EMA Reports Progress for SMEs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-06-2015 18:05


The European Medicines Agency (EMA) has issued its annual report on micro-, small- and medium-sized enterprises (SMEs). The most recent SME report shows increased success rates for SME applications between 2011 and 2014 compared to the previous four-year period.

The agency put the SME initiative in place in December 2005 to promote innovation and development of medicines by SMEs. EMA’s SME Office provides regulatory, financial, and administrative support to registered SMEs in the development of their medicines. SMEs registered with the EMA also have access to a number of fee incentives. In 2014, EMA expanded its array of incentives to include post-authorization procedures.

Between 2011 and 2014, 62% of SME applications for marketing authorization were granted a positive opinion by EMA’s Committee for Medicinal Products for Human Use (CHMP) compared to 49% in the preceding four-year period between 2007 and 2010. The report also shows that in the past four years, 64% of SMEs requested scientific advice during the development of their medicines compared to 40% between 2007 and 2010.

In addition to receiving advice during the development of their medicine, a growing number of SMEs are using EMA’s biomarker qualification. Biomarkers can be used to identify subgroups of patients who will respond better to a medicine. Therefore, they have the potential to accelerate the development of more targeted medicines for certain diseases. Through the qualification procedure, EMA issues an opinion on the validity of the proposed biomarker tests.

"Initiating dialogue early with EMA and repeating it at major milestones during the development of a medicine is shown to be a key factor in reducing the risk of major objections when an application is assessed," said the EMA in a statement.

The report identifies areas that still cause difficulties when SMEs try to obtain a marketing authorization for a new human medicine. These include the quality and clinical modules of the application dossiers, in particular for biological medicines dossiers. To address this, EMA organized a workshop in April 2014 focusing on the quality of medicines containing chemical entities. For 2015, it is planning to dedicate its yearly workshop to quality aspects of biotechnology-derived medicines.

European Union (EU) policy has focused on providing esearch and financing initiatives to support companies during the research and development phase. These include Horizon 2020, the European Commission’s Research and Innovation program for 2014-2020, which was launched in January 2014. Horizon 2020 is the EU’s largest research and innovation program. It received a 30% increase in funding compared to the previous years’ programs. Horizon 2020 includes a dedicated instrument for SMEs. As part of this program, SMEs will be able to apply for the first time as single companies and not only as part of a consortium for funding for their innovative research and development projects.

Source: European Medicines Agency


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