EMEA Reports Successes In Inaugural 1995

Looking back on 1995 and its first year of business, the European Agency for the Evaluation of Medicinal Products sees itself as a success story. One year on from its inauguration on January 26, 1995, the EMEA and the new European centralized drug registration system have achieved results which go beyond previous expectations, says the agency.

The European Union's Committee for Proprietary Medicinal Products received 30 new applications for drug approvals last year; it processed ("converted") 18 applications outstanding under the old concertation procedure and, significantly, issued EU-wide approval on three converted products. The Committee for Veterinary Medicinal Products also achieved notable goals in 1995, granting approval for one product and making 182 recommendations to fix maximum residue limits (MRLs) for veterinary medicinal products by the end of 1996.

The support and commitment of all EU member states and the Commission in terms of time and resources has been a crucial element in the success of the EMEA. This solid support, according to the new regulatory body, has facilitated the smooth development of an agency and a system in which industry can have confidence - as shown by the 30 new applications for human medicinal products and two for veterinary drugs received or announced in the second half of 1995. Over two-thirds of these were voluntary applications which could have used alternative routes for authorization.