FDA And MHRA Say Remote And Hybrid Inspections To Continue

At the 2022 Drug Information Association Annual Meeting, held in-person in Chicago June 20-23, representatives from the compliance offices of the FDA and MHRA gave a detailed assessment of the pros and cons of remote inspections for Good Clinical Practice (GCP). Driven by the COVID-19 pandemic, regulatory agencies and industry have been forced to grapple with how to conduct effective inspections, while maintaining public health protocols. 

The key takeaway? While challenging, remote inspections – as well as their hybrid cousins (conducted remotely but with some level of on-location presence by regulators) – played an important role in most regulators’ inspection toolkits (see Figure 1), and will continue to be utilized going forward.