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Evolvement of european union regulations on innovative medicines

  • At: 2017 FIP Congress in Seoul (South Korea)
  • Type: Poster
  • By: AGIUS, Roberta (Malta)
  • Co-author(s): Roberta Agius: Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
    Francesca Wirth: Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
    Anthony Serracino Inglott: Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
  • Abstract:

    Background

    Regulatory requirements are a major reason affecting access to innovative medicines (IM). 

    Purpose

    To study the impact of European Union (EU) regulation regarding IM by investigating authorisation procedures. 

    Methods

    Analysis of EU regulatory tools developed to facilitate access to IM was undertaken. Conditional (CMA) and exceptional..

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Last update 4 October 2019

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