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 centralised HTA

From 2025 onwards

The Organisation for Professionals in Regulatory Affairs

27

New centralised HTA

The Organisation for Professionals in Regulatory Affairs

28

14