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Project Orbis Led To 80% Cut In Submission Gap For Cancer Drugs In Switzerland

 
• By Eliza Slawther

The international Project Orbis regulatory collaboration initiative reduced the submission gap between filings made in the US and Switzerland even more than expected, marking a step towards faster access to innovative cancer drugs, regulatory experts have told the Pink Sheet.

Medical pills and flag of Switzerland
• Source: Shutterstock

The Project Orbis initiative, which provides a framework for international partner regulators to evaluate cancer drug filings concurrently or near-concurrently with the US Food and Drug Administration, led to a 135 day reduction in the regulatory submission gap in Switzerland, according to a study published in The Lancet .

The median submission gap was 33 days for oncology marketing authorization applications (MAAs) made to Swissmedic, Switzerland’s drug regulator, through the Project Orbis pathway,

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