Adaptive licensing methods such as those proposed by the European Medicines Agency (EMA) are indeed useful in the development of medicines for rare diseases, Martin Andrews, Senior Vice-President at GSK Rare Diseases, told the World Orphan Drugs Congress 2014 in Brussels, in November. He said that the ‘safe harbour’ dialogue provided for under EMA’s adaptive licensing pilot projects was of particular help. ‘The fact that the discussion can be very open is incredibly valuable when you are exploring an essential pathway,’ he said.
The EMA began inviting companies to participate in March 2014. The main aim of the pilot is to help develop an understanding of how future adaptive licensing pathways might be designed for different types of product and indication, according to EMA. The agency, drug manufacturers, patients’ representatives and other interested parties can explore different options in what it calls a safe harbour environment, considering detailed technical and scientific questions based on concrete examples.
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