The strategy aims to ensure Europe’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts.

The European Commission has released a roadmap document on regulatory reform in the EU to address shortages, access to medicines and innovation.

The document states the pharmaceutical sector is a major contributor to the EU economy with 842,000 direct jobs and an €91 billion trade surplus in 2018. At the same time, the EU has an ageing population, a rising burden of diseases and is faced with emerging health threats such as the coronavirus. The report calls for a 'holistic, patient-centred, forward-looking EU Pharmaceutical Strategy which covers the whole life-cycle of pharmaceutical products from scientific discovery to authorization and patient access.

Seven key challenges are identified in the document, followed by four specific objectives to be pursued through legislative and non-legislative actions. 

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