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EMEA expects 47 Rx marketing apps this year, as agency responsibilities grow.

Publication: Pharma Marketletter
Publication Date: 16-JAN-06
Format: Online
Delivery: Immediate Online Access
Full Article Title: EMEA expects 47 Rx marketing apps this year, as agency responsibilities grow.(European Medicines Evaluation Agency)

Article Excerpt
The European Medicines Agency (EMEA) is expecting to receive 47 Marketing Authorization Applications for new medicines in 2006, a marked increase over 2005's final total of 40, the EMEA's Management Board has announced.

Much of this increase is likely to be due to new legal provisions contained within the amended European Union pharmaceutical legislation which entered into force November 20, 2005 (Marketletters passim). For example, eight MAAs are expected to result from the Agency now being responsible for evaluating generic and "biosimilar" drugs, with further applications arising from its new role in...

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