Module 12 Presentations

EMA Portfolio Value Stream roadmap

Highlights from Strategic Review Meeting (Q3-2023)

Product Lifecycle Management

Regulatory Procedure Management (RPM) for Product Lifecycle Management :

➢ EMA’s product lifecycle management goal is to have all regulatory procedures for product lifecycle management in one single IRIS portal

➢ The IRIS portal is only for products under EMA managed procedures ( CAPs )

➢ The IRIS portal is linked to SPOR data to enable data re-use and increase data quality

➢ EMA is increasingly onboarding regulatory procedures management activities to IRIS portal:

➢ Q1 2024 (23 Jan 2024) roll-out for variations, MA transfers and Art 61(3) for subset of products (mainly generics)

➢ Followed in H2 2024 → Jan 2025 roll-out for additional products and procedures

➢ The portal will be used to submit working documents to the EMA and EU Network (for communication), however the submission process via the Gateway remains unchanged New date

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12