Pharmacovigilance Programme Update From EMA

The Update is the first in a series of documents primarily aimed at providing marketing - authorisation holders (MAHs) with information on the development of the enhanced systems, helping MAHs prepare for the business change to come. Update documents will be issued quarterly.

Topics addressed in this first issue are:

• Article 57 data submission
• Medical literature monitoring
• Adverse drug reaction reporting and signal management (revised EudraVigilance access policy)
• Public website of suspected adverse reactions
• PSUR repository
• Pharmacovigilance fees

The new update can be reviewed at: Pharmacovigilance Programme Update