Module 12 Presentations

IDMP implementation by other regulators

Swissmedic

MHRA (UK)

• Approach and plan now in place

• MHRA will adopt G-SRS (UK-SRS) as their substance management tool • Data provided in UK eAFs will be validated against their internal IDMP compliant systems, including UK-SRS • MHRA is aligning with SPOR, but will not be able to use those services • Q2 2024 shared as a milestone of releasing some of the services (e.g. UK-SRS), but exact details are to be still provided

• Plan is focusing on initial use case linking marketing applications eAF and reuse of EUSPOR

• Currently in IDMP pilot project

• Timeline for Swiss IG is still TBD

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12