Opportunity Information: Apply for RFA FD 24 026
This FDA cooperative agreement (RFA-FD-24-026) supports a single, targeted effort to strengthen how national regulatory authority (NRA) inspectorates around the world oversee the manufacturing quality of human and veterinary pharmaceutical products. The focus is on improving good manufacturing practice (GMP) inspection approaches in a way that is data-driven, science-based, and aligned with FDA priorities for integrating inspection activities with modern risk assessment methods, including data modeling that can inform risk-based inspection planning, prioritization, and workplans. Clinical trials are not allowed under this opportunity, since the work is centered on regulatory oversight capacity and inspectional systems rather than clinical research.
The core purpose is to leverage an institution that already has deep, globally recognized expertise in GMP inspectorate quality standards and training, and use that platform to build broader international alignment. The funded work is expected to catalyze efforts to build global consensus on what "optimal" GMP inspections look like, what competencies inspectors and investigators should have, and how inspection programs should plan and prioritize inspections based on well-informed risk assessments. This matters because pharmaceutical manufacturing and supply chains are increasingly complex, innovative, and internationally distributed, which raises the stakes for consistent inspection quality and comparable decision-making across jurisdictions.
A major theme of the award is systems-level harmonization. Rather than producing isolated training materials or one-off workshops, the project is intended to help drive sustainable alignment across multiple NRA inspectorates by promoting common standards, shared practices, and interoperable approaches to inspection planning and execution. In practical terms, the opportunity points toward coordinated inspector training and regulatory expert development, strengthened networking among inspectorates, and approaches that increase mutual confidence in GMP inspection outcomes across countries. The end goal is stronger, more consistent oversight of pharmaceutical supply chains globally, supported by shared expectations for inspector competency and a common understanding of risk-based inspection strategies.
Eligibility is extremely limited. Only the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is eligible to apply. The solicitation also spells out the type of capabilities the applicant must demonstrate: strong institutional linkages with inspectorates worldwide; broad knowledge of GMP procedures and regulatory systems across regions for both human and veterinary medicinal products; leadership in the international development and maintenance of harmonized GMP standards and quality systems; a proven track record working across a diverse range of NRA inspectorates to harmonize and better align inspection procedures through common standards and capacity-building; and demonstrated experience designing competency- and capacity-building programs that strengthen inspector skills and support harmonized inspection procedures.
From an administrative standpoint, the award mechanism is a cooperative agreement (U01), which typically means FDA expects substantial involvement during the project period compared with a standard grant. The opportunity is listed under CFDA 93.103, with an activity category covering areas such as consumer protection and related regulatory public health functions. The agency anticipates making one award, with an award ceiling of $150,000. The opportunity was created on December 21, 2023, and the original application due date was February 27, 2024.
Foreign participation is explicitly permitted in the sense that non-U.S. entities may apply when eligible, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in HHS grants policy) are allowed. In this case, because PIC/S is the only eligible applicant and it is an international cooperation scheme, the design of the program inherently supports global engagement and cross-border collaboration among regulatory authorities.Apply for RFA FD 24 026
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on 2023-12-21.
- Applicants must submit their applications by 2024-02-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others.
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FAQs: FDA Cooperative Agreement RFA-FD-24-026 (GMP Inspectorate Harmonization)
1) What is this funding opportunity (RFA-FD-24-026) about?
This FDA cooperative agreement supports one targeted project to strengthen how national regulatory authority (NRA) inspectorates worldwide oversee manufacturing quality for human and veterinary pharmaceutical products. The emphasis is on improving good manufacturing practice (GMP) inspection approaches so they are data-driven, science-based, and aligned with FDA priorities for integrating inspections with modern risk assessment methods.
2) What is the main purpose of the award?
The project is intended to leverage an institution with globally recognized expertise in GMP inspectorate quality standards and training to drive broader international alignment. The work is expected to help build global consensus on what optimal GMP inspections look like, define inspector and investigator competencies, and advance risk-based inspection planning informed by well-founded risk assessments (including the use of data modeling).
3) Why is FDA supporting this effort now?
The opportunity is framed around the growing complexity and international distribution of pharmaceutical manufacturing and supply chains. As products and supply networks become more complex and globally connected, consistent inspection quality and comparable regulatory decision-making across jurisdictions becomes increasingly important for supply chain oversight.
4) What kinds of improvements does FDA want to see in GMP inspections?
The solicitation highlights improvements that are:
- Data-driven and science-based
- Aligned with FDA priorities
- Integrated with modern risk assessment methods
- Supported by data modeling that informs risk-based inspection planning, prioritization, and workplans
5) Is the focus on human pharmaceuticals, veterinary pharmaceuticals, or both?
Both. The opportunity references GMP procedures and regulatory systems across regions for human and veterinary medicinal products, and it aims to strengthen oversight of manufacturing quality for both categories.
6) Are clinical trials allowed under this opportunity?
No. Clinical trials are not allowed because the work is centered on regulatory oversight capacity and inspectional systems rather than clinical research.
7) What does "systems-level harmonization" mean in this opportunity?
The award is intended to support sustainable alignment across multiple NRA inspectorates, rather than isolated deliverables like one-off workshops or standalone training materials. The emphasis is on promoting common standards, shared practices, and interoperable approaches to inspection planning and execution that can increase mutual confidence in GMP inspection outcomes across countries.
8) What types of activities are suggested by the opportunity description?
Based on the information provided, the opportunity points toward activities such as coordinated inspector training and regulatory expert development, strengthened networking among inspectorates, and approaches that support shared expectations for inspector competency and a common understanding of risk-based inspection strategies.
9) What is the expected outcome or end goal?
The end goal is stronger, more consistent oversight of global pharmaceutical supply chains, supported by shared expectations for inspector competency and a common understanding of risk-based inspection strategies, resulting in more comparable inspection quality and decision-making across jurisdictions.
10) Who is eligible to apply?
Eligibility is extremely limited. Only the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is eligible to apply.
11) What capabilities must the eligible applicant demonstrate?
The solicitation describes capabilities the applicant must be able to show, including:
- Strong institutional linkages with inspectorates worldwide
- Broad knowledge of GMP procedures and regulatory systems across regions for both human and veterinary medicinal products
- Leadership in the international development and maintenance of harmonized GMP standards and quality systems
- A proven track record working across diverse NRA inspectorates to harmonize and align inspection procedures through common standards and capacity-building
- Experience designing competency- and capacity-building programs to strengthen inspector skills and support harmonized inspection procedures
12) How many awards does FDA expect to make?
FDA anticipates making one award.
13) What is the funding level for this opportunity?
The award ceiling is $150,000.
14) What is the award mechanism?
The mechanism is a cooperative agreement (U01). This typically indicates FDA expects substantial involvement during the project period compared with a standard grant.
15) What does substantial FDA involvement usually imply for a cooperative agreement?
Based on the description provided, the cooperative agreement structure generally means FDA will be more involved during the project period than it would be under a standard grant. (The specific form of involvement is not detailed in the provided text.)
16) What is the CFDA listing associated with this opportunity?
The opportunity is listed under CFDA 93.103, with an activity category covering areas such as consumer protection and related regulatory public health functions.
17) When was this opportunity created and what was the application due date?
The opportunity was created on December 21, 2023, and the original application due date was February 27, 2024.
18) Does the opportunity allow foreign participation?
Yes. Foreign participation is explicitly permitted in the sense that non-U.S. entities may apply when eligible, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in HHS grants policy) are allowed. In this specific case, PIC/S is the only eligible applicant and is an international cooperation scheme, so the program inherently supports global engagement and cross-border collaboration among regulatory authorities.
19) Is this opportunity intended to create isolated training materials or one-off workshops?
No. The project is described as aiming for sustainable, systems-level alignment across multiple inspectorates, rather than producing isolated training materials or single events.
20) What is meant by risk-based inspection planning in this context?
The opportunity emphasizes integrating inspection activities with modern risk assessment methods, including data modeling that can inform risk-based inspection planning, prioritization, and workplans. The intent is to support inspection planning that is guided by well-informed risk assessments rather than solely routine or ad hoc scheduling.
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