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