The EMA also released its report on its small and medium-sized enterprises (SME) initiative, which marked its 10th anniversary in 2015. The aim of the initiative was to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) through a dedicated instrument, the SME Office, addressing the needs of smaller companies in the pharmaceutical sector. This is especially important for orphan medicinal products as a considerable number of important and innovative products in this area are produced by the SMEs.
While reviewing the 10 year experience, the report highlights that 42% of the products that have received a positive opinion are orphan medicinal products while 3% are advanced therapy medicinal products. In 2015, the number of protocol assistance for orphan drugs developed by SMEs represented 44% of all protocol assistance procedures.
The report also emphasizes that the majority of products that received a positive opinion by the CHMP was authorized on the basis of article 8(3) of Directive 2001/83/EC and contained a new active substance. The report highlights that there was 75% success rate, between 2006-2014, for marketing authorization for products sponsored by the SME applicants, clearly underscoring the success of the initiative.