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Mutual Recognition Agreement for GMP Inspections between US and EU is finalized: Applicable to both the regions.

A big step towards saving time and money came into being when following a three-year-process, the United States (represented by the US FDA) and the European Union (represented by the European Commission) finally announced their agreement to mutually recognize each other's GMP inspections of pharmaceutical facilities.

A joint statement released by US FDA stated that the agreement will allow both the regulatory agencies i.e. FDA and European Union to use the information generated from drug inspections conducted within each other’s borders. Eventually it will avoid duplication of efforts, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.

Currently, EU has such mutual recognition GMP agreements in place with Switzerland, Australia, New Zealand, Japan, Canada (with some limitations) and Israel (with some exclusions).

References
  1. EU:Trade
  2. FDA:Press Announcement

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