Encode: Clinical research regulatory affairs

Regulatory Affairs

During planning and preparation for study startup, the Clinical Operations team works closely together with the sponsor and investigators in preparation and submission of the clinical trial authorisation (CTA) request.

Several CTA submission documents, including all subject related documents and local application forms, must be submitted in local language, Icelandic. All other documents may be submitted in English.

Encode offers translation services of any study related documents and regulatory/ethics correspondence. Encode also has a long term working relationship with certified translators in Reykjavik, in case certification is requested.

The regulatory environment

Iceland is a member of the European Economic Area, and European Union directives are adopted in Iceland through local legislation.

The European Clinical Trials Directive 2001/20/EC came into effect in Iceland in May 2004 with implementation of Regulation no. 443/2004 on clinical trials of medicinal products in humans. The regulation impacts IMCA and NBC operations and refers to Act no. 77/2000 on the protection of privacy as regards to the processing of personal data.

Applications for clinical trials in Iceland are made to three governmental bodies:

• The Icelandic Medicines Control Agency, IMCA
• The National Bioethics Committee, NBC
• The Data Protection Authority, DPA

For non-interventional studies, approval from the IMCA is not required.

The review process

Maximum review time is 60 days from receipt of a valid application at the NBC and the IMCA
Both govermental bodies may send a single request for additional information or clarification during the review period
The IMCA will make every effort to send a deficiency notification within 30 days of the receipt of a valid application but does not have scheduled meetings
The NBC has scheduled meetings every two weeks, dates for meetings can be found on the NBC website
The DPA typically responds within 4-6 weeks but there is no legally binding time period within which the DPA must respond
Maximum review time for amendments at the IMCA and NBC is 35 days


About ENCODE		Clinical Operations	Regulatory Affairs	Clinic Services
	Regulatory Affairs During planning and preparation for study startup, the Clinical Operations team works closely together with the sponsor and investigators in preparation and submission of the clinical trial authorisation (CTA) request. Several CTA submission documents, including all subject related documents and local application forms, must be submitted in local language, Icelandic. All other documents may be submitted in English. Encode offers translation services of any study related documents and regulatory/ethics correspondence. Encode also has a long term working relationship with certified translators in Reykjavik, in case certification is requested. The regulatory environment Iceland is a member of the European Economic Area, and European Union directives are adopted in Iceland through local legislation. The European Clinical Trials Directive 2001/20/EC came into effect in Iceland in May 2004 with implementation of Regulation no. 443/2004 on clinical trials of medicinal products in humans. The regulation impacts IMCA and NBC operations and refers to Act no. 77/2000 on the protection of privacy as regards to the processing of personal data. Applications for clinical trials in Iceland are made to three governmental bodies: • The Icelandic Medicines Control Agency, IMCA • The National Bioethics Committee, NBC • The Data Protection Authority, DPA For non-interventional studies, approval from the IMCA is not required. The review process Maximum review time is 60 days from receipt of a valid application at the NBC and the IMCA Both govermental bodies may send a single request for additional information or clarification during the review period The IMCA will make every effort to send a deficiency notification within 30 days of the receipt of a valid application but does not have scheduled meetings The NBC has scheduled meetings every two weeks, dates for meetings can be found on the NBC website The DPA typically responds within 4-6 weeks but there is no legally binding time period within which the DPA must respond Maximum review time for amendments at the IMCA and NBC is 35 days