The FDA and EMA are moving from "confidence-building to  reliance upon" each other in a step-up in cooperation on GMP inspections;  the latest move following successful completion of 

 this summer. The initiative will begin in January 2012,  according to a jointly issued 

 on Dec. 9, 2011, and will enable the two authorities to rely on  each other's inspections outcomes instead of conducting inspections in  duplicate. The objectives are listed below:

To enable better use of inspection resources

To reduce inspection burden of medicines manufacturers

To liberate inspection capacity for other regions.

, released Dec. 7, 2012, the potential for increasing resource  efficiency by moving towards reliance on each other's inspection outcomes was  recognized by both authorities. The statement also notes that the shift of the  manufacturing base away from Europe and the US may justify a change. "Both  sides see this progression as an important next step, and FDA believes that  using EMA as a central contact point in relation to GMP inspections for both  centrally and nationally authorized products is critical," said the  statement.

The initiative will only apply to inspections within the European Economic  Area and US, and will focus on sites with histories of GMP compliance that are  well known to both authorities. Several other points will be taken into  account:

Variations or significant changes since most recent  inspection

The urgent need to expedite regulatory decision-making  (e.g., a product shortage)

EU Member States are being encouraged to use similar approaches for US  inspections that are not directly coordinated by the EMA, which, in some cases,  will require bilateral confidentiality arrangements with FDA.

 For a period of three years, both authorities will track deferred or waived  inspections at which point the approach will be reviewed for the potential of  extension. In the interim, the joint inspection pilot project for dosage forms  will continue with the objective of maintaining confidence and building mutual  understanding of inspection approaches.

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The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer. The initiative will begin in January 2012, according to a jointly issued press release on Dec. 9, 2011, and will enable the two authorities to rely on each other's inspections outcomes instead of conducting inspections in duplicate