ICMRA Suggests Regulators Keep Using Remote Inspections Postpandemic

A global coalition of regulators has recommended permanent use of the remote inspections of drug manufacturing plants that regulatory bodies began to use during the COVID-19 pandemic.

In a new paper, the International Coalition of Medicines Regulatory Authorities (ICMRA) said remote inspections yielded some productive insights, such as the use of digital technology to gather electronic clinical trial data and additional intelligence about manufacturing sites, adding that those approaches should now stay in use as adjuncts to in-person visits by investigators.

“Experience during the pandemic from the ICMRA working group has found the application and availability of technology to enable virtual facility tours to be a key area for consideration to determine the suitability of the remote approach,” wrote the group in the 15-page paper released this week.

The ICMRA set up the working group to review the adaptation of both good clinical practice (GCP) and good manufacturing practice (GMP) inspections during the COVID-19 pandemic to remote approaches.