The Future of FDA Regulatory Inspections:   

The Office of Regulatory Affairs (ORA) at the U.S. Food and Drug Administration (FDA) is currently buzzing with activity and exciting developments. Here’s a snapshot of what happened in the last 24 months: 

In June 2023, the FDA updated its new model for the Office of Regulatory Affairs (ORA). This office is responsible for overseeing the agency’s field force who conduct inspections, investigations, and import operations in support of FDA’s product centers and programs. This remodel involves consolidating various units into a unified ORA, empowering field agents to meet the escalating demands of the agency’s public health mission. 

FDA Data Dashboards now offer insights into compliance and enforcement, showcasing inspections, recalls, imports, and food safety programs. This transparency and accountability aids in analyzing public FDA data visually. 

Post-COVID-19, remote regulatory inspections have become routine. FDA’s draft guidance (July 2022) outlines methods for conducting these inspections entirely remotely, aiding compliance with FDA requirements. 

The FDA is also actively engaged with the International Coalition of Medicines Regulatory Authorities (ICMRA) to strengthen international collaboration between the various Regulatory agencies. The collaborative hybrid inspection pilot is up and running using a combination of on-site inspection and remote assessment tools. A ‘hybrid’ inspection is somewhat like a joint inspection, but in this pilot, only inspectors from one Regulatory authority will be present on-site, with regulators from other countries remotely connecting at the same time. FDA, as the lead inspectorate, with Pharmaceuticals and Medical Devices Agency (PMDA), Swiss Medic, Medicines, and Healthcare Products Regulatory Agency (MHRA), Ministry of Health (MoH) Israel, European Medicines Agency (EMA) and Health Products Regulatory Authority (HPRA) as observers, execute the first collaborative assessment of a Drug Product Manufacturing site in September 2023. The outcomes from these pilots will be revealed in 2024.  

The United States Congress directed the FDA in FY 21 And FY22 to restart its pilot on “Unannounced Inspections.” The intent of the pilot was to evaluate the differences in the number and type of violations identified during unannounced and announced inspections of foreign drug establishments and any other significant differences between each type of inspection. India and China were the initial countries of interest under the pilot. These pilots have been initiated, but there has been some controversy with this approach and FDA has recently abruptly ended a program to conduct unannounced inspections in India in part due to concerns that the project would hinder efforts to deepen relations with the country. The reasons behind this are yet to unfold and will no doubt continue into 2024, with the US House Republicans saying that they are prepared to issue a subpoena should the FDA fail to produce the requested documents by January 05, 2024.  

The mutual recognition agreement (MRA) between the FDA & European Union (EU) was expanded in May 2023 to include inspections of veterinary pharmaceuticals (Animal drugs). In July 2023, the FDA’s MRA with Swiss Medic takes effect, allowing for the sharing of inspection reports (for human and animal drugs) and avoiding the need for duplicate inspections. There are still some limitations and exclusions to the scope of these agreements, e.g., Advanced Therapy Medicinal Products (ATMP’s), but the baseline is now established.  

Finally, the FDA is prioritizing recruitment and investing heavily in investigator training, developing on-the-job, classroom, and online training programs, and providing dedicated training supervisors, peer support, and strategic on-the-job co-ordination. This strategic initiative aims to augment inspectional activities both domestically and internationally. 

Looking ahead into 2024, the future of FDA inspections appears dynamic, with inspectors resuming routine foreign travel. Continuous monitoring of trends in this sphere is crucial, and if support is needed in preparing for collaborative hybrid inspections, CAI is your consulting partner in maintaining cost-effective compliance and operational readiness.