Regulatory Reliance Pathways: Challenges And Opportunities Ahead

Jan 25 2024

• By Eliza Slawther

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International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”

Networking Concept — • Source: Shutterstock

Regulators across the globe have hailed collaboration, and in particular regulatory reliance and worksharing initiatives, as the future of drug regulation. Schemes such as Project Orbis, the ACCESS Consortium, and the UK’s new International Recognition Procedure (IRP) promise not only to improve cross-border harmonization, but also to speed up patient access to drugs in countries outside of the US and EU.

While many longstanding regulatory reliance (RR) pathways were introduced to improve access to medicines in lower-income countries, there has been...

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