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EMA and FDA announce that they will share manufacturing site inspections

Monday the 19th December 2011

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other’s territories.

The initiative, starting in January 2012, will enable the two authorities to rely on each other’s inspection outcomes rather than carrying out separate inspections in duplicate. This is expected to:
• Enable better use of the two authorities’ inspection resources;
• Reduce the burden of inspections for medicines manufacturers;
• Shift the authorities’ inspection capacity to other regions.

The initiative will apply to inspections of manufacturing sites of human or veterinary medicines in the European Economic Area or United States of America. It will focus on sites that are already known to the two authorities and have a history of compliance with good manufacturing practice (GMP) following previous inspections.

This is the latest step in increased collaboration between European authorities and the FDA. In August this year, the authorities announced the successful completion of two pilot projects involving the sharing of information on inspections.
The outcomes of the initiative will be reviewed after three years.

Best regards,

Peter Gough, Partner

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