NLGeneTherapy object

Specific requirements

Yes

Applicable legal framework

Advanced therapies, like gene therapy, cell therapy and therapies involving genetic modifications have additional restrictions implemented as stated in The Act on Pharmaceutical Law of 6 September 2001, Dz.U. 2008, No 45, item 271.
A clinical study involving these therapies can only be started after the President of URPL issued his/her approval for the study. The President can prolong his/her time for issuing an approval to 90 days if an expert opinion is needed for clinical studies on gene therapy, cell therapy and therapies involving genetic modifications (Art. 37p.). Manufacturing of these agents has to be regulated specifically by the directive of the Ministry of Health.

Additional Information

Harvesting, storage and transplantation of cells, tissue and organs are regulated with additional restrictions and must have agreements from the Ministry of Health and the Centre for Organization and Coordination for Transplantation POLTRANSPLANT and the National Transplantation Council.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395