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EMA proposes waiving inspection of US plants in some cases

By Nick Taylor , 21-Jun-2011

The EMA has proposed to the FDA that European inspections of US manufacturing plants are waived when certain criteria are met.

Inspectors approached the European Medicines Agency (EMA) with the proposal, leading to a draft plan being written and shared with the US Food and Drug Administration (FDA). The regulators have been working together more closely to make better use of limited resources and the EMA is looking to build on progress made so far.

We're looking to move from confidence in, to reliance on”, said David Cockburn, head of manufacturing and quality compliance at the EMA, at DIA 2011 in Chicago. Waiving the need to inspect US plants that meet certain, as yet undefined, criteria would be a clear move in this direction but an agreement still needs to be reached.

In the meantime the EMA and FDA, as well as other regulators, continue to collaborate. Joint inspections are one, high-profile element of the new culture of collaboration but efforts extend into a number of areas.

For instance, Carmelo Rosa, branch chief, division of manufacturing and product quality at the FDA, gave the example of an import alert being issued based solely on an inspection by the European Directorate for the Quality of Medicines and Healthcare (EDQM).

In this “unprecedented”, first-of-its-kind case the FDA saw the inspection findings, discussed them with the EDQM, and then issued the alert. Rosa hopes to see more of this sort of activity.

The FDA is also including European reports in its 'desktop reviews'. In one case, cited by Rosa, the FDA decided a company under import alert still needed to progress before re-inspection after reading a European report that found the plant was yet to resolve its problems.

Further progress can be made by working more closely with industry groups, said Stephan Karl Roenninger, head of external relations, Europe and Japan, at Roche. Roenninger gave the example of a site that was inspected or audited 21 times in a year to highlight the potential to reduced overlaps through harmonisation.

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