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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!

  • 1 Ensure you have the right organisational structure, resources and capabilities
  • 2 Implement appropriate evidence generation and your clinical development plans
  • 3 Revise your EU go-to-market access strategy and roadmap

Join our EU jHTA experts at our workshop "Never Mind The B*****ks, Here's The EUjHTA Basics" at WODC in Barcelona

Sophie Schmitz

Managing Director

Darren Callanan

Global Digital Lead

Pre-conference workshop

22nd Oct: 1400-1600 CET

Click here to register

We are award winning global experts in access for orphan drugs and Cell and Gene Therapies.

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