Safety Data Exchange Agreements (SDEAs) And Pharmacovigilance Agreements (PVAs) – An Overview

By Thomas Chatzopoulos, Vice President, QPPV Office; and Tariq Khan, Senior Consultant Pharmacovigilance, Alliance Management

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legally binding contract designed to clearly delineate and formalize the responsibilities and tasks related to the collection, exchange, and management of safety data between two or more parties. These agreements are typically established between license partners, pharmaceutical companies, or service providers, and can be implemented during both the development phase and the post-marketing phase of a product's lifecycle.

The primary purpose of an SDEA or PVA is to ensure that all parties involved in the development, distribution, or marketing of a medical product are fully compliant with legal and regulatory requirements concerning patient safety. By outlining specific roles and responsibilities, these agreements help to guarantee that accurate, timely, and comprehensive safety data is consistently collected, analyzed, and reported. This is crucial for the ongoing monitoring of a product's safety profile and for implementing necessary measures to protect patient health. Through these agreements, companies can establish a robust framework that supports effective pharmacovigilance, thereby ensuring that patient safety remains a top priority throughout the product's lifecycle.