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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » European Regulators Nudge Sponsors to Publish Trial Results in EU Database

European Regulators Nudge Sponsors to Publish Trial Results in EU Database

July 15, 2019

Europe’s regulators reminded clinical trial sponsors to  submit their trial results to the EU’s EudraCT clinical trials database, to comply with regulations in July 2014.

The European Commission, the European Medicines Agency and the Heads of Medicines Agencies co-signed the letter reminding EU clinical trial sponsors that they are required to summarize the results of their trials for public viewing in the database.

As of 2019, the database included 57,687 clinical trials, of which 27,093 were completed. Out of the completed trials, 18,432 should have had results posted. Sponsors complied with requirements for approximately 12,577 trials, but results were still lacking for 5,855.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Thermo Fisher Scientific Gets FDA Premarket Approval for Companion Diagnostic

  • MHRA Grants Conditional Authorization to Moderna’s Bivalent COVID-19 Booster Vaccine

  • Organogenesis Gets 510(k) Clearance to Expand PuraPly Portfolio

  • FDA Grants Priority Review to sNDA for Lynparza

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 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing