Food and Drug Administration (FDA)
FDA approvals apply to US, but affect research globally
The US Food and Drug Administration (FDA) maintains a limited but special role in the research and development (R&D) of health technologies for the developing world. The agency’s principal function—formal approval to market and distribute new or improved drugs, vaccines, devices, and other materials—applies only to the domestic market.
Nevertheless, FDA’s approval methods have consequences for global health technology R&D. The approval process, for example, starts at the beginning of human testing of a product and affects planning and scheduling of R&D activities.
To help improve health in developing countries, proposals may be put forward to expand FDA authority. In the long term, working with the FDA may have benefits for approvals in countries hard hit by infectious diseases.
Acknowledging global R&D
FDA’s domestic medical product approval regulations incorporate features that recognize the global nature of R&D. FDA regulations and procedures:
- Allow the use of foreign data to support the domestic approval of a technology.
- Establish a coordinated system of inspection and verification that foreign authorities must satisfy to ensure that products are safe and effective.
- Recognize international community standards for collecting data needed for approval.
- Set US standards for protection of research subjects.
FDA in global health technology
FDA’s involvement in global health technology may one day expand to support accelerated R&D and introduction outside the United States. Currently, FDA’s Office of International Programs is devoted principally to international issues as they affect importation of products to the United States. The office:
- Participates in discussions with approving authorities in other countries to compare and often harmonize the approval regulations used by each authority.
- Consults on capacity issues for inspecting and approving R&D when products are imported.
- Oversees international FDA offices that work directly with foreign counterparts.
FDA has entered into formal cooperative agreements and memoranda of understanding with individual countries for these functions. The arrangements relate either to food safety or to medical products produced by developed countries for US import.
For more information on the above data, please see:
US Food and Drug Administration.
FDA regulations and procedures database.
FDA Office of International Programs.
FDA Office of International Programs, International Arrangements.
