Regulating Risk: Keeping You Up-To-Date on Product Regulation - September 2016

Here’s a look at what’s new with product regulation and oversight in Canada.

Health Canada Releases Report on Regulatory Transparency and Openness

Health Canada has issued its Annual Report summarizing the steps it took in 2015-2016 to provide Canadians with tools and information to assist them in making health decisions. The report notes that Health Canada’s launch of the Drug and Health Product Inspections Database. This database provides previously unavailable information about drug manufacturing, clinical trials, medical devices, pharmacovigilance practices and cells, tissues and organs.

Planned 2016-2017 activities of note include:

  • Providing information to the public on drug shortages
  • Providing more guidance to support compliance with regulatory requirements
  • Expanding publicly available information about Health Canada’s approval decisions regarding high risk
  • Expanding and enhancing inspection reporting across a wide range of products including drugs, medical devices, marijuana for medical purposes and consumer products

The report can be accessed here.

Microbeads Designated as Toxic Substance

As of June 29, 2016 Microbeads have been added to Schedule 1, under the Canadian Environmental Protection Act 1999. Microbeads are defined as plastic microbeads that are less than or equal to 5 mm in size. It is anticipated that this designation will be followed by regulatory mechanisms to restrict or even prohibit the use of microbeads in cosmetics and other consumer products.

More information regarding the status of microbeads can be found here.