Spring Intro 2023

23/03/2023

Drug development programme

Drug discovery •Patent registration •Non-clinical studies

Regulatory approval & Country HTA submission

EMA Regulatory submission

Life cycle management; •new indications, •new formulations

Clinical trials •Phase 1&2 •Phase 3 Early dialogue (parallel consultation) Early Access programmes

EUnetHTA Relative Effectiveness Assessment until 2025 - 2030

The Organisation for Professionals in Regulatory Affairs

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EUnetHTA HTA Core Model ®

SCOPE

HTA Core Model DOMAINS

1. Health problem and current use of technology

2. Description and technical characteristics

3. Safety

4. Clinical effectiveness

Rapid REA

5. Costs and economic evaluation

6. Ethical analysis

EUnetHTA does not give recommendations on added value or reimbursement

7. Organisational aspects

8. Patient and social aspects

Comprehensive/ Full HTA National appraisal

9. Legal aspects

The Organisation for Professionals in Regulatory Affairs

20

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