Development of Advanced Therapy Medicinal Products in Europe

Livres blanc - 20 novembre 2018

Development of Advanced Therapy Medicinal Products in Europe

 

Advanced Therapy Medicinal Products are innovative and complex medicinal products for which successful development requires a good understanding of the applicable regulatory requirements.

 

This WhitePaper on Advanced Therapy Medicinal Products (ATMP) in Europe, adapted from the article published in the Gazette de l’AFAR N°94 in January 2017, provides:

  • A review of the regulatory background applicable to ATMP with a focus on the main measures laid down by the Regulation specifically applicable to ATMPs i.e. Regulation EC N° 1394/2007;
  • Points to consider for the development of these types of therapies;
  • An analysis of effectiveness and limitations of the measures laid down by the Regulation on ATMPs to foster the development of these medicinal products.

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