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 » ANSM Aims for Better Surveillance, Enhanced Training

ANSM Aims for Better Surveillance, Enhanced Training

July 31, 2015

French health officials have promised to beef up surveillance of medical devices as part of a multi-year action plan released late last month.

Dominique Martin, director general of the Agence nationale de sécurité du medicament et des produits de santé, signed off on the plan that details four specific strategies to enhance health by 2018. These strategies are guaranteeing the safety of products throughout their lifecycle; promote rapid access to health products; encourage better communications with stakeholders; and make the agency more efficient and modernized.

The report, titled Contract D’Objectifs et de Performance, examines 12 targets and 22 specific actions the ANSM intends to take over this time period. The agency intends to focus on improving products by analyzing medical device data, monitoring clinical trial applications, examining advertising and obtaining information from other European competent authorities. It has promised to strengthen its inspection capabilities both in France and other countries.

In addition it will work with institutional partners to develop a common policy to exchange information on surveillance of products relevant to the agency. It will also ensure appropriate communications with healthcare professionals about the agency’s mission.

The agency is stepping up efforts to optimize the review of medical products. As part of that plan, it will work to train reviewers to ensure they have the appropriate scientific expertise and encourage employees to update their skills to review the dossiers of increasingly complex products.

To read the full report in French, visit http://www.fdanews.com/08-03-15-france-report.pdf.
— Elizabeth Hollis

Regulatory Affairs

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

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

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