Time remaining

&nbsp

IMPLEMENTATION DATE
12th January 2025

Are you prepared for the inevitable?

From 2025, it will be mandatory for all newly launched ATMPs and oncology medicines to undergo a joint clinical assessment (JCA) at the European level

What does this mean for your launch strategies?

Key milestones

2022
The first step

EU HTA Regulation was adopted

2022 - 25
Preparation work

Development of procedures for joint clinical assessment & joint scientific consultations

2025
Rules changes

All newly approved and oncology ATMPs medicines to undergo EU level joint clinical assessment

2028
OD inclusion

Regulation extended to all newly approved orphan products

2030
All therapies

Regulation extended to all therapies centrally approved by EMA

The time to act is NOW!

Join our EU HTA experts at our free quarterly drop in clinic to discuss in more detail

Akshay Kumar

Partner

Chloe Sheppard

Consultant

Linkedin live event

17th May: 1300-1500 UK