US-EU mutual GMP recognition likely to be delayed

The suspension of the Transatlantic Trade and Investment Partnership (TTIP) by the US looks likely to delay the mutual recognition of GMP inspections between the US and EU.

Last autumn it was reported that an agreement on GMP mutual recognition was anticipated in January 2017. Although such an agreement hasn’t emerged, the most recent update from the negotiations indicated that things were still on track. The progress report date 17th January stated “In the pharmaceutical sector, for example, we made substantial progress towards updating our mutual recognition agreement on good manufacturing practices (GMP) inspections, which would reduce duplicative requirements on manufacturers of pharmaceutical products and allow regulators to allocate resources more efficiently and where they are most needed, benefitting public health.”

There are GMP mutual recognition agreements in place between the EU and Australia, Canada, Israel, Japan, New Zealand and Israel and Switzerland but not with the US. For the moment at least, it seems everything is in limbo.