CRED ERP 25

01/07/2025

Probability of success

Centralised • “ All or nothing ” but majority decision when consensus not reached Decentralised • Choose RMS and CMS but can no longer withdraw in stage 2 to avoid arbitration/referral • No consensus = referral

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The Organisation for Professionals in Regulatory Affairs

13

Internal factors – specific to procedural choice

• How does your choice of EU procedure impact the global strategy?

• Company infrastructure/level of experience

• Effective and Robust Planning

• DCP/MRP ‘slot’ / Letter of Intent • Meetings (Scientific Advice / Pre-submission meetings / etc) • Document preparation • eCTD publishing & assessment activities

The Organisation for Professionals in Regulatory Affairs

14

7