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Tag Archives: personalised medicinal products

EMA envisage to link development of companion diagnostics and personalised medicines

The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface between personalised medicines and companion diagnostics. Companion diagnostics are defined by the In Vitro Diagnostic Regulation as a medical device which allows