Director of the Bureau of Metabolism, Oncology and Reproductive Sciences, Therapeutic Products Directorate Health Canada
Historically, most major global regulators have undertaken a de-novo comprehensive evaluation of pharmaceutical applications regardless of whether they have been reviewed and approved elsewhere, leading to duplication of effort and delays to patient access. But what if regulators could share the workload or collaborate on the review and approval of a product with other health authorities?
During this presentation we will outline recent programs and pilots which expedite the evaluation activities and timelines through the recognition of product evaluations and approvals by comparable international regulators. Case studies will be discussed on the utilization of this approach by the ACSS Consortium and the FDA’s Project Orbis in the US, Canada, Australia, Singapore and Switzerland. Health Authorities from the ACSS and Orbis regions will provide commentary on these pathways and tips for those planning to participate in these novel work arrangements.
Identify pathways that can be utilised to expedite regulatory approval by leveraging approval in comparable jurisdictions.
Identify opportunities to achieve a simultaneous regulatory approval in multiple territories through shared and parallel evaluations.
Explain how to leverage a regulatory approval to accelerate market access in the Asia-Pacific region.