Better use of support mechanisms put in place by the European Medicines Agency has increased the success rate of SMEs applying for approval of new medicines
The annual SME report from the European Medicines (EMA) shows increased success rates for small companies applying for marketing approval for new drugs between 2011 and 2014, compared to previous four-year period
The agency claims this is the result of SMEs making better use of the various regulatory tools it has put in place to support them during drug development.
Between 2011 and 2014, a total of 62 per cent of SME applications for marketing authorisation were recommended for approval, compared to 49 per cent in the four years from 2007 to 2010.
The 2014 report shows that in the past four years 64 per cent of SMEs requested scientific advice during drug development, compared to 40 per cent between 2007 and 2010.
In addition, a growing number of SMEs are using EMA’s biomarker qualification, to identify subgroups of patients who are likely to respond better to a drug. This provides the potential to accelerate development of more targeted products for certain diseases.
Major milestones
Starting to talk to the EMA at the early stages of clinical development and referring back to the agency when major milestones are passed, has been shown to be a key factor in reducing the risk of major objections from the EMA when a marketing application is assessed.
A total of 1,301 SME companies were registered with the EMA at the end of 2014, an increase of 3 per cent compared to 2013. A streamlined SME validation process introduced in 2011-2012 had a significant impact on the time taken for the agency to agree SME status, which now takes an average of 12 days, against 21 days in 2012.
A revised process for SME assignment and renewal is due to be rolled out in 2015, to further ease the administrative burden of applying for SME qualification. The EMA says that its SME office is working with other EU institutions and agencies to promote synergies and exchange best practices on the European Union’s definition of SME, the SME qualification process, and financing and support for innovation.
In total, 72 per cent of the registered SME companies are biotechs developing products for human use, while 5 per cent are veterinary companies, and 6 per cent are developing products for both human and veterinary use. The remaining 17 per cent are service providers to the pharmaceutical industry.
The size of companies remained the same as previous years with around 45 per cent having fewer than10 staff and turnover and balance sheets of less than €2 million.
The geographic distribution is also unchanged, with 19 per cent based in based in the UK, 13 per cent in Germany and 9 per cent, France.
A total of 11 per cent of registered companies are academic spin-offs, and 9 per cent were formed in the last three years.
The report identifies areas that still cause difficulties when SMEs apply for approval for a new drug, including issues with the quality of application dossiers.
Support for SMEs in Horizon 2020
The EMA also draws the attention of SMEs to the research and financing initiatives available at EU level to support companies during the research and development phase, including Horizon 2020, which has a dedicated instrument for SMEs.
As part of this programme, SMEs will be able to apply for the first time as single companies and not only as part of a consortium for funding for research and development projects.
The EMA started the SME support scheme in December 2005. The agency’s SME Office provides regulatory, financial and administrative support to registered SMEs. In addition, SMEs have access to a number of fee incentives.
The agency claims this is the result of SMEs making better use of the various regulatory tools it has put in place to support them during drug development.
Between 2011 and 2014, a total of 62 per cent of SME applications for marketing authorisation were recommended for approval, compared to 49 per cent in the four years from 2007 to 2010.
The 2014 report shows that in the past four years 64 per cent of SMEs requested scientific advice during drug development, compared to 40 per cent between 2007 and 2010.
In addition, a growing number of SMEs are using EMA’s biomarker qualification, to identify subgroups of patients who are likely to respond better to a drug. This provides the potential to accelerate development of more targeted products for certain diseases.
Major milestones
Starting to talk to the EMA at the early stages of clinical development and referring back to the agency when major milestones are passed, has been shown to be a key factor in reducing the risk of major objections from the EMA when a marketing application is assessed.
A total of 1,301 SME companies were registered with the EMA at the end of 2014, an increase of 3 per cent compared to 2013. A streamlined SME validation process introduced in 2011-2012 had a significant impact on the time taken for the agency to agree SME status, which now takes an average of 12 days, against 21 days in 2012.
A revised process for SME assignment and renewal is due to be rolled out in 2015, to further ease the administrative burden of applying for SME qualification. The EMA says that its SME office is working with other EU institutions and agencies to promote synergies and exchange best practices on the European Union’s definition of SME, the SME qualification process, and financing and support for innovation.
In total, 72 per cent of the registered SME companies are biotechs developing products for human use, while 5 per cent are veterinary companies, and 6 per cent are developing products for both human and veterinary use. The remaining 17 per cent are service providers to the pharmaceutical industry.
The size of companies remained the same as previous years with around 45 per cent having fewer than10 staff and turnover and balance sheets of less than €2 million.
The geographic distribution is also unchanged, with 19 per cent based in based in the UK, 13 per cent in Germany and 9 per cent, France.
A total of 11 per cent of registered companies are academic spin-offs, and 9 per cent were formed in the last three years.
The report identifies areas that still cause difficulties when SMEs apply for approval for a new drug, including issues with the quality of application dossiers.
Support for SMEs in Horizon 2020
The EMA also draws the attention of SMEs to the research and financing initiatives available at EU level to support companies during the research and development phase, including Horizon 2020, which has a dedicated instrument for SMEs.
As part of this programme, SMEs will be able to apply for the first time as single companies and not only as part of a consortium for funding for research and development projects.
The EMA started the SME support scheme in December 2005. The agency’s SME Office provides regulatory, financial and administrative support to registered SMEs. In addition, SMEs have access to a number of fee incentives.
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