EMA has published today a report highlighting the Agency’s support for micro, small and medium-sized enterprises (SMEs). The report features key facts and figures of companies that are registered as SMEs with EMA and covers the period from 2016 to 2020.

Since 2016, the success rate of marketing authorisation applications for human medicines submitted by SMEs has more than doubled, reaching 89% in 2020. In 2020 alone, SMEs were behind 16 recommendations for approval of a new medicine. This accounted for almost 20% of all medicines for human use recommended for approval by EMA last year. Half of them targeted rare diseases.

In the veterinary area, 14 medicines received a positive opinion by the Agency in the last five years. Almost half of these had received scientific advice from the Agency. Six out of the 14 were veterinary medicines for minor-use / minor species (MUMS).

The publication of the report marks the 15-year anniversary of the adoption of the SME Regulation, which promotes innovation and the development of new medicines for human and veterinary use in Europe. For additional information, see reports on the EMA roundtable with stakeholders on the 15-year anniversary of the SME Regulation, outcome of the SME Office's 2020 survey, SME office webpage and dedicated EMA News announcement.