• Centralized Procedure to see Simplified Submission Process, Says EMA

    The European Medicines Agency (EMA) has announced that it has simplified the process by which marketing authorization applications (MAAs) are submitted to the agency, reducing the number of applications that marketing authorization holders (MAHs) need to submit during the centralized procedure. The changes comes just as EU regulators are in the midst of implementing the pharmacovigilance legislation, an EU-wide set of requirements intended to make it easier to track and ...
  • EMA Announces Huge Overhaul of Operations, Processes

    The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced. In a statement released on its website on 19 December 2012, the agency said the overhaul will be "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations." A particular focus will be placed on how it supports the mission of its scientific committees-the Committee for Medicinal P...
  • EMA Appoints Leaders of Newly-Formed Pharmacovigilance Committee

    The European Medicines Agency (EMA) has announced the appointment of the chair and vice chair of its newest committee, the Pharmacovigilance Risk Assessment Committee (PRAC), which is set to oversee newly implemented pharmacovigilance measures in the EU. The PRAC was formed to replace the now-defunct Pharmacovigilance Working Party (PHVWP). In a July statement, EMA said the PHVWP had completed its original charge, which was in its possession since the agency's founding...