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  • Regulatory NewsRegulatory News

    EMA Makes Final Preparations Ahead of New EudraVigilance Launch

    With the 22 November launch date for its revamped EudraVigilance system rapidly approaching, the European Medicines Agency (EMA) on Wednesday provided some last minute updates on what to expect during the transition to the new system. New EudraVigilance System The new system, developed in response to changes brought on by the EU's pharmacovigilance legislation that went into effect in 2012, promises to improve adverse event reporting and safety monitoring. Specifical...
  • Regulatory NewsRegulatory News

    EMA Offers New EudraVigilance Checklist for Sponsors, MAHs

    The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017. The checklist features general testing instructions and easy-to-follow steps to assist sponsors and MAHs in the transition. In addition, EMA notes that the ICH E2B(R3) Implementation Guide and the EU ICSR Implementation...
  • Regulatory NewsRegulatory News

    EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events

    The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events. In the lead up to the launch of the new EudraVigilance system, EMA says national competent authorities, marketing authorization holders (MAHs) and sponsors of clinical trials have to make  final preparations  to ensure that their processes and IT infrastructures can work with the new...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments (20 April 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Reveals Talks With FDA About Joint Accelerated Assessment Activities The European Medicines Agency (EMA) has revealed it is talking to its counterpart in the US about joint activities covering accelerated assessments. The subject is one of several areas in which EMA and the US Food and Drug Administration (FDA) are considering stepping up their cooperation. EMA ha...
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    European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Trade Groups Propose Criteria for Deciding New Home of EMA European biopharma trade groups have jointly set out criteria for deciding on the new home of the European Medicines Agency (EMA). The three trade groups detailed their desire for the selection process to consider six essential criteria in a letter to a high-ranking health official at the European Commission...
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    EMA Releases List of Medical Events for Pharmacovigilance Monitoring

    The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events. EMA says the list will assist it and other regulators to prioritize the review of suspected adverse events that "deserve special attention, irrespective of statistical criteria used to prioritize safety reviews," and contribute to the agency's day-to-day pharmacovigil...
  • Regulatory NewsRegulatory News

    EMA Begins Pharmacovigilance Training Courses

    The European Medicines Agency (EMA) this week began running a series of pharmacovigilance training sessions to help companies and regulators meet their obligations when using EudraVigilance, a centralized European database of suspected adverse reactions to medicines in the European Economic Area (EEA). At least one user from each national competent authority, marketing-authorization holder or sponsor of clinical trials in the EEA should complete the training to ensure th...
  • Regulatory NewsRegulatory News

    EMA Explains Centralized Product Database, Talks Future Changes

    The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA). In the document, the agency discusses the current status of its eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and talks about planned changes through 2016. Pharmacovigilance in the EU Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. ...
  • Regulatory NewsRegulatory News

    EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

    In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse. Background Regulators use reports based on this literature differently. In most regions...
  • Countries Responsible for EU-wide Safety Monitoring Announced

    The European Medicines Agency (EMA) published on 5 October 2012 the first list of EU member states responsible for monitoring the safety of specific active substances across the EU.  In effect, each listed country will be responsible for monitoring specific medicinal products that have been approved for marketing in more than one EU member state through either the national, mutual recognition or decentralized procedures.  The monitoring data that each coun...
  • New EMA-Run Website Looks to Boost Adverse Event Reporting Transparency

    The European Medicines Agency (EMA) is looking to enhance its transparency measures surrounding the receipt and publication of adverse event reports for all medicines authorized in the European Economic Area (EEA) through a brand-new website. The website, www.ADRreports.eu , is linked up with EMA's EudraVigilance adverse event reporting database and already contains information on more than 650 medicines authorized through the centralized procedure. Each report on the w...
  • EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations

    A new course launched by the European Medicines Agency (EMA) aims to assist Marketing Authorization Holders (MAHs) comply with new Article 57(2) EudraVigilance regulations on the submission of information on medicines. The six-part course covers the basics of the EudraVigilance system, the regulatory underpinnings of the system, which definitions are used in the system, the submission of EudraVigilance Product Report Messages and how to enter data. Successful completion...