Strengthening Global Competency and Capacity for Pharmaceutical Inspections | RFA FD 23 022

Opportunity Information: Apply for RFA FD 23 022

The Food and Drug Administration (FDA) grant opportunity titled "Strengthening Global Competency and Capacity for Pharmaceutical Inspections" (Funding Opportunity Number RFA-FD-23-022) is a discretionary cooperative agreement designed to strengthen how pharmaceutical manufacturing inspections are planned, prioritized, and carried out worldwide. The central aim is to reinforce modern, science-based, and data-driven regulatory oversight by improving the consistency and quality of Good Manufacturing Practice (GMP) inspections conducted by National Regulatory Authorities (NRAs). In practical terms, the opportunity focuses on advancing a shared global approach to what a high-quality GMP inspection should look like, what skills and knowledge inspectors need, and how inspection programs can better use risk assessment methods, including data modeling, to decide where to focus limited inspection resources.

A key theme is alignment with FDA priorities, especially the integration of GMP inspection activities with structured risk assessment and risk-based inspection planning. The FDA is looking to support an institution whose best practices already reflect this approach, meaning inspections are not treated as isolated compliance events, but as part of a broader system that evaluates risk across increasingly complex pharmaceutical supply chains. The manufacturing landscape continues to evolve due to new technologies, more globalized production networks, and innovation in pharmaceutical development, and the award is intended to help inspectorates keep pace through shared standards, harmonized procedures, and updated competencies.

The cooperative agreement is intended to catalyze work that builds global consensus in several areas: clear criteria for an "optimal" GMP inspection, a defined set of core competencies for inspectors and investigators, and improved methods for planning and conducting inspections based on well-informed risk assessments. Rather than focusing only on training in the abstract, the opportunity emphasizes a systems approach, where inspector training, inspection procedures, risk prioritization tools, and ongoing collaboration all reinforce one another. The end goal is sustainable alignment across multiple NRA inspectorates so that regulators can rely more confidently on each other’s approaches, strengthen oversight of international manufacturing, and protect public health by improving inspection quality and consistency.

Eligibility is extremely limited. Only one organization is eligible to apply: the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The funding notice lays out why PIC/S is the intended recipient by specifying required capabilities that align with PIC/S’s role in the global GMP inspection ecosystem. The applicant must have strong institutional linkages with inspectorates worldwide, deep knowledge of GMP procedures and systems across countries (for human and veterinary medicinal products), and leadership in developing and maintaining harmonized GMP standards and quality systems. The applicant must also demonstrate a proven record of working across a wide range of NRA inspectorates to harmonize and align inspection procedures through common standards and approaches, provide capacity-building opportunities for inspectors, and facilitate cooperation and networking among inspectional authorities and related organizations. Finally, the applicant must show experience in developing competency-based training programs and capacity-building activities that strengthen inspector skills and support harmonized inspection procedures.

From the funding details provided, the awarding agency is the FDA under CFDA number 93.103, and the award instrument is a cooperative agreement, which typically implies substantial involvement by the FDA in coordination, technical input, or collaborative planning during the project period. The opportunity was created on April 14, 2023, with an original closing date of June 20, 2023. The award ceiling listed is $450,000, and the activity category is described as science and technology and other research and development, reflecting the emphasis on structured, evidence-based approaches, including risk modeling and systematic inspection planning, rather than ad hoc or purely procedural improvements.

Overall, this opportunity is about strengthening global regulatory confidence and effectiveness by standardizing what inspectors are trained to do, how inspections are conducted, and how inspection resources are directed based on risk. By supporting PIC/S and its network, the FDA is aiming for durable international alignment that improves oversight of pharmaceutical manufacturing and supply chains in a way that is consistent, modern, and responsive to scientific and manufacturing innovation.

• The Food and Drug Administration in the science and technology and other research and development sector is offering a public funding opportunity titled "Strengthening Global Competency and Capacity for Pharmaceutical Inspections" 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 2023-04-14.
• Applicants must submit their applications by 2023-06-20. (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 $450,000.00 in funding.
• Eligible applicants include: Others.

Apply for RFA FD 23 022

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