Common Application Form for Clinical Research with Human Cells Genetically Modified

On 6 November 2021 the European Commission published the updated version of the common application form for clinical research with human cells genetically modified.

This application form can only be used for:

  • human cells genetically modified by means of retro/lentiviral vectors, including genome edited cells, in cases where the applicant demonstrates that:

(1) there is no risk of formation of replication competent virus, and (2) residual infectious retro/lentiviral vector particles have been reduced to negligible concentrations in the finished product, or there is negligible risk associated with the presence of residual infectious viral vector particles in the finished product;

  • human cells genetically modified by means of adeno-associated viral vectors, including genome edited cells, in cases where the applicant demonstrates that there is no risk of formation of replication competent virus; and
  • human cells genetically modified without viral vectors, including genome edited cells.

This application form can be used for submissions in the following jurisdictions: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Portugal, Romania, Spain, Sweden, and Norway.

The application form must be accompanied by the SNIF (summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market) in the case of submissions that are made under Directive 2001/18/EC.

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