In addition to working with U.S. government and non-government partners, FDA works with a variety of international partners to foster the development and availability of medical countermeasures, or MCMs. Examples include, but are not limited to, the following.
Confidentiality commitments and international arrangements
Agreements between FDA and various international counterparts support information-sharing and collaboration and have better prepared the international regulatory community to respond to current and future public health emergencies. These agreements include international confidentiality commitments with international regulatory authorities and the World Health Organization (WHO) to support current and future public health emergencies.
Global Health Security Agenda
Through a growing multisectoral partnership of international organizations, non-governmental stakeholders, and more than 50 countries, the HHS Global Health Security Agenda (GHSA) is accelerating efforts to build countries’ capacity to prevent, detect, and respond to infectious diseases and achieve the core capacities required by the International Health Regulations (IHR).” For more about JEE efforts, see from HHS, U.S. Health Security National Action Plan: Strengthening Implementation of the International Health Regulations.
WHO R&D Blueprint
The World Health Organization (WHO) R&D Blueprint is a global strategy and preparedness plan intended to allow the rapid activation of research and development activities during epidemics. Its aim is to fast-track the availability of effective tests, vaccines and medicines that can be used to save lives and avert large-scale crisis.
Coalition for Epidemic Preparedness Innovations (CEPI)
CEPI is an innovative partnership between public, private, philanthropic, and civil organizations that aims to stop future epidemics by developing new vaccines.
Global Research Collaboration for Infectious Diseases Preparedness (GloPID-R)
GloPID-R is the only network of major research funding organizations working on a global scale. Together, these organizations strive to facilitate an effective research response within 48 hours of an infectious disease outbreak.
International Coalition of Medicines Regulatory Authorities (ICMRA)
The ICMRA is comprised of medicines regulators worldwide who have committed to enhanced cooperation with the WHO and among regulatory agencies to encourage submission of regulatory dossiers and evaluation of the submitted information on potential new medicines to address emerging public health threats.
Foundation for Innovative New Diagnostics (FIND)
A WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation, FIND is a global nonprofit organization driving innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations.
Want to partner with FDA on MCM-related initiatives? Contact AskMCMi@fda.hhs.gov.
Related links from around FDA
- International Arrangements
- Mutual Recognition Agreement (MRA)
- International Activities (CBER)
- WHO Engagements (CBER)