The US-led Project Orbis was initiated by the Food and Drug Administration in May 2019, with the aim of establishing a framework for international regulators to concurrently review filings for cancer drugs.
Swissmedic On Project Orbis: Faster Access To Drugs, Valuable Scientific Discussions
In the first of a two-part interview with the Pink Sheet, an expert from the Swiss drug regulator explains why international collaborations are “the future” and outlines the agency’s “extremely positive” experience since joining the Project Orbis initiative three years ago.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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