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Guiding principles for joint FDA EMEA voluntary genomic data submission briefing meetings agreed
Published 31/05/2006

The European Medicines Agency, the European Commission and the U.S. Food and Drug Administration (FDA) have agreed to a procedure for joint FDA EMEA briefing meetings with sponsors following voluntary submission of genomic data

Read the public statement here
Read the guiding principles document here

EMEA publishes Road Map status report
Published 24/05/2006

The European Medicines Agency has published the first report on the implementation status of its long-term strategy, the EMEA Road Map to 2010. Status reports will be published annually to monitor the progress made in implementing the actions and initiatives set out in the Agency’s long-term strategy.

Read the status report here
Read more about the EMEA Road Map here

New, faster scientific advice procedure finalised
Published 24/05/2006

The European Medicines Agency has finalised a new procedure for the provision of scientific advice and protocol assistance to sponsors developing medicinal products. The main features of the procedure include the earlier and greater involvement of external experts in developing advice, and a faster delivery of the advice to sponsors.

Read the press release here
Read the ‘New Framework for Scientific Advice & Protocol assistance here

Latest Press Releases...
14/06/06 CHMP Monthly Report from the May 2006 Plenary Session
14/06/06 HMPC Meeting Report from the 11-12 May 2006
12/06/06 Management Board Press Release: EMEA Management Board moves for greater transparency
08/06/06 EMEA Press Release Pharm Research Associates (UK) Ltd withdraws marketing authorisation application for Surfaxin
06/06/06 CHMP Press Release European Medicines Agency adopts a positive opinion for the use of Prozac in the treatment of children and adolescents suffering from depression
02/06/06 EMEA Press Release European Quality Leader of the year 2006' award goes to EMEA staff member
02/06/06 EMEA Press Release European Medicines Agency adopts first positive opinion for a medicinal product derived from transgenic biotechnology
01/06/06 EMEA Press Release European Medicines Agency introduces new, faster scientific advice procedure rev 2
31/05/06 EMEA Public Statement - EU (European Commission and EMEA) and FDA agree on guiding principles for joint FDA EMEA voluntary genomic data submission briefing meetings
22/05/06 EMEA Press Release - CIS bio international withdraw their application for SCINTIMUN (besilesomab)
19/05/06 CVMP Press Release from the May Plenary session
18/05/06 COMP Press Release from the May Plenary Session
08/05/06 EMEA Press Release European Medicines Agency finds no signal for decreased effectiveness of HBVAXPRO and Procomvax
06/04/06 EMEA Press Release Novo Nordisk withdraw their application to extend the marketing authorisation for NovoSeven
Click here For Press Archives...
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