EMA publishes QPPV Update

Recommendation

6/7 September 2023
Vienna, Austria

Drug Master File Procedures in the EU, the US and Japan
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

In April 2016 the European Medicines Agency (EMA) published the first issue of  the quarterly issued  "QPPV Update - What´s new in Pharmacovigilance". The "QPPV Update" replaces the "Pharmacovigilance Programme Update" which focused on information systems and services.

The new newsletter contains general information regarding pharmacovigilance and provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU pharmacovigilance.

The first issue of the "QPPV Update" covers the following topics:

• Pharmacovigilance in the product lifecycle,
• Pharmacovigilance processes,
• Pharmacovigilance guidance,
• Pharmacovigilance IT systems,
• Pharmacovigilance dialogue.

Qualified Persons for Pharmacovigilance (QPPVs) who are registered in the XEVMPD database according to Article 57 of Regulation (EG) No 726/2004 receive this document directly via EudraLink. You can find the Newsletter on the website of the EMA.