IMDRF has published its 2026 Document Implementation Report, providing the self-identified implementation status of IMDRF technical documents across member jurisdictions.

IMDRF releases its 2026 Playbook for Medical Device Regulatory Reliance Programs, outlining work-sharing, recognition and abridged pathways.

The FDA's new M11 technical specification, developed within the framework of ICH, defines a structured and harmonized electronic template for clinical protocols - CeSHarP. This document promotes the international standardization of clinical trial documentation, facilitating electronic submission and regulatory interoperability between agencies such as the FDA, EMA and PMDA.