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May 28, 2013
GeneQuine classified as SME
The European Medicines Agency (EMA) classified GeneQuine as SME (micro, small and medium-sized enterprise).
This makes GeneQuine eligible to benefit from the provisions for administrative and financial assistance laid down in Regulation (EC) 2049/2005.
The EU incentives offered by the EMA include regulatory, administrative and procedural assistance from the Agency's SME office, 90 % fee reduction for scientific advice and inspections, fee exemption for certain administrative services, fee deferral / conditional fee exemption for application for marketing authorization, assistance with translation of the product information documents and certification of quality / non-clinical data for advanced therapy medicinal procucts for human use (ATMPs). Data certification facilitates the evaluation of any future application for clinical trials and marketing authorization.
These benefits provide a valuable financial incentive and helpful administrative support for GeneQuine on the way to marketing authorization of its gene therapy products.