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U.S. Department of Health and Human Services

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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 2018 Updates

Enhance collaboration and information sharing with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection: Lead work in the APEC RHSC (Regulatory Harmonization Steering Committee) to create and foster APEC Training Centers of Excellence (CoEs) for Regulatory Science, by continuing to conduct regional pilot programs and CoE training programs in FY 2018.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
Four Center of Excellence training programs were held from October – December 2017 in the areas of Biotherapeutics, Good Registration Management, Pharmacovigilance and Medical Device Vigilance. Several more pilot programs and CoE training programs are planned for early 2018, as well as a face-to-face meeting of the RHSC Steering Committee in February. Work continues on creating a new priority work area for medical devices. Quarter 1
Completed Quarter 1
The first face-to-face meeting of 2018 was held in February, during which 2 new Pilot CoE programs in Advanced Therapies and Biotherapeutics programs were endorsed. A new priority work area for Medical Devices (which FDA co-leads with Korea and Japan) was approved. Plans for 12 CoE training programs to be conducted in CY 2018 are underway, including a basic level workshop in Korea on global supply chain integrity, being led by FDA. Quarter 2
Completed Quarter 2
FDA is continuing to identify topics and respective CoE training champions for the newly endorsed medical device initiative, and in the planning of a basic level workshop in Korea on global supply chain integrity.  A CoE training program  on multiregional clinical trials and good clinical practices was hosted by Harvard University in April.  The RHSC is actively planning for its next face-to-face meeting in August.  At least 12 CoE programs are planned for calendar year 2018.  Quarter 3
Completed Quarter 3
The last face-to-face RHSC meeting of 2018 was held in August during which Harvard was named as a new Center of Excellence for regulatory training on multiregional clinical trials and good clinical practices. Progress was reported in all 7 work streams, including the new medical device area. Two new Priority Work Areas (PWAs) were proposed for consideration next year: Pharmaceutical Quality and electronic standards. Quarter 4
Completed Quarter 4

FY 2017 Updates

Enhance collaboration and information sharing with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection: Lead work in the APEC RHSC (Regulatory Harmonization Steering Committee) to create APEC Training Centers of Excellence (CoEs) for Regulatory Science, by continuing to conduct regional pilot programs in efforts to formalize full-fledged CoEs in FY 2017.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
FDA co-chairs the APEC RHSC (Regulatory Harmonization Steering Committee) which is working to create APEC Training Centers of Excellence (CoE) for Regulatory Science. Seven regional pilot programs have been conducted thus far, with seven more pilots planned for 2017. Topic areas include multiregional clinical trials, biotherapeutics, global supply chain integrity, pharmacovigilance and medical device vigilance, cell and tissue based therapies, and good registration management. Hosting a pilot program is a pre-requisite for institutions to be considered for endorsement as a formal APEC CoE. Several applications to become a full-fledged APEC CoE are expected in FY 2017. Quarter 1
Completed Quarter 1
During their meeting in February 2017, the RHSC (Regulatory Harmonization Steering Committee) endorsed the first 6 formal APEC Training Centers of Excellence (CoE) at these institutions: Northeastern University (Biotherapeutics); Peking University (MRCT/GCP); Pharmaceutical and Medical Device Agency (PMDA), Japan (MRCT/GCP); Duke-NUS Singapore (MRCT/GCP); RAPS cooperating with Taiwan FDA (Good Registration Management); and PMDA (Pharmacovigilance and Medical Device Vigilance). In addition, several CoE Pilot Programs are slated for 2017. A new category of APEC training workshops called "Pre CoE Pilots" were endorsed that would provide training on the fundamentals of a particular topic, and be targeted to a particular geographic region within APEC. The first one will be held in the Latin American region in November on Biotherapeutics. Quarter 2
Completed Quarter 2
Preparations are being made for the next face-to-face RHSC (Regulatory Harmonization Steering Committee) meeting in mid-August, 2017. It is anticipated that several institutions will submit applications to become an Asia-Pacific Economic Cooperation (APEC) Center of Excellence (CoE), which will be considered at the August meeting. During Quarter 3, CoE Pilot Programs were conducted by the University of Tennessee on Global Supply Chain Integrity, and by Mexico’s regulatory authority, COFEPRIS, on Good Registration Management. A number of additional Pilot Programs are currently being planned for the remainder of 2017. Quarter 3
Completed Quarter 3
During the last meeting in August 2017, 3 additional APEC Training Centers of Excellence (CoEs) were endorsed: University of Tennessee Health Science Center (UTHSC) and the US Pharmacopeia (USP) in the area of global supply chain integrity, and the Korean Institute for Drug Safety and Risk Management (KIDS) for pharmacovigilance.  Several additional Pilot CoE programs are currently being planned for late 2017 and early 2018, including programs in a new priority work area for medical devices. Quarter 4
Completed Quarter 4

FY 2016 Updates

Enhance collaboration and information sharing with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection: Engage both at the strategic and technical levels (Management Committee and Expert Working Groups) within the International Pharmaceutical Regulators Forum.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
International Pharmaceutical Regulators Forum (IPRF) Cell Therapy Working Group (17 regulatory authorities) held telecons on best practices; specific discussions on 1) factors considered re nature/ duration of patient follow-up after receiving CT product; 2) manufacturing standards. IPRF Gene Therapy Working Group (12 regulatory authorities) finalized journal article for ASGCT Journal Molecular Therapy (Methods and Clinical Development), article summarizes meetings held in June 2015 on international expectations of biodistribution. IPRF Management Committee met Dec 7-8, 2015 (undertaking 5-year strategic development process, expect completion June 2016). Quarter 1
Completed Quarter 1
Teleconferences to discuss best practices continued for the International Pharmaceutical Regulators Forum (IPRF) Cell Therapy and Gene Therapy Working Groups.  In a follow-up discussion from the Jacksonville Dec 2015 IPRF Management Committee meeting, FDA has been the point of contact for fielding technical questions related to the Identification of Medicinal Products (IDMP).  FDA will propose that a new IPRF working group on IDMP be created at the next Management Committee meeting. Quarter 2
Completed Quarter 2
Teleconferences to discuss best practices continued for the International Pharmaceutical Regulators Forum (IPRF) Cell Therapy and Gene Therapy Working Groups. Both groups are working on new topics for IPRF Management Committee (MC) consideration, and have proposed a pathway for bringing certain IPRF topics to International Council for Harmonisation (ICH) for consideration.  FDA has been serving as the point of contact for establishing a new IPRF working group on IDMP (Identification of Medicinal Products). Quarter 3
Completed Quarter 3
The International Pharmaceutical Regulators Forum (IPRF) Management Committee (MC) currently reviewing Cell Therapy and Gene Therapy Working Groups' proposed pathway for bringing certain IPRF topics to the International Council for Harmonisation (ICH) for consideration, as part of a larger long-term IPRF strategy. Conclusion determined at next face-to-face IPRF meeting November 2016. Regarding Identification of Medicinal Products (IDMP) work group proposal, the MC requested revised Terms of Reference, which has been circulated for comment, and will be endorsed by MC intersessionally, before the next meeting in November 2016. Quarter 4
Completed Quarter 4

FY 2015 Updates

Enhance collaboration and information sharing with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection: CBER staff participation in World Health Organization (WHO) consultations/meetings. Number of WHO Consultations in which CBER staff participated and contributed expertise in FY'15.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
Number of WHO Consultations in which CBER staff participated and contributed expertise in Q1 FY'15: 9 Quarter 1
Completed Quarter 1
Number of WHO Consultations in which CBER staff participated and contributed expertise in Q2 FY'15: 7 Quarter 2
Completed Quarter 2
Number of WHO Consultations in which CBER staff participated and contributed expertise in Q2 FY'15: 6 Quarter 3
Completed Quarter 3
Number of WHO Consultations in which CBER staff participated and contributed expertise in Q4 FY'15: 7 Quarter 4
Completed Quarter 4

FY 2014 Updates

Enhance collaboration and information sharing with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection: partner with CDRH to host two International Medical Device Regulators Forum Meetings by September 30, 2014.

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

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

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.

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