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

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

Join For Free

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 3,000+ scientific posters on ePosters
  • More Than 4,500+ 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 TechnologyNetworks.com 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

US Bans Three Food Packaging Chemicals
New ban includes three specific perfluoroalkyl ethyl containing food-contact substances (FCSs.
Friday, January 08, 2016
FDA Awards Breakthrough Therapy Designation to Boehringer’s Lung Cancer Candidate
Boehringer Ingelheim Pharmaceuticals has scored FDA breakthrough therapy designation for its candidate to treat patients with T790M mutation-positive non-small cell lung cancer.
Wednesday, January 06, 2016
FDA OK’s AquAdvantage Salmon
After an exhaustive and rigorous scientific review, FDA has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious.
Monday, November 23, 2015
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
Scientific News
The Rise of 3D Cell Culture and in vitro Model Systems for Drug Discovery and Toxicology
An overview of the current technology and the challenges and benefits over 2D cell culture models plus some of the latest advances relating to human health research.
Scientists Find Evidence That Cancer Can Arise Changes
Researchers at Rockefeller University have found a mutation that affects the proteins that package DNA without changing the DNA itself can cause a rare form of cancer.
Immune Cells Remember Their First Meal
Scientists at the University of Bristol have identified the trigger for immune cells' inflammatory response – a discovery that may pave the way for new treatments for many human diseases.
A New Platform for Discovering Antibiotics
Harvard chemists hope to shorten time, difficulty in measuring their effectiveness, potential.
Biosensor Detects Molecules Linked to Cancer, Alzheimer's and Parkinson's
Novel biosensor has been proven capable of detecting molecules associated with neurodegenerative diseases and some types of cancer.
Gene That Lowers Heart Attack Risk Identified
Individuals with a rare twelve-letter deletion from a gene on chromosome 17 have significantly reduced non-HDL cholesterol levels and a 35% lower than average risk of heart disease.
Non-Toxic Approach to Treating Variety of Cancers
A team of researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine recently discovered a novel, non-toxic approach to treating a wide variety of cancers.
"Sunscreen" Gene May Guard Against Melanoma
USC-led study reveals that melanoma patients with deficient or mutant copies of the gene are less protected from harmful ultraviolet rays.
Real-Time Imaging of Embryo Development Could Pave the Way
Researchers at IMCB have developed advanced microscopy technologies to monitor embryo development for more effective human reproduction therapies.
Testing Non-Breast/Ovarian Cancer Genes
Researchers have found that expanding gene panel beyond breast/ovarian cancer genes in these patients does not add any clinical benefit. Instead, testing has produced more questions than answers.
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!