Brussels, 16 Dec 2005
On 15 December the European Commission adopted a new regulation aimed at promoting the development of new medicinal products by small and medium sized enterprises (SMEs), by facilitating procedures for obtaining a European-wide marketing authorisation from the European Medicines Agency (EMEA).
The new regulation, which provides for a number of incentives and deferrals for SME companies that are developing medicinal products for human or veterinary use, responds to claims by SMEs in the sector that the EMEA procedures were not designed with them in mind. The new provisions address the specific needs of SMEs, which often lack regulatory resources and financial stability to cope with EU pharmaceutical legislation.
Commission Vice President Günter Verheugen declared: 'SMEs contribute much to innovation in the biotech and pharmaceutical sector. Fostering the competitiveness of those small but dynamic players is one concrete way to achieve our Growth and Jobs strategy, but also to support the development of new medicines.'
Key measures of the new regulation include fee exemptions or significant fee reductions and deferrals for a number of EMEA services for SMEs, such as scientific advice. Other provisions relate to administrative assistance, in particular regarding translations.
Following the adoption of the regulation, the European Medicines Agency (EMEA) has launched a 'one-stop shop' SME Office to provide administrative and procedural assistance to companies seeking to develop and market new medicines. At the beginning of 2006, EMEA will also develop a user guide on the administrative and procedural aspects of EU pharmaceutical legislation.
To qualify for these measures, businesses must meet the EU definition of an SME and send an email request to EMEA. The company's status as an SME will be reviewed annually.
The European association for bioindustries, EuropaBio, has expressed its satisfaction with the regulation, which it says affects around 1,500 biotech-based healthcare companies that fall into the SME category.
Andrea Rappagliosi, Chair of EuropaBio's Healthcare Council, said: 'These new rules are testament to the commitment of the EU Commission and the European Medicines Agency in acting on the needs of SMEs. This shows a very real recognition of the strategic role of Europe's small and medium sized biotech companies in contributing to the development of the medicines of the future.'
The regulation will enter into force following its publication in the Official Journal.