The European Medicines Agency (EMA) has released a huge number of new guidance documents regarding the format of risk-management plans (RMPs). The revised documents are an integral part of its new strategy on pharmacovigilance, which is the result legislation passed earlier in the year that overhauled the way postmarket surveillance is conducted in the EU.
The new guidances—16 in all—relate to a wide number of topics and product types, and provide an overview of how sponsors should fill out the new risk-management plan forms in the EU.
