EMEA Doors Now Open For Business

After many trials and tribulations - and awaiting approval of the fee structure (Marketletters passim), February 1 saw the actual opening for business of the European Medicines Evaluation Agency. Now, for the first time, the EMEA will be able to issue a single drug approval for the entire European market. As a result, innovative new products should reach patients more efficiently than has been possible under the old nationally-based approval system.

Ahead of this, and after the formal inauguration (see also story alongside), the European Federation of Pharmaceutical Industries Associations held its EFPIA-Info 95 meeting, at which EMEA executive director Fernand Sauer confirmed that drug registration dossiers under the European Union's multistate system could be accepted from February 1.

Reiterating much of what had been said at the inauguration ceremony, Mr Sauer also noted that the function of the R&D advisory committee was still an open question, but that the aim is for pharmaceutical companies to have the availability of early consultation with the EMEA, and that national drug regulatory authorities have not been dismantled, but rather that they will be required to play a dynamic role, including producing experts for both European and national procedures.