Spring Intro 2023

30/03/2023

When should I seek advice?

Possible at any time during drug development • Pre-Clinical Trial Applications • When we have preliminary data to strengthen rationale • End of Phase 2 • Can seek multiple rounds of scientific advice

Should be coordinated with advice sought in other regions

Strongly consider advice at least after Phase 2 - prior to Phase 3 initiation

Top tip – In many instances, US advice precedes EU advice. Ensure EU advice is discussed early enough to ensure outcome around same time as US advice

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How?

4 Main Routes

• EMA (Centralised) Scientific Advice – Pan-European Advice by EMA’s Scientific Advice Working Party – Advice endorsed by CHMP

• National Scientific Advice with individual national regulatory agencies

• Parallel/Joint Scientific Advice EMA/FDA*

• Regulatory/Health Technology Assessment (HTA) joint advice – Includes seeking cost-effectiveness advice with Reimbursement Agencies

*https://www.ema.europa.eu/en/documents/other/general-principles-european-medicines-agency-food-drug-administration-parallel-scientific-advice_en.pdf

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