Worksharing with other international regulatory authorities

This project will create a streamlined process for joint reviews between Health Canada and other international regulatory authorities.

It will build on our existing relationships with the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. Lessons learned in this worksharing arrangement will help to develop a worksharing framework. This may expand to other national regulatory authorities interested in partnering.

We expect this project to strengthen our partnerships. Partnering in submission reviews will help Canadians gain greater access to new health products that meet health care system needs. This includes drugs for rare diseases.

The tasks for this project include:

• Notice to Industry: Expression of Interest in Joint Reviews (winter 2017-18)
• pilot worksharing arrangements (April 2018 to April 2019)
• consultations with stakeholders (2019 to 2020)
• implementation plan (2020)

We expect that all parts of this project will be fully in place by fall 2020.