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  1. Generic Drugs

Global Generic Drug Affairs

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Global Generics Insights

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FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements. The role of the Global Generic Drug Affairs Team is to lead, coordinate, and manage OGD’s international activities in collaboration with FDA Centers and Offices to advance the overall mission of OGD and FDA.

OGD’s International Activities and Engagements

Generic Drug Cluster Adds Member Agency

The FDA led forum, the Generic Drug Cluster, established for the world’s leading regulatory agencies to address generic drug development globally, has added a new regulatory agency to its roster– Australia’s Therapeutic Goods Administration (TGA). This makes a total of seven regulatory agencies participating in the Cluster. The Generic Drug Cluster aims to increase scientific alignment among leading generic drug regulatory agencies by fulfilling the following objectives:

  • Offering a confidential forum for exchange of discussion on policies in development, including draft guidances for industry, and the scientific basis for decisions on those policies. The regulatory agencies included in the cluster have Confidentiality Commitments and the Generic Drug Cluster does not release information regarding the topics discussed in the cluster. Additionally, no guidance information is released outside the scope of the confidentiality commitment governing the cluster.
  • Achieving a common understanding of each agency’s regulatory requirements for approval and current thinking on topics related to generic drug development through information sharing on approval requirements and recommendations conveyed in guidance documents.
  • Provision of a forum for a discussion of general and product/class-related scientific review issues and fostering alignment in approaches to scientific evaluation whenever possible.
  • Addressing long-term safety issues to ensure a global safety net for generic drugs through confidential sharing of reports.

The OGD Global Generic Drug Affairs team collaborates with strategic partners within and outside FDA to establish internationally-focused programs that promote and protect the American public health. In collaboration with industry, international regulatory agencies, the scientific community, and the public, OGD’s global affairs activities encompass harmonization on scientific and technical recommendations for generic drugs under FDA’s Center for Drug Evaluation and Research (CDER) international harmonization initiatives, regulatory strengthening and reliance, partnerships and information sharing, and setting international standards. Recent collaborations include:

Overview of Generic Drug Global Program



Information and Resources

The links to resources below are intended to explain the generic drug program in the U.S. and provide navigational tools for foreign counterparts and information that assists industry in the development of generic drugs and their submission of abbreviated new drug applications (ANDAs).

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