Module 12 Presentations

The global overview regarding regulatory data standards

EMA is leading the way with their adoption of the ISO IDMP standards but there is movement on a global scale

Published Guidance for Industry in the Federal Register on March 30, 2023 on IDMP implementation and their intentions. Their current standards already conform to 4 out of 5 ISO standards for regional use. Committed to cover all and increase global interoperability. Implementing IDMP through master data management program (SPOR). Four services / databases where data is captured / managed. Iterative approach by applying and embedding IDMP data requirements into existing regulatory processes (e.g., PLM eAF).

Implementing Emerging Preparing

Regulators Status

Planning to starting to use IDMP data for initial Marketing Authorization Application.

Communication expected on the release of IDMP compliant application forms.

Watching

Planning

Taking Action

The Organisation for Professionals in Regulatory Affairs