We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » EMEA REPORTS INCREASE IN DRUG SAFETY REPORTS

EMEA REPORTS INCREASE IN DRUG SAFETY REPORTS

April 25, 2006

The number of drug safety reports filed with the European Medicines Agency (EMEA) increased dramatically last year with the implementation of mandatory electronic filing, according to the EMEA's annual report.

The EMEA said it received 42,120 adverse drug reports in 2005, compared to 18,174 in 2004 and 15,017 in 2003.

As of November 2005, drug developers and clinical trial sponsors were required to file drug safety reports into the EudraVigilance database, the EMEA said.

Health officials and companies with approved drugs must also electronically file post-marketing authorization reports into EudraVigilance. These stakeholders sent a total of 144,786 individual case safety reports (ICSRs) originating from within and outside the European Union, the report said. Eighty percent of the more than 42,000 adverse drug reaction reports received in 2005 were from these postmarket reports.

In addition, 67 sponsors of clinical trials within the European Economic Area reported a total of 34,352 suspected unexpected serious adverse reactions into EudraVigilance.

Stakeholders also filed 32,842 retroactive electronic filings, according to the EMEA. At the end of 2005, EudraVigilance contained 524,782 ICSRs, corresponding to 203,844 individual cases.

The report can be found at: http://www.emea.eu.int/pdfs/general/direct/emeaar/AnnualReport2005.pdf (http://www.emea.eu.int/pdfs/general/direct/emeaar/AnnualReport2005.pdf).

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • AstraZeneca

    AstraZeneca Withdraws Imfinzi’s Bladder Cancer Indication

  • CE mark

    Cue Health’s COVID-19 Test Receives CE Mark

  • Sanofi-Regeneron_Logos.png

    Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

  • PerkinElmer logo

    PerkinElmer’s Rapid Point-of-Care COVID-19 Test Cleared in Europe

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing