FDA and EMA Collaborate on Pharmacovigilance - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA and EMA Collaborate on Pharmacovigilance


FDA and the European Medicines Agency (EMA) have set up a regular collaborative meeting (cluster) to discuss pharmacovigilance (medicine safety) topics, building on previous regular videoconferences between FDA and EMA and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee. The cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines, and discussions on shared pharmacovigilance issues will take place between the agencies on a monthly basis by teleconference. The increased interaction will allow the agencies to work swiftly on issues of safety and to coordinate communication activities. The creation of this cluster is the latest step in FDA’s and EMA’s broader approach to expand and reinforce international collaboration. FDA hopes that the new cluster will help drug regulators harmonize efforts to keep medicines safe, regardless of location.

“The work of protecting the health and safety of the American people cannot be done in isolation,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

 “In an increasingly globalized pharmaceutical market, collaboration between medicines’ regulators is essential,” explained Guido Rasi, the EMA’s executive director, in the press release. “Medicines’ regulators are interdependent: 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.”

Canadian and Japanese regulatory authorities will observe pharmacovigilance cluster meetings. The information exchange is covered by confidentiality arrangements between FDA and the other participants.

Source: FDA.gov

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy

Click here