EMEA publishes plan for coordinating GMP inspections worldwide

As part of its collaboration with international drug regulators on goods manufacturing practice inspections, the European Medicines Agency (EMEA) has coordinated a group of participating regulators - European Union member states, the US Food and Drug Administration and the Australian Therapeutic Goods Administration - and has published a proposal for coordinating inspection plans between them to avoid duplicating work.

The outline of the pilot project was published on the EMEA web site on July 22. The basic idea is that each regulator identifies a contact point specifically for planning inspections and then set out their preliminary inspection plans for the next six to 12 months and provide this information to all other regulators involved in the pilot. A template for this information may be agreed.

After reviewing each other's plans, the agencies identify: if they have previously inspected the site; if they plan to inspect the site within the same period; if they have an interest in the site for some other reason; and if they have no interest. They communicate this information to the other regulators involved by way of a form.