BioWorld International Correspondent
BRUSSELS, Belgium - More than 100 smaller pharmaceutical companies from Europe - most of them biotech firms - have signed up for a European Union plan to give them easier access to the European Medicines Agency. The response to the agency's "SME office," set up a year ago to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs), has "exceeded expectations," said the agency.
The initiative is intended to promote innovation and the development of new medicines by SMEs, and the incentives available include administrative assistance from dedicated staff within the agency, fee reductions of up to 90 percent for scientific advice and inspections, deferrals and exemptions from fees for marketing authorization applications and help in translating product information documents for marketing authorization applications.
To qualify, companies must be independent, with fewer than 250 employees, and an annual turnover or balance sheet total of not more than €50 million ($65 million).
Assistance delivered during the first year of operation has included regulatory assistance via meetings or teleconferences on strategies for obtaining a marketing authorization or on applications for orphan designation. Scientific advice has been provided on quality, nonclinical and clinical aspects of applications and a total of €1.4 million in SME fee reductions has been processed for scientific advice. Companies that have submitted marketing authorization applications have so far benefitted from deferment of fees totalling €1 million. The agency also will hold a workshop for SMEs under the title "Navigating the regulatory maze," Feb. 2.