US, EU Look to Mutually Recognize GMP Inspections by January 2017

The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP).

A major sticking point for both FDA and EMA is the question of trade secret information (inspections typically involve specifications of manufacturing equipment and processes for manufacturing drugs that are proprietary information).

The negotiations on the GMP inspections, which took place from 3 October to 7 October in New York, are part of a larger trade deal between the US and EU, where other potential areas for pharmaceutical and medical device regulatory harmonization are under discussion.

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