Public release of clinical information

From: Health Canada

Current Status: Ongoing  public consultation on draft guidance document related to proposed changes to the Food and Drug Regulations and the Medical Device Regulations.

We are working to make clinical information about the safety and efficacy of drugs and medical devices available to the public. Information that Health Canada currently treats as confidential would be made publicly available following a final regulatory decision.

Why

Clinical information is data about the safety and efficacy of drugs or medical devices used in humans. Companies that make drugs or medical devices send this information to Health Canada to help it review products for sale in Canada.

Clinical information is submitted in clinical study reports. These reports include information on the design and results of clinical trials. A submission for a single product can include tens of thousands of pages of clinical information, including individual patient data.

Public access to clinical information will allow independent analysis that increases our understanding of the safety and efficacy of health products. This can improve patient care in Canada by:

  • helping patients and healthcare providers make better decisions about using drugs or medical devices
  • reducing research participant exposure to harm during duplicative studies
  • using analysis of existing data to advance new research

Who

We are consulting with:

  • health researchers
  • health professionals
  • patient groups
  • pharmaceutical industries
  • medical device industries

What

Health Canada invites stakeholder's comments on how it carries out this proposal, including the:

  • regulatory approach
  • scope of clinical information that would be publicly available following a final regulatory decision
  • clinical information that has ongoing commercial value and could be withheld from public release.

We are currently consulting on

  • draft guidance for the implementation of the public release of clinical information

Public consultation on draft guidance

On December 9, 2017, Health Canada published proposed draft regulations in Canada Gazette l to support the public release of clinical information in drug submissions and medical device applications. Feedback received during the public comment period, which ended February 22, 2018, will be considered in preparing the revised regulations.

On April 10, 2018, Health Canada published its draft guidance for the implementation of the public release of clinical information to assist stakeholders in understanding how Health Canada intends to operationalize the regulations.

The draft guidance will be open for public comments for a 75-day period (closing June 25, 2018). When preparing your comments, please indicate the relevant section(s) and line numbers (in PDF version) to which your comments relate. Comments can be sent by email to: hc.rmod.stakeholders-intervenants.dgro.sc@canada.ca.

Technical consultations on clinical information release

The draft guidance was informed by stakeholder consultations, focused on technical issues pertaining to operationalization of the public release of clinical information. Through responses to our public call letter we compiled a roster of experts and established a stakeholder reference group with expertise in:

  • data protection and privacy law
  • health data science and statistics
  • open data and end-user experience
  • clinical trial reporting, medical writing
  • anonymization and de-identification methods
  • regulatory affairs and common technical document (CTD) structure

This group is comprised of a balanced representation of interested stakeholders. Advice and recommendations from this group focuses on technical aspects of implementing of the public release of clinical information, which will inform guidance for both producers and prospective users. Health Canada met with this group regularly from October 2017 until April 2018. Information on these meetings will be published regularly.

When and where

Feedback on the public consultation on the draft guidance will be collected between April 10, 2018 and June 25, 2018.

How to participate

Read our draft changes to the Food and Drugs Regulations and Medical Devices Regulations.

Read our draft guidance to inform the implementation of the proposed changes to the Food and Drug Regulations and Medical Devices Regulations and provide your comments by email to: hc.rmod.stakeholders-intervenants.dgro.sc@canada.ca

To learn more about our prior consultations you may read our white paper, a list of submissions that are available on request, and our What We Heard report.

For further information on stakeholder engagement, both past and ongoing, you may also view a list of meetings for which documents are available on request.

Related information

Contact us

Mailing address

Office of Information Management
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Graham Spry Building
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

Telephone:
613-960-4687
Email:
hc.rmod.stakeholders-intervenants.dgro.sc@canada.ca
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