CRED 8 Presentations

03/07/2024

Strategic Considerations

Well Established Use

Critical Success Factors

• Product has been on the market for at least 10 years • Scientific Literature • Product Development

Market Segment

• Re-Branded products • New Indications (higher bar)

• PIP is NOT required • Scientific Advice is possible • CP is not possible

Regulatory

Timelines

• 1.5 – 2yrs for MA (usually national)

Development Work

• CMC

The Organisation for Professionals in Regulatory Affairs

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Strategic Considerations

Fixed Combination

• Data Exclusivity for active ingredients have elapsed • Scientific Literature to support combinations • Product Development

Critical Success Factors

Market Segment

• Improved Patient Compliance/convenience

• PIP is required • Scientific Advice is possible • Some reference to established active components

Regulatory

Timelines

• 1 – 1.5 yrs for MA (DC/MP/CP)

• Biostudy • Some safety/efficacy studies • CMC

Development Work

Misc.

Common for originator to apply a combination (e.g. GSK & Augmentin) Open to generics

The Organisation for Professionals in Regulatory Affairs

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