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A problem shared: EMA and US FDA team on generics site inspections

By Gareth MacDonald+

19-Dec-2013

The EMA and US FDA will conduct joint site inspections and share the results of assessments of bioequivalence data for generic drugs under an accord announced last night.

The collaboration – which will begin with an 18-month pilot phase on January 2 - expands on the good clinical practice (GCP)-focused data sharing partnership the two regulatory agencies established in 2009 .

Under the new accord the US Food and Drug Administration (FDA) and the Europe Medicines Agency (EMA) will share data from assessments of bioequivalence studies – including the results of facility inspections - and conduct joint visits to sites worldwide.

Additionally, the regulators say they plan to develop a joint inspector training programme under the collaboration, which is known as “EMA-EU MSs-FDA initiative on inspections for Generic Applications.”

Multi-country collaboration

Unlike the US FDA, the EMA does not have its own inspection staff and instead co-ordinates with regulators in individual member States who inspect sites involved in the development and production of generic drugs that are subject to centralised marketing authorisations.  

This structure informs how the new collaboration will operate according to an EMA spokeswoman, who told in-Pharmatechnologist.com inspectors from France, Germany (BfArM), the UK, Italy and the Netherlands will be involved in the new initiative.

From the FDA side, the Office of Regulatory affairs (ORA) field staff will perform these inspections and they may be accompanied by staff from the Center of Drug Evaluation and Research (CDER), which initiates the inspection request.

She added that: “The number of inspectors involved depends on the number of inspections requested according to the national inspection programmes of the countries involved and the triggers for inspections identified.”

Data exchange

A key focus for the new partnership is the exchange of information between agencies when a problem is detected, which was also a core aim of the 2009 collaboration.

When such issues are identified the regulators plan to share it with their compatriots through teleconferences and email exchanges using the EMA’s secure Eudralink file transfer network.

The spokeswoman said that: “One of the main objectives is to communicate effectively and in a timely manner on negative inspection outcomes that reveal system problems of the facilities involved in the conduct of those trials and with potential impact on the acceptability/reliability of the data obtained from other studies conducted in the same facility.

This implies exchange of information on the system failures observed at the sites inspected, corrective actions recommended and the inspection reports if required.”

Cost and workload

Most observers who have reported the new collaboration suggested it provides the regulators with a means of reducing the number of inspections they carry out, citing the US FDA’s large burden of ‘overseas’ inspections as a key motivator for the agency’s involvement.

Data from EudraCT 

But while a reduction in the number of inspections conducted may be one outcome, the idea is more about making better use of resources in a way that ultimately benefits patients according to the EMA.

Taking into account that inspection resources are limited, the intention of this type of initiative is to avoid the duplication of inspections, prioritise the facilities to be inspected, improve inspection coverage and use available inspection resources more efficiently.  

Therefore this does not mean necessarily that there will be fewer inspections but that the inspection coverage will be better” the spokeswoman said, explaining that the idea is to avoid duplicate inspections and allow the EMA and FDA to focus on facilities that have never inspected.

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