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Regulatory News | 04 February 2015 | By Michael Mezher
The European Medicines Agency (EMA) says that its tools designed to aid micro-, small- and medium-sized enterprises (SMEs) have increased those companies’ success in obtaining authorization for their products. The agency released a report this week highlighting the growth and success of the program.
The European Commission (EC) found that a number of hurdles, including procedural and financial steps involved in obtaining marketing authorization, heavily affected SMEs.
The commission sought to address these hurdles by adopting Regulation (EC) No. 2049/2005, which established a number of incentives designed to assist SMEs in these critical areas.
For the definition of SMEs please see Commission Recommendation 2003/361/EC.
Regulation (EC) No. 2049/2005 provides SMEs with fee reductions, deferrals and exemptions; administrative, scientific and procedural advice; as well as translation services for certain required documents.
The commission states that SMEs “are often innovative companies … active in the fields of gene or somatic cell therapy,” and hopes that offering these incentives can spur the development of new therapies.
Since the adoption of (EC) No. 2049/2005 SMEs submitted 127 marketing authorization applications to EMA, 107 of which were for human medicines.
EMA reports a significant increase in the number of marketing authorizations granted to SMEs from 2011 to 2014 versus the previous four-year period. The agency says 62% of SME applications were given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), up 13% from 2007 through 2010.
The agency also found that more SMEs asked for scientific advice, citing a 24% increase from 2011-2014 over the 2007-2010 period.
EMA’s SME office found SMEs still struggled with the quality and clinical portions of their submissions. The office says that “46% of major objections were on the quality documentation, 47% on the clinical efficacy and safety documentation.” The office also found that the number of objections an application received varied greatly depending on whether the product was a chemical or biological entity and found these products received 6 and 15 objections on average, respectively.
EMA calls SMEs “a motor of innovation in the EU” and says there will continue to be EU level initiatives to assist these companies while they are in the research and development phase.
To address one of the deficits outlined in its report, EMA will host a workshop in 2015 designed to help SMEs with quality aspects related to biologics.
The agency also points to EU-level support for SMEs such as Horizon 2020, a program designed to promote research and innovation. Horizon 2020 has a budget of €80 billion through 2020 and allows individual SMEs to receive up to €5 million in investment for research and development projects.
Tags: SMEs, Small and Medium Sized Enterprises, Scientific Advice