Regulatory transparency and openness
The Government of Canada is making more data and information available to Canadians than ever before. Canadians are also being offered more opportunities to participate in discussions on government policies and priorities
As a regulator, Health Canada plays an important role in protecting the health and safety of Canadians. Greater transparency and openness with Canadians strengthens the trust in our regulatory decisions.
The Regulatory Transparency and Openness Framework for Health Canada supports our commitment to the Government's overall Open Government initiative. This will ultimately support Canadians in making better decisions about their health.
Here you will find
What is transparency and openness?
Transparency is making relevant, timely and useful information available to the public in easy to access formats.
Openness is inviting, hearing, considering and sharing information with the public as Health Canada makes its regulatory decisions.
Health Canada's vision
Health Canada is committed to transparency and openness. As a trusted source of credible and timely information, we can help Canadians take action on their health and safety.
Why is regulatory transparency and openness important?
Health Canada makes health and safety decisions about products that Canadians buy and use every day such as:
- medical devices, like pace makers
- natural health products
- consumer products, like children's toys
- radiation emitting devices
- cosmetics and pesticides
Science and technology are constantly changing how these products are made and sold to Canadians. Hundreds of new products, with new ingredients and new purposes, are introduced every year in Canada. This means that the number of regulatory decisions made by Health Canada each year can number in the thousands.
Canadians trust Health Canada to make regulatory decisions based on valid evidence. The credible, timely information we provide allows them to make informed choices for themselves and their families. Health Canada's decisions impact the day-to-day lives of Canadians. We know they want to understand how and why we make our decisions. Moreover, they want to feel meaningfully involved in and consulted within the decision-making processes.
The number of alternative health and safety information sources that Canadians consult is rapidly growing. This information is of varying scientific quality and accuracy. The Regulatory Transparency and Openness Framework aims to address this reality head on.
Moving forward, every year we will list the actions we will undertake to enhance regulatory transparency and openness. And every year we will report on what has been achieved.
Canadians will have a better understanding of how and why our decisions are made. They can use this information to make well-informed decisions on their health and the health of their families. Ultimately, Canadians will continue to trust Health Canada as a reliable and credible source of health information.
Transparency and openness principles to live by
- Regulatory decisions will be developed with an expectation that they may be made available to Canadians proactively.
- Summaries of key regulatory decisions and actions that impact Canadians will be made available to the public in a timely manner.
- Information for the public will be available in plain language, detailing how and why a decision was made while protecting confidential business information and respecting legislative responsibilities, including privacy and official languages.
- The Department will continue to look for ways to engage Canadians as it undertakes regulatory decision-making processes and to share the results of its consultations.
What we are already doing
Health Canada is open and transparent in the way it does business. Here are several Health Canada initiatives that keep Canadians well-informed and allow them to protect their health and the health of their families.
Credible and timely information
Healthy Canadians gives Canadians important health and safety information written in plain language. The website provides information on quitting smoking, healthy eating, recalls and safety alerts, and much more. Health Canada also uses social media channels like Facebook, Twitter, Pinterest, YouTube, and blogging to provide accurate, up-to-date information to Canadians. Currently, more than five million Canadians have visited our online and social media presence.
Canadians also have access to Health Canada databases. Here is a sample.
- Recalls and Safety Alerts Databaseá- provides Canadians with information about the possible risks associated with consumer, health and food products. The database provides credible timely recalls and alerts about all kinds of products from toys to weight-loss products.
- Canada Vigilance Database - provides information on adverse reactions to approved health products.
- Pesticide Product Information Database - gives Canadians information on specific products, active ingredients or programs related to pesticides that are regulated by Health Canada.
Open Government Initiative
Health Canada has embraced the Government of Canada's Open Government Initiative. We post datasets on the Open Data portal. This site provides free government data for re-use by governments, citizens, voluntary organizations, academia, and the private sector.á We have also made significant progress in activities related to Open Regulation.á We post information such as Forward Regulatory Plans and Service Standards for High-Volume Regulatory Authorizations so as to make the regulatory system clearer and more predictable for Canadians and businesses.
Public consultation and engagement
Health Canada frequently consults and engages with Canadians on regulatory changes, acceptable exposure limits to chemical substances and food additives, and updates to industry guidance.
Canadians are invited to comment on regulatory changes through the:
How we will continue to improve
Health Canada will step-by-step make information and regulatory decision-making processes more transparent and open to Canadians.á There are three main goals to be achieved moving forward. For each of these goals we have outlined concrete actions to be achieved this year. As they are implemented over the course of the year, the links below will go live.
1. Making information easier to understand
Health Canada's regulatory decisions are science-based. To ensure Canadians understand the regulatory decisions and their impact, Health Canada will present information to Canadians in plain language in easy-to-navigate formats.
- Consumer-friendly nutrition information and tools - Health Canada has developed online tools and information to help Canadians make safe and nutritious food choices. As these tools are updated or new tools are added, the information will be updated.
- Health product labels (Plain language labelling initiative) - Health Canada requires plain language on drug packages and product labels. This is to protect Canadians from adverse drug reactions and medication errors. The plain language labelling initiative will ensure health product labels and packages are clear, accurate and easy to understand.
- Consumer product safety (Risk assessment framework) - The Canada Consumer Product Safety Act and the Food and Drugs Act protects Canadians from unsafe consumer products and cosmetics. Health Canada will release a Consumer product safety-risk assessment framework that explains how we conduct risk assessments for consumer products and cosmetics.
2. Making more information available
To ensure that Canadians have access to the information they need and are interested in, Health Canada will develop more health and safety information which can be shared proactively with the public.
- Drugs and medical devices - Health Canada authorizes drugs and medical devices for sale in Canada. To help Canadians understand the scientific facts and risks involved in their approval, Health Canada produces the document: Summary basis of decision. These documents explain why Health Canada authorized certain drugs and medical devices for sale in Canada.
- Health Canada works collaboratively with provinces and territories, as well as industry stakeholders and health care practitioners to address drug shortages and to build a more open and secure drug supply system.
- Clinical drug trials - Canadians have access to the Health Canada centralised database. The database provides accurate and timely information about authorized Canadian clinical drug trials.
- Biannual Chemicals Management Plan Progress Reports - Under the Chemicals Management Plan, Health Canada and Environment Canada work together to protect Canadians and the environment from harmful chemicals. Progress Reports on the Plan are posted twice a year on the Government of Canada's Chemicals Substances website.
- Assessment Summaries for New Chemical Substances - Health Canada and Environment Canada assess substances new to Canada for health and environmental risks before they can be manufactured or imported. Assessment summaries are now posted on the Government of Canada's Chemicals Management website when conditions or other requirements are placed on new substances.
- Inspection summary reports - Health Canada is making available to Canadians annual reports that summarize the results of inspections it has undertaken. áThe summary report includes statistics on risk observations and compliance ratings.
- All health products made in Canada must meet high standards for safety and quality before they can be sold to Canadians. Inspections for Good Manufacturing Practices (GMP) are an important part of making sure that these standards are being met.
- Health products register - The Health products register will be a user-friendly web portal. It will list Health Canada-approved product information and data sets. The register will also allow Canadians to give feedback on product safety and effectiveness.
- Drug safety reviews - Health Canada has begun to post summaries of drug safety reviews. These reviews provide information on approved drugs that both Canadians and medical professionals can use to make informed decisions.
- Scientific assessments of novel foods (online summaries) - Novel foods are foods that have been produced through new processes. All novel foods must be assessed by Health Canada for safety before they can be sold in Canada. These include food:
Health Canada is launching a pilot project to begin posting the assessment summaries for approved novel foods.
- with no history of safe use
- modified by genetic manipulation
- Consumer product safety incident (summary reports) - Health Canada receives thousands of Consumer product safety incident reports from industry, retailers and Canadians. Health Canada will post a summary report by product category each quarter.
- Consumer product enforcement (summary reports) - Health Canada regularly inspects and tests consumer products, (like children's toys and jewelry) to ensure they meet the necessary safety requirements. Canadians will be able to access inspection reports that show which products do not meet safety standards. The summary reports also show what industry is doing to correct the problems.
3. Making the decision-making process more open
Health Canada will seek opportunities to invite, hear and consider diverse points of views in the decision-making process. This includes dialogue and engagement with experts, regulated parties and consumers. In keeping with the commitment to transparency, Health Canada will report on the public input received and detail how the decision was made.
- Food Labelling - Health Canada is consulting with Canadians to determine how to improve nutritional information on food labels. We want to better understand how Canadians use food labels to make nutritious choices for themselves and for their families.
- Safety Code 6 - Health Canada is consulting Canadians on a revised version of Safety Code 6. This Safety Code is Health Canada's guideline for recommended human exposure limits to radiofrequency electromagnetic energy. It is posted on Health Canada's website and is open for comment until July 15, 2014.
- Stakeholder information management system - Health Canada and the Public Health Agency of Canada will launch a single web-based platform to coordinate consultations with Canadians. This platform will allow individuals and organizations to register their area of interest for future consultations.
- Tamper Resistance - Health Canada is consulting with Canadians on proposed regulations that would require drugs at high risk for abuse, like controlled-release oxycodone, have tamper-resistant properties before they can be sold in Canada. It is posted on Health Canada's website and is open for comment until August 28, 2014.
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