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EMEA opens SME Office to support drug development

Date published: 19/12/2005

The European Medicines Agency (EMEA) has launched an SME Office to provide administrative and procedural assistance to small and medium-sized enterprises (SMEs) seeking to develop and market new medicines. The launch comes on the back of new European Commission regulations aimed at promoting innovation and the development of new medicinal products by SMEs.

SMEs that are developing medicinal products for human or veterinary use will be able to benefit from a number of incentives, including: administrative and procedural assistance from a dedicated group of people within the SME Office at the agency and fee reductions for scientific advice and inspections.

The office will also offer deferral of the fee payable for an application for marketing authorisation or related inspection. In addition, assistance with translations of the product-information documents submitted in the application for marketing authorisation will be offered.

To determine which companies are eligible for SME incentives, the EMEA will apply the definition of micro, small and medium-sized enterprises provided in European Commission Recommendation 2003/361/EC.

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