OctreoPharm Sciences granted SME status by the EMA

OctreoPharm Sciences GmbH, a medicine developer and specialist for radioactive labeled contrast agents in nuclear medicine has been granted SME status as small-sized enterprise in research and development by the European Medicine Agency EMA. This classification will reduce the fees OctreoPharm has to pay in the regulatory procedures for their products. Moreover, the company may now have easier and more economical access to various services provided by EMA.

The SME program and register is an initiative of the European Union geared to the requirements of small and medium-sized enterprises in Europe that are active in the field of developing and researching innovative medicine products. Companies with SME status may receive additional consultation, information and training if needed, given by specifically dedicated staff of the European regulatory agency. This brings major benefits for the companies in the central regulatory process including, amongst others, lower fees of up to 90 % as well as simplified payment transactions and free-of-charge translation into the EU languages, plus administrative and scientific support on behalf of EMA.

"The fact that OctreoPharm has now been given SME status is of great advantage in the continued development and registration process of our current product candidate SOMscan(R). We will have major benefits due to the SME initiative by EMA," was the comment given by Udo Blaseg, Managing Partner of OctreoPharm Sciences GmbH. "The SME status makes a major impact, things become much easier and we receive more support when applying for central registration for our products, which will now be faster and more cost effective."