Independent status for Bulgarian regulator:
This article was originally published in Clinica
Executive Summary
The Bulgarian Council of Ministries has published an act making the National Drug Institute, which includes the medical devices regulatory department, an independent authority of the state rather than a special authority under the Ministry of Health. The measure removes the regulator from the administrative structure of the health ministry and establishes it as a stand-alone body. The director of the institute, however, will continue to report to the Minister of Health. The institute will finance its activities from fee income and has a staff of 136 people, according to its director, Dr Borislav Borissov.