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News about GMP/cGMP

2018-03-23

EMA Management Board: Highlights of the March 2018 Meeting

The European Medicines Agency (EMA) discussed the following points at its 15 March meeting in London:

 

  • Increasing availability of veterinary medicines for minor use and minor species
  • Review of clinical trial portal and database
  • Advanced therapies: achievements and challenges
    The term “Advanced Therapy Medicinal Products” (ATMPs) is used to designate gene therapies, somatic cell therapies and tissue engineered products.
    Achievements and continuing scientific and regulatory challenges relating to advanced therapies were presented by Dr. Martina Schüssler-Lenz, chair of EMA’s Committee for this field.
    Ten advanced therapies have been granted an EU-wide marketing authorisation since 2009. Four advanced therapies are currently under evaluation, including one cell-based and three gene-based therapies. For 2018, it is expected that four additional medicines will be getting evaluated.
  • Monitoring of EMA independence policies
  • Update on Brexit (as reported)
Source:

EMA: News and Events

 

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