Module 12 Presentations

EMA Portfolio Value Stream roadmap

Highlights from Strategic Review Meeting (Q3-2023)

Product Lifecycle Management

Electronic Submission and Review Tools:

➢ This stream focuses on the eSubmissions such as eCTD 4.0, its implementation, and the relevant portals

Status:

➢ Q1 2024 eCTD 4.0 specification and EU IG publication

➢ H2 2024 new tool available to support adoption of eCTD 4.0 in EU region

➢ Around Jun 2024 start of eCTD 4.0 CAPS Pilot and optional use

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12