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
19
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
10
Made with FlippingBook Annual report maker