ICH guidelines

The European Medicines Agency publishes guidelines that are harmonised between Europe, Japan and the United States of America by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

ICH guidelines are provided for:

• Efficacy
• Multidisciplinary
• Quality
• Safety
• Considerations

Coding system

In November 2005, the ICH Steering Committee adopted a new coding system for ICH guidelines to make the numbering and coding more logical, more consistent and clearer:

• Revisions to an ICH guideline are shown as (R1), (R2), (R3) depending on the number of revisions.
• Annexes or addenda to guidelines are now incorporated into the core guidelines and are indicated as revisions.