Updated EU Guideline On Manufacturing Finished Dosage Forms Addresses Supply Chain Complexities
New EU guidance will help companies preparing marketing authorization applications understand what to include in Module 3 of their common technical document.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
New medicines under evaluation at the European Medicines Agency.
The European Medicine Agency has recommended extending the therapeutic indication of a raft of drugs that are already authorized in the EU.