PMPRB has released its May 2018 NEWSletter which includes anticipated updates on PMPRB’s timelines for its Guidelines modernization initiative:

• June 2018:
  • PMPRB to release more specific guidance on how the PMPRB foresees operationalizing regulatory changes
  • PMPRB to form a multi-stakeholder Working Group to gather input on key technical aspects of the new approach
• Fall 2018:
  • Working Group’s report to be presented to the Board for consideration
  • Draft guidelines to be published
  • Consultation period on draft guidelines

PMPRB plans to finalize its Guidelines after gazetting of the amendments to accommodate any changes which would impact the approach laid out in the draft guidelines.

PMPRB had previously stated in its March 2018 NEWSletter that draft guidelines could be anticipated in Spring 2018. Given the delay to Fall 2018, it is unlikely that changes will be effective in January 2019 as originally planned.

Other updates from the May 2018 NEWSletter include:

• Voluntary Compliance Undertakings have been approved concerning
  • Metoject Subcutaneous (methotrexate sodium)
  • Onreltea (brimonidine gel)
  • Vectibix (panitumumab)
• Board’s April 2018 meeting included debrief on regulatory framework modernization & forthcoming guidelines consultations, as well as the 2017 PMPRB Annual Report

For more information, please see the PMPRB May 2018 NEWSletter