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
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.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Generic Drug Discussion Group (GDG)
The ICH GDG was established in 2019 following endorsement of the ICH Reflection Paper “Further Opportunities for Harmonization of Standards for Generic Drugs.” The ICH GDG serves as a technical discussion group for issues relevant to harmonization of scientific and technical standards for generic drugs. The GDG recommends areas for harmonization under ICH and assesses the feasibility and impact of harmonization of various topic areas within existing regional regulatory frameworks.
The OGD-led GDG was granted their request to extend their term for one-year and in June 2020, the group began its second year focus of identifying potential topics for harmonization that are feasible and impactful, including focusing on more complex generic drug products. The work of the GDG paved the path for the development of the ICH M13 expert working group, which formed in July 2020 and represents the first ever ICH guideline (M13) focusing on generic drugs.
In addition to engagement with ICH, OGD continues leading efforts in numerous working groups within the International Pharmaceutical Regulators Programme (IPRP) and Global Bioequivalence Harmonization Initiative (GBHI).
- FDA: Advancing Toward the Goal of Global Approval for Generic Drugs: FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs
- ICH Reflection Papers: Further Opportunities for Harmonization of Standards for Generic Drugs
Information and Resources for Foreign Regulators
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).
- Abbreviated New Drug Application (ANDA)
- Annual Reports
- CDER Conversations: The Generic Drug Approval Process
- Developing and Manufacturing Drugs Including Biologics
- Generic Drug Development
- Generic Drug Science and Research
- Office of Generic Drugs: Offices and Divisions
- Office of Pharmaceutical Quality
- Pharmaceutical Quality Resources
- Pre-ANDA Program
- Product-specific Guidances for Generic Drug Development
- What Is the Approval Process for Generic Drugs?