Module 12 Presentations

IDMP implementation by other regulators

FDA

• Phased, global approach announced for the implementation and use of IDMP – focus on efforts in the Global IDMP Working Group (GIDWG) incl. EMA

• Aim is to advance international harmonization and framework to implement and maintain global identifiers

• FDA IDMP guidance has been published March 2023

• Yet: Technical specifications, further guidance, and timing details still TBD

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12