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U.S. Department of Health and Human Services

About FDA

Enhance collaboration with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection

Description: The development of vaccines for global public health threats requires global regulatory cooperation in order to improve efficiency and harmony. Using common approaches to evaluate the vaccine safety and effectiveness will speed the development of vaccines and improve access to products required to protect public health. This measure demonstrates CBER’s commitment to improve coordination with foreign regulatory authorities and enhance access to vaccine products required to protect global public health.

FY 2013 Updates

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

Participated as an World Health Organization (WHO) Assessment Team Member and provided expert advice to the National Regulatory Authority in India.

Quarter 1

Completed Quarter 1

No Updates this Quarter

Quarter 2

Completed Quarter 2

Participated in multiple teleconferences with the WHO, Health Canada and European Medicine Agency to discuss influenza virus H7N9 preparedness (April 25 -June 13, 2013). Participated and provided expert advice in the WHO-UNAIDS Vaccine Advisory Committee Meeting (June 14-15, 2013).

Quarter 3

Completed Quarter 3

Participated in a quadrilateral teleconference with Health Canada, EMA, and the World Health Organization (WHO) to discuss H7N9 preparedness activities (September 12, 2013). Activity enhanced collaboration concerning the global pandemic response and preparedness; Provided expert review and comment on six WHO documents that provided information and guidelines related to the characterization, safety and efficacy of vaccines and considered by the WHO Expert Committee on Biological Standardization (ECBS) meeting (September 2013). Activity enhanced collaboration concerning the development of international biological standards for vaccines; Participated as a subject matter expert for the International Agency for Research on Cancer (IARC)/National Cancer Institute (NCI) co-sponsored meeting entitled, “Endpoints for Prophylactic HPV Trials" in Lyon, France (September 23-24, 2013). Activity enhanced global collaboration concerning the evaluation of related vaccines.

Quarter 4

Completed Quarter 4

FY 2014 Updates

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

Key members of U.S. host team for the 2014 IMDRF meetings, providing expert collaborative advice on planning,contracting and organization of the meetings. In Q1, the team completed meeting goals, facility contract, event planning, and industry collaborations.

Quarter 1

Completed Quarter 1

FDA CDRH chaired the IMDRF 3-day meeting in San Francisco, CA on March 25-27, 2014. The IMDRF Management Committee includes regulatory members from 8 countries, as well as representatives from WHO, APEC and AWHP. One session of the meeting also included presentations given by invited observers from approximately 12 organizations/countries. On March 26, 2014, the public Stakeholders Meeting had over 170 participants representing regulators, industry, healthcare professionals, patients and researchers. Outcomes of the meeting can be found at www.imdrf.org/meetings/meetings.asp#historic.

Quarter 2

Completed Quarter 2

The U.S. is the host team for the 2014 IMDFR meeting. In Q3, the team completed the meeting and planning goals for the September 2014 conference which included: completing the facility contract, finalizing the event management plans, and industry collaboration.

Quarter 3

Completed Quarter 3

FDA CDRH chaired the sixth IMDRF meeting in Washington DC during the week of September 15-19,2014, which included the IMDRF Management Committee Meeting with Invited Observers, public IMDRF Stakeholders Meeting, and the Management Committee wrap-up session for outcomes. The week's activities also included: Public Meetings: International Standards Meeting sponsored by DITTA; FDA Informational Session; Global Harmonization Summit sponsored by Advamed; and Harmonization by Doing Think Tank Meeting sponsored by MHLW/PMDA and FDA. The Pan American Health Organization (PAHO) also met to discuss work items. Each day of meetings held over 150 participants, representing regulators, industry, public health organizations, healthcare professionals, patients and researchers. Outcomes of the public IMDRF Stakeholders Meeting will be posted at www.imdrf.org/Meetings

Quarter 4

Completed Quarter 4

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.