EMEA opens arms to small and medium sized biotech companies


The EMEA offers new services, and reduced fees to benefit Small & Medium-sized Enterprises ("SMEs") that use the EMEA for review and approval of new medicinal products. This is particularly important for the members of EuropaBio involved in healthcare, because the centralised procedure is mandatory for all biotech medicines and offers a European-wide marketing authorisation in the 25 EU Member States. The life science knowledge has generated around 1500 biotech based healthcare companies that are still in the SME category. The EMEA is implementing the new rules based on an EU Commission Regulation responding to the view widely held by SMEs that the EMEA procedures were not designed with smaller companies in mind, were cumbersome and more expensive than national medicines agencies.

The new EMEA benefits for SMEs include reduction of fees, deferral of payment of fees, taking over the responsibility for translations and offering administrative assistance in respect of these enterprises. The new services and reduced fees for SMEs are part of the implementing provisions in the new pharmaceutical legislation (Regulation (EC) No 726/2004) relating to SMEs. To implement this part of the Regulation, the EU Commission proposed a Fee Regulation that was adopted by the Council on November 14/15 2005 and the new SME Regulation, detailing SME specific provisions for companies developing medicinal products for human or veterinary use, which was adopted by the EU Commission on 15 December and is due to enter into force after publication in the Official Journal.

As part of the new deal, a special SME office will be installed at the EMEA. Its new head is Melanie Carr, previously with the Scientific Advice and Orphan Drugs Sector Pre-Authorisation Unit at the European Medicines Agency.

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