The state of play and the organisation of the evaluation of the US and the EU GMP inspectorates were discussed:
Beyond the MRA of GMP inspections, the harmonization in other areas was discussed. One of them is the EU proposal for an annex on medical devices. The EU and the US proposals for an annex on medical devices have been put side by side in order to identify commonalities. For some provisions, notably the unique device identification, the regulated product submission and the single audit first attempts of common language have been discussed. In addition, the EU provided an update on the state of play of its new medical device regulations.