Module 5 Presentations

05/07/2024

Transition planning: Based on portfolio assessment

• Studies to remain under CTD

Submitted under CTD either before Jan2022 or during transition period 1 (Jan22 Jan2023) AND finishing before end Transition 2 (global end of trial date before 31Jan2025) • Studies to transition under CTR Submitted under CTD either before Jan2022 or during transition period 1 (Jan22 Jan2023) AND not finishing before end Transition 2 (last patient last visit / global end of trial date ater 31Jan2025) • CTR studies

Early adopter studies (candidates for CTR submission in Transition period 1) All studies from 31Jan2023 (no further options to submit under CTD)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

55

CTR: Take Home messages

Entry into force • EU CT Regulation to replace the existing EU CT Directive • Regulates interventional clinical trials with medicinal products for humans, conducted in 1 or more EU member states (EU / EEA) • Only once Portal and Database readiness have been officially confirmed by EU Commission via audit (now expected mid 2021) • Transition periods: 1 year for submissions / 3 years for ongoing CTs • VHP will stop at entry into force • Use of CTR from day 1 of transition will be strongly impacted by Clinical Trial Information System (CTIS) functionalities Key attributes • Single EMA portal for Competent Authorities (CA) and Ethics Committees (EC) • Greater results transparency (lay language CSR, IB, Protocol, etc.): public access via CTIS • New: EU-wide Serious Breach reporting • New: low intervention clinical trial, with less stringent reporting and monitoring (operational details and impact still TBC)

Communication and trainings will be critical (internally and with vendors)

Two trial management systems to run simultaneously, with a phased implementation

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

56