Eudravigilance

Eudravigilance is the European Union (EU) system for the collection, management, and analysis of adverse event reports in relation to medical products authorized for use in the EU. The system is managed by the European Medicines Agency (EMA) and is used to monitor the safety of all medicinal products, including prescription and over-the-counter medicines, traditional herbal medicines, and vaccines.

Eudravigilance is used to:

1. Facilitate the reporting and assessment of adverse events in relation to medicinal products authorized for use in the EU.
2. Ensure the collection and analysis of accurate, up-to-date, and complete information on the safety of medicinal products.
3. Enhance the early detection of potential safety signals and the rapid assessment of their clinical significance.
4. Provide healthcare professionals, patients, and regulatory agencies with timely and relevant information on the safety of medicinal products.
5. Support the decision-making process for the authorization and ongoing safety monitoring of medicinal products in the EU.

Eudravigilance plays a critical role in the pharmacovigilance of medicinal products in the EU, helping to ensure the safe and effective use of these products and to protect public health.

You may be interested in the programs below: