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Consideration Documents
- Work Products
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
The International Conference on Harmonisation (ICH) Steering Committee recognised that in the rapidly evolving area of gene therapy medicinal products, there is a need to continue to foster the exchange of information that may impact on the regulation of such products. The Gene Therapy Discussion Group (GTDG) is leading these activities within the ICH.
The objectives of the GTDG are :
- Monitor emerging scientific issues
- Proactively set out principles that may have a beneficial impact on harmonising regulations of gene therapy products
- Develop new ways of communication to ensure that the outcomes of ICH are well understood and widely disseminated
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ICH Considerations:
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ICH and Women
At the Steering Committee (SC) meeting held in November 2003, the SC agreed to establish an Informal Discussion Group to assess the adequacy of current ICH guidance concerning the participation of women in clinical trials.
In November 2004, the Informal Discussion Group presented the SC with the results of surveys undertaken in the three ICH regions which confirmed that women are, in general, adequately represented in trial populations. Since the findings did not support development of a separate ICH Guideline on women, the outcome of the surveys, including the review of existing ICH Guidelines and regional experiences were reported in an ICH Considerations document which was posted on the ICH website.
In Yokohama, in June 2009, the Considerations document was updated to include reference to relevant new and revised ICH Guidelines and to reflect the recognised distinction between the concepts sex and gender.
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ICH Considerations:
