CRED ERP 25

01/07/2025

Other Key Strategic Considerations UK

Similar to EU

Different to EU • Innovative Licensing and Access Pathway (ILAP) • Bridging the P3 to launch gap with early access • Promising Innovative Medicines designation (PIM) • Early Access to Medicines Scheme (EAMS) • Project Optimus / Access Consortium

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• Orphan drug considerations

• Paediatric investigation plans (PIPs)

• Scientific advice

The Organisation for Professionals in Regulatory Affairs

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SUMMARY

The Organisation for Professionals in Regulatory Affairs

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