled substances in the treatment of their patients, when authorized to do so in their scopes of practice, as determined by individual provincial/ territorial Ministries of Health. Currently, the only health professionals who are authorized to prescribe controlled substances under the Controlled Drugs and Substances Act are doctors, dentists and doctors of veterinary medicine. |
| Program Activity: Consumer Products | |
| Cribs and Cradles Regulations (Amending Cribs, Cradles and Bassinets Regulations) |
The proposed amendment is to reduce risks of injury to children posed by cribs, cradles and bassinets. |
| Corded Window Coverings Regulations | The proposed regulation is to reduce risks to children's health (strangulation) posed by cords on window covering products such as mini-blinds and curtains. |
| Regulations on Consumer Products Containing Lead (Group 1): products intended to be or likely to be placed in the mouth | The proposed regulations are to reduce health risks to children related to lead exposure. Examples include toys intended for children under 3 years of age and mouthpieces used in sports equipment and musical instruments. Performance will be based on the removal of such hazardous products from the Canadian marketplace and the level of public awareness. |
| Regulations on Consumer Products Containing Lead (Group 2): products intended for use by a child or by an adult caring for a child | The proposed regulations are to reduce health risks to children related to lead exposure. Examples include play equipment, strollers and children's clothing and accessories. Performance will be based on the removal of such hazardous products from the Canadian marketplace and the level of public awareness. |
| Prohibition of di(2-ethyhexyl) phthalate (DEHP) (Prohibition of di(2-ethylhexyl) phthalate (DEHP) from products used by children under 3 years) |
The proposed regulations are to reduce health risks to young children from exposure to di(2-ethylhexyl) phthalate in products made of soft vinyl plastics. These types of products are likely to be mouthed by children under 3 years of age. |
| Program Activity: Pesticide Regulation | |
| Pest Control Products Regulations (The amendment to the Pest Control Products Regulations is to reflect the Grower Requested Own-use Import Program under the Pest Control Products Act) |
A grower-requested own use import program in place for price discipline for pesticides available in Canada. |
| Pest Control Products Regulations Regulations pertaining to Material Safety Data Sheets for pesticides under the Pest Control Products Act |
Requirements in place for registrants to provide pesticide Material Safety Data Sheets to workplaces. |
