Saturday 29 July 2017

Office of International Programs

FDA’s Office of International Programs (OIP) works with governments, industry and academia in foreign countries, as well as with multilateral organizations, to help assure that food and medical products exported to the United States meet U.S. standards. Today, with 300,000 foreign facilities from more than 150 countries exporting FDA-regulated products to the United States, FDA works beyond U.S. borders to ensure that products coming into the United States are safe and effective.

Through OIP’s foreign posts, and in close cooperation with FDA Centers and the Office of Regulatory Affairs (ORA), OIP assists in FDA decisions and actions by:
  • Obtaining information on the regulatory environment within a country or sub-region, including regulatory authority’s remit, scope and capacity, the robustness and role of industry, the intersections between a national regulatory authority and the industry it regulates, and information on emerging actions and trends that could impact FDA’s regulation of product;

  • Conducting inspections and investigations in foreign countries, and

  • With clear benefit to and support of FDA’s mission, identify, catalyze and/or facilitate targeted engagements with relevant stakeholders in a country or sub-region in areas of common interest and mutual benefit.


OIP helps to assure the safety of imported products in other ways, for example through:
  • Informing foreign industry about U.S. requirements;

  • Catalyzing stronger capabilities of foreign regulatory authorities;

  • Sharing information with FDA’s Centers and Offices about the international context in which FDA operates.

OIP Activities


OIP Strategy Map (PDF - 74KB)
OIP Strategy Map (Accessible Text Version)
FDA Globalization
Imports and Exports
International Arrangements
International Programs and Activities
Office of Global Regulatory Operations and Policy (GO)
President's Emergency Plan for AIDS Relief (PEPFAR)


Source: http://docphy.com/business-industry/business/office-international-programs.html

No comments:

Post a Comment