CRED ERP 25

02/07/2025

What is global regulatory strategy?

Plan for developing a product to obtain and/or maintain regulatory approvals in desired global markets

What

Desired aspects

1) Achieve and maintain approvals efficiently, effectively (and ethically?)

2) Be competitive, commercially enabling and sustainable

3) Align development, business and regulatory objectives

4) Be implementable

The Organisation for Professionals in Regulatory Affairs

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What it means in practice

• Competitive, differentiated, commercially successful/(viable?) label

• Meets an unmet medical need or is better than existing treatments

• Evidence of clinical benefit and value

• Key risks identified and mitigated

• Optimised and scaled-up manufacturing process is comparable

• Secure resilient supply chain (orphan)

• Patient (long-term) follow-up (where applicable)

• Post-approval commitments / obligations

The Organisation for Professionals in Regulatory Affairs

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