EMA’s SME Initiative Shows Positive Results

The European Medicines Agency (EMA) published a report on May 11, 2016 summarizing the past 10 years of the agency’s small- and medium-sized enterprise (SME) initiative, which began in December 2015. The report highlights how the initiative has enhanced the role of SMEs in pharma innovation. EMA also published the results of a survey of SMEs and their thoughts on the initiative.

According to EMA, SMEs make up 99% of all business in the European Union, and pharmaceutical SMEs play a major role in the development of new medications. According to the report, SMEs account for approximately 10–15% of marketing authorization applications. More than one in two drugs developed by SMEs that were recommended for market authorization in the past 10 years contained new active substances suggesting that SMEs have the potential to address unmet patient needs and be a major source of innovation. Because of the importance of SMEs, the agency’s SME Office provides regulatory, financial, and administrative support to registered SMEs. There are 1619 EMA registered SMEs, as of the end of 2015.

The SME Initiative appears to be leading to more market authorizations; in 2015, 75% of SME applications were approved for marketing authorization, compared to 68% from 2010–2012. And scientific advice provided through the SME initiative appears to have been beneficial; 158 of the 473 requests for scientific advice finalized by EMA in 2015 came from SMEs, 30% more than in 2014.

A survey of SMEs and stakeholders indicates that services provided by the initiative have been relevant and beneficial. Survey respondents rated financial incentives, the SME newsletter, the SME user guide, and regulatory assistance highest among the services provided. EMA stated in a press release that, “According to the survey results, regulatory requirements, the administrative burden, and the cost of regulatory procedures are the most frequent challenges that SMEs are facing today.”

“The report shows that EMA’s tools to support pharmaceutical innovation by SMEs, and in particular scientific advice, are being increasingly used,” explained Melanie Carr, head of EMA’s Stakeholders and Communication Division, in the press release. “Encouraging small enterprises to engage in dialogue with us early in the product development is a priority for EMA as the input we provide allows them to optimize their development program and generate high quality data on a medicine’s benefits and risks.”

Source: EMA