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  1. Generic Drugs

Global Generic Drug Affairs

 

Syringe, vials, globe

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.

For more information contact:

Sarah Ibrahim, PhD.
Associate Director for Global Generic Drug Affairs
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
sarah.ibrahim@fda.hhs.gov

Debbie Cordaro
Global Affairs Project Manager
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Debbie.cordaro@fda.hhs.gov

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. View a video of the OGD Associate Director of Global Generic Drug Affairs as she provides an overview of the Generic Drug landscape and OGD’s international harmonization efforts.

First Generic Drug Forum Among World’s Leading Regulatory Agencies Launched

The FDA’s Global Generic Drug Affairs program has launched the Generic Drug Cluster, the first forum established for the world’s leading regulatory agencies to address generic drug development globally. The Generic Drug Cluster aims to increase scientific alignment among leading generic drug regulatory agencies by fulfilling the following objectives:

  • 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.
  • 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.
  • 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 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).

International Pharmaceutical Regulators Programme (IPRP)

The International Pharmaceutical Regulators Programme (IPRP) is an established global forum utilized by over 30 regulatory members and observers to exchange information on issues of mutual interest, enable regulatory cooperation and promote regulatory convergence for pharmaceutical medicinal products for human use. The Office of Generic Drugs currently participates on the IPRP Bioequivalence Working Group for Generics (IPRP BE WGG). The working group surveys and collates information in order to identify opportunities for regulatory convergence and harmonization. In addition to developing assessment tools for evaluation of regulatory submissions across jurisdictions. Some of the priority work areas for the BEWGG are bioequivalence study design, biowaivers for immediate-release drug products, modified-release drug products, and other dosage forms, along with acceptance of foreign comparator products, alternate comparator products and data integrity. For additional information, refer to http://www.iprp.global/home.

Additional Resources:

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).

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