EMA: Terms of reference and procedures for participating authorities (manufacturers of medicinal products)

The overall objective is to see whether greater international collaboration can help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication. The purpose of this paper is to outline common principles and terms of reference for agreement between US FDA and EU National Regulatory Authorities (under the coordination of the EMA) for joint inspections, taking into account risk based approaches, building on equivalent GMP standards and mutual confidence between international regulators.