ICH: considerations

The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Consideration documents are documents developed by discussion groups such as the Gene Therapy Discussion Group that report specific scientific considerations. They do not require the formal ICH approval procedure, but do require discussion and endorsement by the ICH Steering Committee.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.


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