ICMRA Plans Pilot Programs on Hybrid Inspections and Post-Approval Changes

The International Coalition of Medicines Regulatory Authorities (ICMRA) is calling for applications from industry sponsors to take part in two pilot programs that focus on hybrid inspections and collaborative assessments of post-approval changes that involve chemistry, manufacturing and control.

Scheduled to get underway in September 2022, the pilots will focus on developing a common framework for collaborative assessments. One goal is to develop a single list of questions for sponsors or manufacturers, wherever possible, for harmonization across participating regulators.

The FDA and other regulatory authorities are increasingly using hybrid inspections — a mixture of remote monitoring and onsite physical inspections — based on virtual tools developed during the pandemic.

The ICMRA pilot programs are expected to last for one year and reports summarizing the key lessons learnt and recommendations are anticipated by the end of 2023.