Definition

MedDRA is released twice yearly (March, September). MAHs must plan upgrades and map legacy data; coding consistency affects signal detection.

Example

Upgrading to MedDRA 27.0 and documenting impact on running analyses.

Regulatory source

MedDRA MSSO, GVP Module VI

Common mistakes

Delaying upgrade and creating version inconsistencies across regions.

Inspector question

How do you manage MedDRA versioning and impact on case coding?

Related terms