Global Generic Drug Affairs

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 About The Generic Drug Cluster The Generic Drug Cluster, led by FDA, celebrated its 3-year anniversary (see article above) in June 2024 and continues to be a forum for the world’s leading regulatory agencies to address generic drug development globally. The Generic Drug Cluster Objectives The Generic Drug Cluster aims to increase scientific alignment among leading generic 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 U.S. Food and Drug Administration and Health Canada collaborate on generic drug information sharing initiative: Notice The U.S. Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) and Health Canada's (HC) Pharmaceutical Drugs Directorate have created a program to support the establishment of a Request for Information Sharing (RIS) program. The RIS program will enhance the exchange of regulatory information to facilitate generic drug review processes. The objective is to support regulatory alignment and enhance patient access to high-quality, safe and effective generic medicines in both countries. Participation of an application in this program is initiated by HC and subject to the subsequent agreement of the applicant, and FDA. This effort reflects a shared commitment by FDA and Health Canada to advance regulatory efficiency and leverage scientific and regulatory expertise to streamline generic drug review and approval. It can also contribute to more efficient regulatory decision-making and reduce duplication of efforts, which supports more timely access to cost-effective treatments. Learn more: Global Generic Drug Affairs (FDA) Health products international activities (Health Canada) The Generic Drug Cluster Third Anniversary Reflection The Generic Drug Cluster has become an essential forum for international regulatory collaboration, bringing together agencies from around the world to share knowledge, address common challenges, and align on best practices in the oversight of generic drugs. Click here to view the manuscript which outlines the contributions, challenges, and outcomes of the Cluster's activities since its inception in 2021, highlighting the tangible benefits for participating agencies. Strategic Partners 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 Expanding Generic Drug Access Through International Engagements 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).