EMA Rolls Out Monthly Time Slots To Stagger Registration To Revamped EudraVigilance Database
Executive Summary
The European Medicines Agency has drawn up a list of approximately 3,000 marketing authorization holders that need to be registered to the modernized pharmacovigilance database by November. The agency will tackle the list in alphabetical order, undertaking around 600 registrations per month starting June 1. Companies that fail to apply within the designated monthly slot will be put at the end of the queue, which may delay their access to the database.
You may also be interested in...
New EudraVigilance System To Usher In Simplified Reporting of ADRs From Nov. 22
The European Medicines Agency is asking drug companies and EU national competent authorities to prepare for the late November launch of the new EU pharmacovigilance database, which will have enhanced functionalities for reporting and analysing suspected adverse reactions.
EMA To Address Industry Concerns in Revised Signal Management Guideline
The European Medicines Agency is examining the “constructive and pragmatic” feedback it has received on its revised guideline on safety signal detection, which aims to help companies fulfil their new legal obligation to monitor EudraVigilance data and report validated signals within strict timelines.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.