CRED 8 Presentations

03/07/2024

Strategic Considerations

Informed Consent

• Comprehensive Contractual Agreement • Considered long term manufacturing program

Critical Success Factors

• Part of the ‘generic basket’ • Sponsors ‘MO’ whom provide multiple duplicate licenses • Originator wishes to ‘rebrand’ product (OTC?)

Market Segment

• PIP is NOT required • Scientific Advice is not essential • Slightly different local requirements between MS

Regulatory

Timelines

• 1yr for MA

Development Work

•N/A

•OTC • Multiple brands

Misc.

The Organisation for Professionals in Regulatory Affairs

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Strategic Considerations

Generic

• Day One Launch • Clear Patent & Data Exclusivity Pathway • Robust Product Development (full M3/reverse engineering)

Critical Success Factors

• Multiple generic players/a lot of competition • Tendering business, steep price erosion • Re-Branded products

Market Segment

• PIP is NOT required • Scientific Advice is possible, not usually required • Choice of appropriate Reference Medicinal Product is key

Regulatory

Timelines

• 1.5 – 2yrs for MA (DC/CP)

• CMC •Bioequivalence study/bioanalyticalmethod

Development Work

• CP might be available, but option to have a smaller DCP • Consider Pricing & Reimbursement for each Market

Misc.

The Organisation for Professionals in Regulatory Affairs

32

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