Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

FDA, EMA Strengthen Pharmacovigilance Collaboration

Published: Thursday, February 20, 2014
Last Updated: Thursday, February 20, 2014
Bookmark and Share
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance topics.

Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

The FDA and the EMA have already set-up such clusters to discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children, blood-based products, among other topics. Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency are also involved in some of these clusters.

“The work of protecting the health and safety of the American people cannot be done in isolation,” says Janet Woodcock, Director, M.D., director of the FDA’s Center for Drug Evaluation and Research. “It is part of a larger collaborative global effort between the FDA and its international regulatory partners to ensure the health and safety of all our citizens.”

As part of the new cluster, discussions on shared pharmacovigilance issues will now take place between the agencies on a monthly basis by teleconference. This increased degree of interaction will allow the agencies to work swiftly in the area of the safety of medicines and to coordinate communication activities. The creation of this cluster is the latest step in the FDA’s and the EMA’s broader approach to expand and reinforce international collaboration.

“In an increasingly globalised pharmaceutical market, collaboration between medicines’ regulators is essential,” explains Guido Rasi, the EMA’s Executive Director. “Medicines’ regulators are inter-dependent: any action taken in one territory has repercussions on the rest of the world. International cooperation is a key area of work for the agency.”

This type of collaborative effort is important for ensuring the safety and quality of medicines distributed to consumers throughout the globe. The new cluster will help medicines’ regulators harmonize efforts to keep medicines safe, regardless of location.

Canadian and Japanese regulatory authorities will participate in the meetings of the cluster on pharmacovigilance as observers. The information exchange is covered by confidentiality arrangements between the FDA and the other participants.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,600+ scientific posters on ePosters
  • More Than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Advancing Precision Medicine by Enabling a Collaborative Informatics Community
The FDA is developing an informatics platform that will facilitate the sharing of expertise of knowledge in the field of precision medicine.
Wednesday, August 12, 2015
FDA Declares Trans Fatty Acids Unsafe for Consumption
TFAs are widely recognized as the most harmful fat with regard to causing cardiovascular disease (CVD).
Wednesday, July 15, 2015
FDA Seeks $4.9 billion to Implement the FDA Food Safety Modernization Act
FY 2016 request reflects a nine percent increase from FY 2015 budget, aims to improve the quality and safety of the medical products Americans use.
Monday, February 23, 2015
FDA Issues Additional Guidance For Outsourcing Facilities That Compound Sterile Human Drugs
Agency outlines details on registration, fees, and drug product reporting for outsourcing facilities.
Tuesday, November 25, 2014
FDA Rules Will See Calorie Counts on Menus
The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations.
Tuesday, November 25, 2014
FDA Food Safety Challenge
Challenge aims to spur new technologies for fighting foodborne illness.
Friday, September 26, 2014
FDA Allows Marketing of T2Candida
FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample.
Tuesday, September 23, 2014
FDA Issues Guidance on Use of Nanotechnology in Food Production
The three final guidances and one draft guidance provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Tuesday, July 01, 2014
FDA Proposes New Expedited Access Program for Medical Devices
New program would provide earlier access to high-risk medical devices that address unmet needs in the treatment or diagnosis of patients with serious conditions.
Tuesday, April 22, 2014
FDA Approves First Generic Versions of Antidepressant Drug Cymbalta
The U.S.FDA approved the first generic versions of Cymbalta), a prescription medicine used to treat depression and other conditions.
Monday, December 16, 2013
FDA Approves First Adjuvanted Vaccine for Prevention of H5N1 Avian Influenza
Vaccine to supplement National Stockpile, not intended for commercial availability.
Wednesday, November 27, 2013
FDA Takes Step to Help Ensure the Safety of Imported Food
Agency releases new proposed rules under FSMA for verifying foreign suppliers and accrediting third-party auditors.
Monday, July 29, 2013
FDA Approves Simponi to Treat Ulcerative Colitis
The U.S. FDA approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Monday, May 20, 2013
FDA Accepts Biogen Idec’s Biologics License Application
ELOCTATE™ has potential to provide long-lasting protection and markedly reduce treatment burden for patients.
Tuesday, May 14, 2013
FDA Proposes New Food Safety Standards for Foodborne Illness Prevention and Produce Safety
Public encouraged to comment on new proposals.
Monday, January 07, 2013
Scientific News
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Chromosomal Chaos
Penn study forms basis for future precision medicine approaches for Sezary syndrome
Enzyme Malfunction May be Why Binge Drinking Can Lead to Alcoholism
A new study in mice shows that restoring the synthesis of a key brain chemical tied to inhibiting addictive behavior may help prevent alcohol cravings following binge drinking.
Key to Natural Detoxifier’s Reactivity Discovered
Results have implications for health, drug design and chemical synthesis.
New Treatment for Obesity Developed
Researchers at the University of Liverpool, working with a global healthcare company, have helped develop a new treatment for obesity.
New Protein Found in Immune Cells
Immunobiologists from the University of Freiburg discover Kidins220/ARMS in B cells and demonstrate its functions.
Will Brain Palpation Soon Be Possible?
Researchers have developed non-invasive brain imaging technique which provides the same information as physical palpation.
Shaking Up the Foundations of Epigenetics
Researchers at the Centre for Genomic Regulation (CRG) and the University of Barcelona (UB) published a study that challenges some of the current beliefs about epigenetics.
Groundbreaking Computer Program Diagnoses Cancer in Two Days
Researchers have combined genetics with computer science and created a new diagnostic technology can with 85 per cent certainty identify the source of the disease and thus target treatment and, ultimately, improve the prognosis for the patient.
Michigan Researchers Use Raman Spectroscopy
inVia confocal Raman microscope used in the study of various childhood diseases.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos