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Master Thesis

Accès précoce des médicaments au marché (2004-2019)

Abstract : The regulatory context and challenges have drastically changed over the last few years, leading European member states to wonder about how to bring innovative drugs into their healthcare systems. These innovations can sometimes give patients with life-threatening condition a chance to survive and heal. To help address unmet medical needs, the European Medicines Agency (EMA) has introduced « conditional » and « under exceptional circumstances » marketing authorisations. The Agency has also introduced regulatory programmes to support and promote the development of innovative medicines, such as PRIority MEdicines (PRIME) and Adaptive pathway. National programs have also been launched, in response to the European Compassionate Use regulation (EC) N°726/2004. However, strong discrepancies can be observed such as between the Temporary Use Authorization (ATU) in effect since 1994 in France and the Early Access Medicines Scheme (EAMS) launched in 2014 in the United Kingdom. The objective of these processes is to ensure early market access thanks to a shorter drug development and/or evaluation. The aim of this thesis is to present these processes, to analyse quantitative and qualitative data and to explore the emerging concerns. The evaluation of these innovative medicines is often based on fewer data than usual, which has raised questions about patient safety. In order to soothe these concerns, the EMA regularly publishes reports on these processes and has put in place dialogues with health actors to promote interactions. The main objective of health agencies is to continue facilitating early access of medicines to patients but also to implement and enforce adherence to regulatory standards to ensure access to safe medicines with added value.
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Master Thesis
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  • HAL Id : dumas-03160757, version 1



Manon Dutouya. Accès précoce des médicaments au marché (2004-2019). Sciences du Vivant [q-bio]. 2020. ⟨dumas-03160757⟩



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