The ICH M14 guideline—legally effective from March 2026—introduces a long‑needed harmonized framework for non‑interventional studies using real‑world data.
By introducing ICH M14 as a global guideline, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is taking necessary steps to improve transparency and reliability, particularly in the context of post-marketing safety surveillance and pharmacovigilance.
The following sections outline how ICH M14 changes the design of non interventional studies, clarifies expectations for data suitability, strengthens methodological rigor, and introduces new operational considerations for sponsors.