Abstract
The strategy for innovation at EMA is defined in the Pharmaceutical Legislation (Reg (EC) No 726/2004). EMA has also outlined a Road Map up to 2010 with two main objectives: to stimulate research and innovation from pharmaceutical and biotechnology enterprises within Europe, and to address hurdles encountered during innovative drug development [1].
In order to support the activities on innovative products, the pharmaceutical legislation offers the definitions and references for innovative medicines.
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