Spring Intro 2023

23/03/2023

Drug development programme

Drug discovery •Patent registration •Non-clinical studies

Regulatory approval & Country HTA submission

EMA Regulatory submission

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

EUnetHTA Relative Effectiveness Assessment

Life cycle management; • new indications, • new formulations

The Organisation for Professionals in Regulatory Affairs

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Life cycle management

After MAH there are other opportunities where the regulatory team is involved in HTA • New indications and formulations (line extensions) usually trigger new reimbursement evaluations (sometimes for all indications/formulations) • Variations to MAH (other than indications) traditionally do not trigger new reimbursement applications

The Organisation for Professionals in Regulatory Affairs

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