Priority Medicines for Europe and the World 2013 Update. Background Paper 8 - New Approaches to Promoting Innovation. BP 8.2 - Regulatory Structures to Support Pharmaceutical Innovation
(2013; 54 pages)


In this Background Paper a to the 2013 Priority Medicines Report we describe developments in the system for marketing authorization of new medicines related to pharmaceutical innovation and meeting priority health care needs. In order to support the development of innovative medicines, and to properly address health care needs we propose research priorities for the regulatory system in the coming years. We consider relevant developments at four levels: the overall system of marketing authorization; key components of the system; specific regulations within the system; and broader developments surrounding the system.

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