![]() ![]() Participating countries have signified a strong commitment for continuation and growth of the program. Across the program, the median time-to-approval was similar between FDA (4.2 months, range 0.9–6.9, N = 18) and the POP (4.4 months, range 1.7–6.8, N = 20). The median time gap between FDA and Orbis submission dates was 0.6 months with a range of −0.8 to 9.0 months. New molecular entities, also known as new active substances, comprised 28% of the received marketing applications. In the first year of Project Orbis (June 2019 to June 2020), a total of 60 oncology marketing applications were received, representing 16 unique projects, and resulting in 38 approvals. While FDA serves as the primary coordinator for application selection and review, each country remains fully independent on their final regulatory decision. Project Orbis leverages the existing scientific and regulatory partnerships between the various RHA under mutual confidentiality agreements. ![]() Current Project Orbis partners (POP) include the regulatory health authorities (RHA) of Australia, Brazil, Canada, Singapore, and Switzerland. Project Orbis aims for concurrent submission, review, and regulatory action for high-impact clinically significant marketing applications among the participating partner countries. In 2019, the FDA Oncology Center of Excellence launched Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries.
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