ICH guideline

ICH M2 EWG: Electronic Standards for the Transfer of Regulatory Information

ICH guideline · Multidisciplinary Guidelines

Key facts

ICH code M2 EWG
Title Electronic Standards for the Transfer of Regulatory Information
Guideline series Multidisciplinary Guidelines
ICH summary (excerpt) The M2 Expert Working Group (EWG) was established by the ICH Steering Committee in 1994 with the objective of facilitating international electronic communication by evaluating and recommending, open and non-proprietary - to the extent possible - Electronic Standards for the Transfer of Regulatory Information (ESTRI)…
File Presentation SDOs
File type PowerPoint
File on ich.org database.ich.org

At a glance

  • Yes Full text searchable in Orca1
  • Presentation SDOs Files published by ICH
  • None FDA guidance documents based on this guideline

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About ICH guidelines

ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.

Source: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline summaries are ICH material, reproduced with acknowledgement

Browse all ICH guidelines