Category Regulatory guidelines

EMA issues draft guideline on core SmPC, labelling and package leaflet for ATMPs containing genetically modified cells

The European Medicines Agency (EMA) has issued a draft guideline for comments, on core Summary of Products Characteristics (SmPC), labelling and package Leaflet for ATMPS containing genetically modified cells. What is the legal basis of the guideline? This guideline should…

Read MoreEMA issues draft guideline on core SmPC, labelling and package leaflet for ATMPs containing genetically modified cells