The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies. The goal is to facilitate interaction among these types of companies. For now the, website includes details such as company contact information, activities, and number of employees. In March 2011, according to an EMA press release, the registry will also include information about company products, including what’s in the pipeline. To be included in the registry, companies must be based in the European Economic Area and have submitted to the agency an SME declaration per the European Commission Directive 2003/361/EC.
“This initiative is in line with the overall transparency policy of the Agency,” says the EMA release. The idea is to provide more information to the pubic and, in turn, to increase support for the 20 million SMEs located throughout the European Union.
EMA also has a dedicated SME Office, which provides assistance to companies regarding the development and authorization of drug products. For example, the agency offers help with regulatory procedures, translations, fee reductions, exemptions, and deferrals, says the EMA release. There is also a helpful Question and Answer section on the new registry for SMEs needing more information.
See PharmTech related articles:
EMA Publishes New Transparency Policy (ePT)
EMA Criticized over Transparency Rules (ePT)