Over 40% of innovative medicines recommended for marketing authorisation in the European Union between 2010 and 2012 originated from small or medium-sized enterprises, says EMA.
According to an article published recently in Nature Reviews Drug Discovery, authored by staff members of the European Medicines.
Agency (EMA), small or medium-sized enterprises (SMEs), academia, public bodies and public-private partnerships are the ones getting out innovative medicines. In the article, all the medicines containing a new active substance that were recommended for marketing authorisation between 2010 and 2012 by the Agency’s Committee for Medicinal Products for Human Use (CHMP) were identified.
The findings show that almost one third (27%) of these medicines come from SMEs. At the same time SMEs account for only 13% of the marketing-authorisation holders. Furthermore, 17% originate from academic institutions, public bodies and public-private partnerships, states the EMA. Also, according to the findings, 61% of the medicines with an orphan designation originate from SMEs, while SMEs account for only 22% of the marketing-authorisation holders.
The authors state that “understanding the factors that could affect drug innovation, such as the nature of the organisations involved, could help in developing strategies to catalyse further advances. This analysis shows that SMEs, academic institutions, public bodies and public-private partnerships represent an important source of innovation and bolster the product pipelines of larger companies.”