Module 5 Presentations

05/07/2024

4. Getting ready for the EU Clinical Regulation -Impact considerations - Readiness considerations

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

41

CTR implementation timelines

• Expected date 31Jan2023 • No option other than

• Expected date 31Jan2025 • No option other than the CTR for all study conduct

• CTR Go Live 31Jan2022 • CTD or CTR

• OJEU Notice • Critical milestone 31Jul2021

the CTR for submissions

submissions possible but no further VHP

-6 months

T=0

+1 Year

+3 Years

CTR

CTD

CTD / CTR Transition Period 2 • CTD no longer valid • All new submissions to commence through the CT Portal

Transition Period 1

• Portal ‘go-live’ • Two co-existing regulations

• Transition completed • All CTA activities to continue through the CT portal

• Full Portal

functionality published in Official Journal

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

42