EMA Plans to Revise GMP Non-Compliance Reports to Help Deal With Possible Shortages

The European Medicines Agency is seeking public comments on a new template for GMP non-compliance statements, specifically in cases where a manufacturing site’s failed inspection could lead to shortages of critical medicines.

Currently, in deciding how to manage the risk presented by non-compliance — such as through recalls, prohibitions, suspensions, etc. — and the possibility of a subsequent shortage, the national regulatory authority conducting the inspection might decide to mitigate or accept the risks, the EMA said. However, the site will remain non-compliant until satisfactory corrective actions are taken.

In order to simplify dealing with serious non-compliance, the agency’s GMP/GDP Inspectors Working Group plans to revise procedures by separating the processes of risk assessment and risk control; accelerating publication of non-compliance statements; and providing specific guidance for qualified persons to release batches of critical drugs, the EMA said.