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.
You may also be interested in...
Who’s Hired? Hikma Recruits New US Generics President
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.
Taro Agrees $36m Securities Settlement Over US Price-Fixing Claims
Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a firefighters’ pension fund accused the firm of misleading investors via its involvement in generic price fixing, leading to a fall in the price of its securities.