Micro-, small- and medium-sized enterprises (SMEs) are making better use of the various regulatory tools that the European Medicines Agency’s (EMA) has put in place to support them during the development of their medicines.
In addition, between 2011 and 2014, 62% of SME applications for marketing authorisation 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.
These are some of the highlights of the EMA 2014 SME annual report which analyses the outcome of applications for marketing authorisation of new medicines submitted by SMEs since the start of EMA’s SME initiative in 2005.
The report 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.
The report identifies areas that still cause difficulties when SMEs try to obtain a marketing authorisation 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 organised 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.
Dedicated support to SMEs as part of Horizon 2020
SMEs are a motor of innovation in the European Union (EU). Recognising their role in the development of innovative medicines, major research and financing initiatives have been launched at EU level to support the companies during the research and development phase.
These include Horizon 2020, the European Commission’s Research and Innovation programme for 2014-2020, which was launched in January 2014.Horizon 2020 is the EU’s biggest research and innovation programme. It received a 30% increase in funding compared to previous years’ programmes.
Horizon 2020 includes 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 their innovative research and development projects.
Further information on Horizon 2020 can be found in an EMA’s note on this issue that has been published today, with an overview of current initiatives at EU level to assist SMEs with financing.
About EMA’s SME initiative
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 EMA also have access to a number of fee incentives. In 2014, EMA expanded its array of incentives to include post-authorisation procedures.