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 » FDA to Recognize GMP Inspections From Eight EU Countries

FDA to Recognize GMP Inspections From Eight EU Countries

November 3, 2017

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities  in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year.

FDA Commissioner Scott Gottlieb described the GMP partnerships, taking effect Nov. 1, as getting the “the greatest bang for our collective inspectional buck.”

“By partnering with these countries we can create greater efficiencies and better fulfill our public health goals, relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries,” Gottlieb said. Currently, the FDA is working to assess the capabilities of all 28 EU countries by July 2019.

In June, the European Commission determined that the FDA’s GMP inspections would be equivalent to the EU’s, to avoid duplication of drug inspections. Since then, the EMA has been deferring its work in the United States. In 2016, EU inspectors conducted 129 GMP inspections in the U.S.

The pact to amend the pharmaceutical annex to the 1998 mutual recognition agreement was settled upon in March, following three years of negotiations. The agreement also allows regulators to accept GMP documents from outside their territories.

View today's stories

Pharmaceuticals Inspections and Audits

Upcoming Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

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

  • BioVentrix gets Expanded Access Approval for Left Ventricle Support System

  • FDA Approves Stemline’s Orserdu for Several Forms of Breast Cancer

  • FDA Issues Update on LivaNova Recall of Blood Pumping System

  • EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis

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 or Share My Data
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing