Regulatory Highlights: Winter 2023

17 January 2023

Clinical Trials BC Chronicle Winter 2023 – by Jean Smart, regulatory affairs & quality officer, Clinical Trials BC

 

Consultation has re-opened for the proposed agile regulations and guidance for licensing drugs and medical devices in Canada

Health Canada has posted a notice on a proposed series of newly developed targeted regulatory amendments and provisions to both the Food and Drug Regulations and Medical Device Regulations as part of the regulatory modernization agenda. The new proposed regulations are intended to smooth regulatory processes and clear pathways to innovation. Health Canada is seeking input on seventeen (17) proposed regulations and guidances from December 17, 2022 to March 27, 2023.

There is a focus on regulatory innovation and biomanufacturing lifescience strategies. Health Canada would like to hear again from a wide variety of stakeholders including academics, consumer and patient safety organizations, drug and medical device industry, health system partners and the general public.

A summary of the key areas of input are:

  • Using terms and conditions on drug approvals and broadening their scope for Class II, III and IV medical devices
  • Repealing requirements for labelling of the standard for specific drugs
  • Allowing rolling reviews of certain drug submissions, including drugs that address a public health emergency
  • Clarifying the authority to consider information obtained outside of a new drug submission to support Health Canada’s examination of that submission for a new drug
  • Requiring risk management plans for higher-risk human drugs
  • Requiring manufacturers to submit disaggregated data for new and supplemental human drug submissions
  • Updating the requirements for certain drugs that claim a manufacturer’s standard
  • Repealing outdated requirements and replacing them with those that reflect current practices

If you or your organization is interested in participating in the consultation, there are three ways to participate:

  1. By sharing your ideas in the Canada Gazette Part 1 (Canada’s Official Newsletter),
  2. By commenting on specific guidances using on line forms and
  3. By emailing or writing your comments to the Policy Planning and Extenal Affairs Directorate

The links to the 17 documents and the contact information for responding are at: Consultation on proposed agile regulations and guidance for licensing drugs and medical devices – Canada.ca

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