International Reliance and Work-Sharing Programs: Speeding up Access to Medicines

A high unmet medical need persists for certain diseases due to the absence of treatments or treatments not adequately addressing the disease/condition. International reliance and work-sharing programs can support streamlined, more efficient development and assessment of new treatments for several markets. Additionally, these programs can reduce the workload for individual regulators and result in aligned regulatory assessment.

The key benefit of these programs is the potentially accelerated assessment of a medicine and decision alignment by multiple regulators through reliance on the work of other trusted authorities. The ability of sponsors to submit the same or very similar application package to multiple regulators and competence of regulators to rely on assessments by other regulators reduces duplication and increases efficiency in assessment potentially speeding up access to safe medicines. Examples include, Project Orbis (concurrent submission and assessment of oncology products among participating partners such as Health Canada, ANVISA for Brazil, Swissmedic), the Access Consortium (a coalition of mid-sized regulators such as Health Canada, Swissmedic, the Australian Therapeutic Goods Administration [TGA]) and the U.K.’s International Reliance Procedure (potential reliance on a regulatory decision from trusted regulators such as the TGA, Health Canada, US FDA and European regulators).

The session will begin with a brief overview of these programs, their applicability to development programs, timelines and the participating regulators. Industry experts and regulators will provide their experience with participating in these programs. What challenges were encounter? What was the biggest benefit from participation? Where did the outcomes align or diverge between participating regulators and why?