Table 1.

Overview of regulatory requirements for each country.

Country	International	National			Regional/local
	VHP	ECa	NCA	CCA	CTA	HEC/REC	Hospitalb	SIV
Estonia	×	×	×	×	×	–	×	×
Germany	×	×	×	×	×	×c	–	×
Greece	×	×	×	×	×	×	×	×
Hungary	×	×	×	×	×	×c	–	×
Italy	×	×	×	×	×	×	×	×
Norway	–	×	×	×	×	–	–	×
The Netherlands	–	×	×	×	×	–	×	×
Poland	–	×	×	×	×	×c	–	×
United Kingdom	×	×	×	×	×	×d	×	×

VHP: voluntary harmonisation procedure; CCA: Country Coordinator Agreement; EC: national ethics committee; NCA: National Competent Authority; CTA: clinical trial agreement; REC: regional ethics committee; HEC: hospital ethics committee; SIV: site initiation visit.

^aThe EC is the national ethics committee of a country or the leading ethics committee affiliated the hospital of the national coordinator.

^bHospital stands for local hospital approval.

^cNo separate submission is required, the EC or NCA contacts the REC for approval during the approval process.

^dReview by the UK’s NHS Research Scotland (NRS) and Health Research Authority (HRA) were categorised under REC.