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Regulatory News and Updates

New EU Guidelines on Module 3 Content

The European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). This guideline comes into effect in January 2018.

The guideline offers clarification on the type and level of information that should be included in the common technical document (CTD) Module 3 of the MAA dossier with respect to the manufacturing process description.