Rna-based drugs and regulation: toward a necessary evolution of the definitions issued from the european union legislation

HIGHLIGHTS

  • who: Mathieu Guerriaud from the melweis University, Hungary France have published the research: RNA-based drugs and regulation: Toward a necessary evolution of the definitions issued from the European union legislation, in the Journal: (JOURNAL)
  • what: To help to categorize RNA-based drugs according to the current rules, the authors propose a flowchart .
  • future: The forthcoming revision of European regulations which should incorporate the ICH definition could lead to a greater clarity in categorization but vigilance will be required since a minor change in the regulations could have unexpected cascading repercussions on future . . .

     

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