EMA and FDA move closer on inspections
pharmafile | December 12, 2011 | News story | Manufacturing and Production | EMA, FDA
The EMA and US FDA has taken a step closer to mutual recognition of manufacturing site inspections, launching a three-year pilot last week to share work on facility inspections – including those making finished dosage forms – in each other’s territories.
The initiative is set to get underway in the New Year will enable the two authorities to “rely on each other’s inspection outcomes rather than carrying out separate inspections in duplicate”, said the EMA in a statement.
For the time being it will be used only for facilities located in the US or European Economic Area, and 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.
The move follows the successful completion earlier this year of a two-year pilot inspection programme between the EMA, FDA and Australia’s Therapeutic Goods Administration on active pharmaceutical ingredient (API) manufacturing facilities.
The pilot identified 97 sites that were common to all three regions, resulting in the exchange of nearly 100 inspection reports, helping to avoid duplicate inspections. It also allowed the three agencies to carry out joint inspections on nine facilities.
The latest initiative is designed to enable better use of the FDA and EMA’s inspection resources, reduce the burden of inspections for medicines manufacturers, and allow the authorities’ inspection capacity to be shifted to other, potentially more high-risk regions.
Regulatory agencies are trying to work more closely together on inspections in part to answer criticisms that they are failing to exercise adequate oversight of manufacturing facilities, in the face of a globalisation in the supply chain for pharmaceuticals and their ingredients.
For example, in 2009 the US General Accounting Office published a report indicating that the FDA was able to inspect only a small proportion (11%) of the 3,700-plus overseas facilities supplying APIs and finished drugs to the US market.
“Pharmaceutical manufacturing has increasingly shifted away from Europe and the US,” said the FDA.
In response, the EMA and FDA have developed a joint document to describe a strategy whereby “some GMP inspections of US and EEA manufacturing sites may be deferred or waived based on inspectional findings of the other regulator and if certain other conditions are met.”
The FDA commented that: “Both the public and the public health agencies will benefit by the resource efficiencies gained.”
Phil Taylor
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