Pangaea Express: PMPRB Guideline Reform Update
The PMPRB released its quarterly Newsletter Volume 22, Issue 4 that contained an update on the Guideline Reform. The PMPRB has been holding targeted consultations with stakeholders through the Steering Committee for Guideline modernization and the technical working group. The two groups have met multiple times, however due to the complexity and conflicting views, the progress has been slower than anticipated. Both groups are required to produce a report prior to the release of the new draft Guidelines which is slated to coincide with Health Canada’s publication of the final regulatory amendments.
The January 2019 implementation date is now unlikely and the PMPRB is revising the schedules for the Steering Committee and the Working group accordingly. The status of the work will continue to be made available on the PMPRB website.
As a result of the delay, the PMPRB have released an additional 2019 HDAP meeting date of May 27, 2019.
In addition to the update on the Guideline progress the quarterly newsletter contained:
- NPDUIS update: Engagement activities
- New and upcoming publications
- 2019 CPI-Based Price-Adjustment Factors for Patented Medicines
- Summary of the Board’s October 2018 Meeting
While there is no further information on the content of the guidelines or regulations, we do know that business will continue under the current guidelines into the beginning of 2019.
For more information or questions, please contact Suzanne Solman.