Public release of clinical information

From: Health Canada

We are updating how we disclose the clinical information used to assess the safety and effectiveness of drugs and medical devices. This information can have widespread benefits for:

  • patients
  • the health care system

For example, giving more details about drugs and medical devices helps independent analysis. That could help health professionals make more informed decisions about appropriate use. It could also help reduce inappropriate use.

We asked for public input on a discussion paper published online, to help us consider how best to make this information more widely available.

We also asked experts for their opinion on how to put these proposed regulations into practice. These experts included:

  • academic researchers
  • industry representatives
  • health care professionals

On December 9, 2017 we published draft regulations. These specify the clinical information in drug and medical device submissions that would not be confidential business information, following a final regulatory decision. They also authorize the Minister to make the information publicly available.

The tasks for this project include:

  • Draft regulations opened for public comment for 75 days, ending February 22, 2018
  • a second phase of stakeholder and expert consultations to be completed March 31, 2018
  • a draft guidance document released for public consultation, March 2018
  • publishing final regulations

We expect that revised regulations will be in force and operating in the fall of 2018.

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