EMA and FDA to co-operate on plant inspections
Initiative will start in January 2012
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are to rely on each other’s inspection results in the future rather than staging parallel probes of the same medicines.
An initiative starting in January will cover inspections of manufacturing plants for human and veterinary medicines in the USA or the European Economic Area (the European Union plus Iceland, Norway and Liechtenstein).
This collaborative work will focus on plants already known to the two authorities which, said EMA, ‘have a history of compliance with good manufacturing practice following previous inspections’.
EMA said the agreement would promote better use of the two authorities' inspection resources; reduce the burden of inspections for medicine manufacturers; and enable the FDA and EMA to shift inspections to new targets.
The move follows August’s completion of two pilot projects involving the sharing of information on inspections. The initiative will be reviewed after three years.