The area is mainly responsible for scientific advice processes, applications for clinical studies, marketing authorisations, indication extensions, single technology assessments and applications for reimbursement. The area has five units.
Unit for Regulatory Affairs 1
This unit is responsible for all regulatory assignments starting from scientific advisory services to marketing authorisations and indication extensions. The unit is involved in processes such as heading/leading and/or coordinating participation in EU assignments, representing Norway in CMDh and CMDv processes and horizon-scanning/early detection of pharmaceuticals in the pipeline.
The area has four units participating in assessment work through:
- providing scientific advice to pharmaceutical companies and the academia
- assessing applications for clinical trials
- assessing applications for marketing licenses and indication extensions
- assessing single technology assessments (STA’s) and applications for reimbursement
- representing Norway in EMA’s scientific committees