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U.S. Department of Health and Human Services

About FDA

FDA-EMA Tracking Database

Description: Database of Information Sharing (tracking) with the European Medicines Agency (EMA) - Track interactions (meetings, conference calls, exchange of confidential material) between FDA and EMA to better analyze the type of information exchanged and the frequency by several parameters (e.g., pediatrics, oncology, parallel scientific advice, orphan drugs, veterinary medicines, etc.). The database will allow us to refine the interactions to make them more efficient and timely, thereby increasing the public health impact of the exchanges.

OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Conduct initial brainstorming and OIP Europe/EMA teleconferences to determine the needs of a searchable database

1/25/2010

Completed 1/25/2010

B. Compose first draft of Excel spreadsheet database

2/28/2010

Completed 2/28/2010

C. Present OIP/EMA agreed draft Excel spreadsheet to OIP and EMA management and FDA Center international liaison staff for comment and input, as required

Begin 3/4/2010

Completed 3/31/2010

D. Implement draft Excel spreadsheet database for tracking of FDA/EMA information exchanges

5/1/2010

Completed 4/1/2010

E. Identify best practices for information archives from established FDA-EMA Clusters

6/1/2010

Completed 6/1/2010

F. Complete full implementation of readily searchable database of information sharing between FDA/Europe Office and European counterparts, for human and veterinary drugs and biologics, devices, foods, tobacco, and combination products (1)

N/A

N/A N/A

Footnotes

  • (1) Milestone was not completed while this project was tracked in FDA-TRACK.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.