EudraVigilancea

EudraVigilance is a European Union (EU) database and reporting system for suspected adverse reactions to medicines. It is managed by the European Medicines Agency (EMA) and is part of the EU's regulatory framework for medicines. The system is designed to collect, evaluate, and disseminate information on suspected adverse drug reactions, which is crucial for ensuring the safety of medicines in the EU.

EudraVigilance operates through a network of national reporting centers in each EU member state. These centers are responsible for receiving reports of suspected adverse reactions from healthcare professionals, patients, and other sources. The reports are then submitted to the EMA, which centralizes and processes the data.

The primary goal of EudraVigilance is to detect and assess the safety of medicines, identify potential risks, and contribute to the continuous improvement of pharmaceutical products. The system plays a vital role in the post-marketing surveillance of medicines, which is essential for monitoring their safety and efficacy over time.

EudraVigilance also facilitates the exchange of information between regulatory authorities, pharmaceutical companies, and healthcare professionals. This collaboration helps in the timely detection of adverse reactions, the development of safety measures, and the dissemination of important safety information to the public.

In summary, EudraVigilance is a critical component of the EU's regulatory framework for medicines, focusing on the detection, evaluation, and dissemination of information on suspected adverse drug reactions to ensure the safety of medicines in the EU.