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Pharmaceuticals / Commercial Operations

EMA Work Group Issues 2017 Agenda for GMPs and Distribution Guidelines

March 10, 2017

The EMA’s inspector working group on good manufacturing and distribution practices set target dates for proposed revisions to guidelines, and said it is considering whether amendments are required in order to assure data integrity in GMPs.

The working group also anticipates further international regulatory alignment under mutual recognition agreements, such as the one published this week on manufacturing inspections between the U.S. and the European Union.

Beyond ICH guidelines, the EU plans to maintain its other mutual recognition agreements with Canada, Japan, Switzerland, Australia, Israel and New Zealand.

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