[Contributed by Mirela Tudor, Senior Specialist, Late Stage Submissions Group, inVentiv Health Clinical]
The National Ethics Committee is now the “National Bioethics Committee of Medicines and Medical Research-2Devices (CNBMDM)” which has now taken full responsibility for evaluation and approval of clinical studies with human medicines and medical devices in Romania (press note dated 5th February 2014)
There is only one Ethics Committee, The National Bioethics Committee of Medicines and Medical Devices enabled to evaluate and approve clinical studies in Romania, most of the local ECs are not ICH/ GCP compliance. Submission to Ethics is done in parallel with the ANMDM and study cannot start without written approval received within 60 days).