ICH M6 Gene Therapy Guidelines


M6 Gene Therapy

M6 Virus and Gene Therapy Vector Shedding and Transmission

This new topic was endorsed by the ICH Steering Committee in September 2009.

In September 2009, following the finalization by the ICH Gene Therapy Discussion Group (GTDG) of the ICH Consideration document “General Principles to Address Virus and Vector Shedding”, the ICH Steering Committee endorsed the development of an ICH Guideline on this topic with the aim of providing more extensive information to improve harmonization amongst the ICH regions.

This new topic was subsequently assigned the code “M6”. In April 2011, this topic was ceased following the ICH Steering Committee discussion. The decision was based on the opinion that the current state of science and related resource allocation would not allow this topic to be supported as a topic for harmonization.

Endorsed Documents (Click the links below for complete guidelines)

Other Documents (Click the links below for complete guidelines)

*These Guidelines Belongs to ICH website.

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