Bulgarian pharma views EU accession

A workshop on European Accession and Required Regulatory Activities was held in Sofia, Bulgaria, this month, reports the Association of Research-based Pharmaceutical Manufacturers of Bulgaria (ARParM). Topics discussed related to the authorities and industry legislation activities prior to the country's accession to the European Union as well as improving cooperation between them.

Taking part in this workshop were speakers from the European Medicines Agency (EMEA), Bulgarian Drug Agency and the European Federation of Pharmaceutical Industries and Association, who were greeted on behalf of the Ministry of Health by Svetlana Spasova, Director of National Health Policy department.

Representatives of the national regulatory authorities and the pharmaceutical industry agreed on a statement that joint efforts and cooperation are needed to overcome the pre-accession regulatory challenges in order to guarantee stability in the medicines supply for Bulgaria and the smooth incorporation of European regulatory requirements, reports the ARParM.