Module 6

03/10/2024

From EU Regulatory Submission to Access Submission

Day 0

80

120

121

150

180

181

210

277

Submit MAA

Draft initial assessment report

Draft joint assessment report

Oral Explanation

Positive Opinion

Marketing Authorisation

Report

EMA Q’s Co.’s A’s

MAA

EPAR SPC

Label, RMP, ph IV

L- [13/15]

L-12

L-[9/11]

L- [6/8]

L-[5/7]

L-[4 /6]

L-3

L-2

L=0

Earliest Launch

Central Value Support Materials Core Economic Model

Local Dossier Development

Local Expert Consultations

Economic model Local Adaptations for submissions

Reimbursement and HTA submissions NICE ITALY SMC.

Planning for phase IV observational studies and other reimbursement commitments

33

In This presentation we covered

⚫ Demonstrating value of medicines is fundamental to commercial success ⚫ HTA processes vary but have common elements ⚫ HTA and Regulatory Authorities are different, but a beginning to look for common ground ⚫ The Regulatory Affairs role is a key partner to support the value of, and access to new medicines for all patients

34

17