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Table 1 National rules on the CTA in the DEEP-2 countries

From: Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project

Country National rules National rule on paediatric trial GCP application
EU
Cyprus YES according to Directive 2001/20/EC [3] YES Implemented in the national Law
Greece YES according to Directive 2001/20/EC [3] YES Implemented in the national Law
Italy YES according to Directive 2001/20/EC [3] YES Implemented in the national Law
UK YES according to Directive 2001/20/EC [3]. Besides the EC approval and CA authorisation, another approval from the CRN-NHS highly recommended YES Implemented in the national Law
Non-EU
Albania NO NO Not implemented
Egypt YES but national law prevents to move biological samples beyond the borders YES Implemented but no legislative disposition exists
Tunisia YES paediatric trials with a non-marketed IMP not allowed Implemented but no legislative disposition exists