Regulatory Transparency and Openness - 2014-2015 Activities
Health Canada is committed to being transparent and open and has launched the Regulatory Transparency and Openness Framework to show how we are delivering results. Over the years to come, we will continue to make even more information available and easily accessible.
Here you will find the Regulatory Transparency and Openness Activities planned for 2014-2015. Learn more about Health Canada’s efforts on Regulatory transparency and openness.
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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.
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. The 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.
- Drug and Health Product Register - The Drug and Health Product Register is a user-friendly web portal. It lists Health Canada-approved product information and data sets. The register also allows 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 has launched 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 Reports - Health Canada receives thousands of Consumer product safety incident reports from industry, retailers and Canadians. Health Canada is now posting a summary report by product category each quarter.
- Consumer Product Safety 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 can now 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.
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 consulted with Canadians to determine how to improve nutritional information on food labels to better understand how Canadians use food labels to make nutritious choices for themselves and for their families.
- Safety Code 6 - Health Canada consulted 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.
- Stakeholder information management system - Health Canada and the Public Health Agency of Canada have launched a single web-based platform to coordinate consultations with Canadians. This platform allows individuals and organizations to register their area of interest for future consultations.
- Tamper Resistance - Health Canada consulted 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.
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