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.
Intro to Global Generic Drug Affairs
Listen to find out why FDA proactively surveys the global landscape and identifies emerging international areas of common interest including safety issues. Through our Global Generic Drug Affairs program, we engage with our regulatory counterparts and stakeholders to foster FDA’s mission of assuring the safety, efficacy, and quality of FDA-regulated drug products.
Overview of the Generic Drug Landscape and International Harmonization Efforts
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
- General Principles Pilot Program: EMA-FDA Parallel Scientific Advice for Complex Generic Drug/Hybrid Products
- EMA: How Scientific Advice Works
Comparing FDA and EMA Decisions for Market Authorization of Generic Drug Applications covering 2017–2020 White Paper
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Generic Drug Discussion Group (GDG)
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?