Consideration documents are documents developed by discussion groups i.e., Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group. These documents reporting specific scientific considerations do not require the formal ICH approval procedure (sign-off), but do require discussion and endorsement by the ICH Steering Committee.

Gene Therapy Discussion Group

In September 2002 the ICH Steering Committee established a Gene Therapy Discussion Group (GTDG) in recognition of the rapidly evolving area of gene therapy medicinal products. The GTDG developed several ICH Consideration documents in the area of gene therapy which can be found below. In September 2011, after extensive SC discussion that currently the ICH regions do not have the resources to support the development of further ICH consideration documents, the development of these considerations papers was discontinued.