ICH guideline

ICH M6: Virus and Gene Therapy Vector Shedding and Transmission

ICH guideline · Multidisciplinary Guidelines

Key facts

ICH code M6
Title Virus and Gene Therapy Vector Shedding and Transmission
Guideline series Multidisciplinary Guidelines
ICH summary (excerpt) This new topic was endorsed by the ICH Steering Committee in September 2009.   In September 2009, following the finalisation 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…
File M6 Appendix 2
File type PDF
File on ich.org database.ich.org

At a glance

  • Yes Full text searchable in Orca1
  • M6 Appendix 2 Files published by ICH
  • None FDA guidance documents based on this guideline

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About ICH guidelines

ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.

Source: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline summaries are ICH material, reproduced with acknowledgement

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