If you’re in the pharmaceutical industry, you know how crucial pharmacovigilance is for ensuring drug safety and compliance.
EudraVigilance is the European system designed to manage and analyze information on the safety of medicines. It's an essential tool for monitoring adverse drug reactions (ADRs) and safeguarding public health across the European Economic Area (EEA).
What is Eudravigilance?
Eudravigilance is a centralized database maintained by the European Medicines Agency (EMA) since December 2001. Its primary objective is to facilitate the collection, management, and analysis of information on suspected adverse reactions to medicines authorized or being studied in clinical trials in the EEA. By monitoring and evaluating this data, Eudravigilance aims to detect any potential safety issues with medicinal products early, ensuring swift action can be taken to protect public health. EudraVigilance facilitates the electronic exchange of individual case safety reports (ICSRs) between EMA, national comptetente authorities (NCAs), Marketing Authorisation Holders (MAHs) and sponsors of clinical tirals int the EEA, promoting better product information for medicines authorized in the EEA.
Electronic reporting of suspected adverse drug reactions is obligatory for Marketing Authorisation Holders and sponsors of clinical trials.
Key Components of Eudravigilance
To effectively manage the flow of safety data, EudraVigilance utilizes several key components. Here you can find two of them:
Data submission and collection
- EudraVigilance Gateway (EV Gateway): This is a hub that facilitates the transfer of safety reports (Individual Case Safety Reports or ICSRs) and other regulatory documents to the Eudravigilance system in a fully automated and secure way. Companies and sponsors are responsible for installing and operating software that is suitable for the successful transmission of encrypted and digitally signed safety and acknowledgement messages.
- EudraVigilance Web reporting Application (EVWEB): This is the web interface that allows organizations without an automated local gateway solution to send and receive safety and acknowledgment messages securely via an Internet browser to the Eudravigilance database. Through EVWEB, users (also known as “Webtraders”) can create, send and view ICSRs and safety and acknowledgement messages. EVWEB also enables users to perform queries.
Document Updates
Recently, some key documents have been updated, which could impact your compliance processes:
- Eudravigilance Form A (appointment of a “Responsible Person for EudraVigilance” (RP) by a sponsor organization).
- New organization First User QPPV/RP or change of EU QPPV/RP
- Eudravigilance Registration (registration process with EMA for Marketing Authorisation Holders (MAHs), Commercial and Non-commercial Sponsors, and National Competent Authorities (NCAs), including the assignment of the role of EU Qualified Person for Pharmacovigilance (EU QPPV)/Responsible Person (RP)).
Navigating these updates and ensuring your team is up-to-date can be daunting. But you don't have to go it alone. Our pharmacovigilance services are here to help pharmaceutical companies like yours stay compliant and focused on what you do best – developing life-saving drugs.
Let's connect and explore how we can support your pharmacovigilance needs with expert guidance and tailored solutions. Reach out today, and let's ensure your EudraVigilance processes are robust and up-to-date!
Don’t hesitate to visit our website at https://www.axeregel.com for more information.
Links:
- EudraVigilance: how to register
- EudraVigilance registration documents (16/05/2024, PDF document)
- EudraVigilance Form A (16/05/2024, WORD document)
- New Organization First User QPPV/RP or Change of EU QPPV/RP (15/05/2024, PDF document)