EFPIA welcomes the announcement of the adoption of an updated EU-US Mutual Recognition Agreement (MRA) on Good Manufacturing Practices (GMP) inspections.
Implementation of the MRA will avoid duplication and optimize the use of resources for both regulators and the pharmaceutical industry, resources that are better spent on medical innovation. This is particularly relevant for SMEs where duplicative site inspections impose proportionately greater burdens.
The final agreement is the result of many years of technical cooperation, the sharing of expertise and detailed negotiations between European and American regulatory authorities. As the twin engines of medical research and development over many decades, both the EU and US hold the highest standards for GMP, and we expect implementation of the MRA to reduce unnecessary, duplicative inspections that are being conducted on both sides of the Atlantic.
Under the MRA, these benefits will be realised across all pharmaceutical products, except for vaccines, which will be phased in at a later date. EFPIA advocates the inclusion of vaccines in the MRA as soon as possible, in order to bring the full benefit of such an agreement to bear.