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.

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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.

**NEW** FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

FDA and European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for FDA’s complex generic drug products and of marketing authorization applications (MAAs) for EMA’s hybrid products. This pilot program is an expansion of FDA and EMA’s existing PSA for new drugs and biological products.

The pilot program allows prospective applicants of ANDAs to FDA and MAAs to EMA to submit a request for a meeting with both agencies to discuss specific questions regarding the development of complex generic drug/hybrid products. The goal of the PSA pilot program is to provide a mechanism for FDA and EMA assessors to concurrently exchange their views on scientific issues with applicants during the development phase of complex generic drug/hybrid products, which are generally more challenging to develop with traditional bioequivalence methods. Through the PSA process, applicants would gain an understanding of both agencies’ recommendations.

Successful collaboration between FDA and EMA via the PSA pilot program may provide applicants with a deeper understanding of the basis of regulatory decisions from both agencies, optimize applicants’ global product development programs, and help applicants avoid unnecessary replication of studies or unnecessary diverse testing methodologies to satisfy both agencies, which can shorten the time to approval.

Industry can now request PSA meetings for complex generic drug/hybrid products by sending a single “Request for PSA” letter (justification letter) to both EMA at [email protected] and FDA at [email protected] to initiate the PSA process.

Meeting requests will be received until FDA and EMA determine the number of completed PSA meetings is sufficient to assess the pilot program. During and after conclusion of the pilot, each agency will evaluate the benefits and challenges of the program, including the resources required, and determine next steps. Refer to the General Principles document for FDA and EMA’s recommendations on what to include in this request and the subsequent PSA processes.

Questions about the program may be directed to [email protected].

Related Links

• General Principles Pilot Program: EMA-FDA Parallel Scientific Advice for Complex Generic Drug/Hybrid Products
• EMA: How Scientific Advice Works

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:

• 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
• A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme, published in the Journal of Pharmacy and Pharmaceutical Sciences, 24, 113-126, 2021.

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?