In an attempt to promote drug development by young and innovative companies in Europe, the London-based European Medicines Agency (EMEA) unveiled a new storefront targeted at small and medium-sized enterprises (SMEs).
On December 15, 2005, the EU’s central drug-regulating agency opened a dedicated ‘SME Office,’ that will offer administrative and procedural assistance to companies trying to develop or market new drugs.
Through the new office, scientific advice and inspections will be available at sharply reduced prices. Fees could be waived altogether if marketing application of a new human or veterinary drug ends unsuccessfully. The office will also assist in translating documents into the EU’s 20 official languages.
Industry groups enthusiastically welcomed the initiative, for which they had lobbied hard. However, for the new fees and services really to make a difference, more companies will need to be able to profit from them, says Laurens Theunis, director of the Emerging Enterprises Council at EuropaBio, a Brussels-based industry group representing over 1,200 SMEs.
Caroline Ruggieri, executive manager of Emerging Biopharmaceutical Enterprises (EBE), another Brussels-based industry group, agrees. EBE believes the European Commission’s definition of ‘micro, small and medium-sized enterprises’ is “restrictive,” says Ruggieri, who hopes consultations on broadening the definition could be opened by the Commission as soon as next March.