May 28, 2018
Following the review of more than 100 submissions and 700 comments, Health Canada has considered the divergent views of various sectors to the October 2017 fee proposal and released its revisions. Most notable of the changes is a reduction in the fee for pre-market evaluation from 90% to 75% of costs, with a phased in approach to implementation. Performance standards for Health Canada are mostly unchanged. For further details, including Health Canada’s response/rationale, and the forms for submissions can be found on the Health System and Services section of the Government of Canada, called Revised Fee Proposal for Drugs and Medical Devices. Stakeholder submissions are open until June 14th, 2018.
For more information, please contact Bev Herczegh, R.Ph., B.Sc.Phm., Director, The Pangaea Group.