Regulatory Transparency and Openness - 2017-2018 Activities

Health Canada is committed to being transparent and open and has launched the Regulatory Transparency and Openness Framework and Action Plan 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 Framework activities planned for 2017-2018. Learn more about Health Canada’s efforts on Regulatory Transparency and Openness.

Inform and Engage

Provide more information about the regulation of generic drugs

We play a central role in regulating thousands of products used by Canadians every day, including generic drugs. To better inform Canadians about generic drugs, we will expand upon current available information to explain the process of how these drugs are brought to market after a drug submission is received.

Provide more information about the Department's stakeholder engagement activities on key policy files

As part of our commitment to be more transparent about the work we do, we will share information with Canadians about our stakeholder correspondence and meetings related to healthy eating initiatives.

Engage Canadians in modernizing the regulation of self-care products

The Department will continue to engage consumers and stakeholders on the development of a modernized approach to the regulation of self-care products through a series of in-person and online consultation sessions.

Improve our alignment with the health care system by using a standardized approach to Drug Product Monographs

Drug Product Monographs are factual documents that contain scientific data about drug products, and are made available to the public as part of Health Canada's commitment to openness and transparency. The Department will publish the complete Structured Product Monograph with aggregated Regulatory Decision documents and Adverse Event Reports through the Drug and Health Product Register.

Provide stakeholders with up-to-date information about the activities of Health Products and Food Branch scientific advisory bodies

Health Canada will provide updated online information about the meeting activities of its Scientific Advisory Panels and Scientific Advisory Committees. This will include information about the topics these bodies discuss, when they meet, and decisions that are made at meetings.

Engage stakeholders on a proposed transparency initiative related to generic drug products

Health Canada will consult with stakeholders on a proposal to better explain how decisions are made about certain prescription generic drug products.

Enable

Share more information about the drugs and medical devices we regulate

Health Canada will introduce draft regulations and an operational plan to publicly release clinical information relating to safety and effectiveness of drugs and medical devices once decisions have been made on industry submissions.

Continue to make more scientific data and information publicly accessible

Health Canada will continue to contribute to the federal government’s Open Data initiative by providing an updated dataset inventory and new datasets on the government’s Open Data Portal.

Develop and implement policies and procedures for sharing Confidential Business Information related to therapeutic products

The Department will develop and implement a fair, consistent and effective process for Health Canada’s decision-making regarding disclosure of Confidential Business Information related to therapeutic products, and will create opportunities for stakeholder input as this work is being developed.

Enforce

Quarterly reporting on illicit drug analysis statistics and trends

The Department will provide easy to understand information from our Drug Analysis Service, including illicit drug analyses statistics and trends.

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