Affiliations: Scientific Advice, Paediatrics and Orphan Drugs,
European Medicines Agency (EMA), London, UK. E-mail:
agnes.saint-raymond@ema.europa.eu
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.
Keywords: Innovation, pharmaceutical legislation, Road Map, EMA