Independent status for Bulgarian regulator:
This article was originally published in Clinica
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...
Dr Reddy's is poised to expand its OTC offering in Russia and certain CIS countries by snapping up a basket of allergy brands from fellow Indian firm Glenmark.
Sandoz has launched an awareness campaign under the banner of “Ask For Generics” in the US. The initiative is aiming to educate stakeholders on the benefits of generics and their quality, safety and efficacy.
European Commission proposals for strengthening intellectual property protections in the EU, particularly the supplementary protection certificate (SPC) system, have been broadly welcomed by Europe’s brand industry. But the medical NGO, MSF, says the SPC proposals run counter to the commission’s own efforts to improve access to medicines.