The regulatory authorities in the US and EU have taken another step towards harmonisation by agreeing to pool their resources when inspecting facilities involved in generic drug applications.
The FDA and European Medicines Agency have agreed to expand their joint Good Clinical practice (GCP) inspection activities to include facilities involved with bioequivalence studies for generic drug applications. An 18-month pilot – which will also involve regulators from EU member states – is due to start in January and last for 18 months. Along with joint inspections of clinical facilities and analytical facilities, information will be shared on inspections and the partners will work together to train inspectors, according to the agencies.
As part of the initiative, the FDA and EMA also hope to streamline the identification of problems that raise questions about the reliability of data submitted in bioequivalence studies used to verify that generic medicines are substitutable for their branded counterparts.
The EU member states participating in the GCP bioequivalence programme are France, Germany, Italy, the Netherlands and the UK.
The FDA and EMA are already carrying out an estimated 80 formal interactions on marketing applications per month, according to information presented recently at the European Health Forum, and the addition of generic drug applications will expand the bilateral arrangement. The programme builds upon the successful FDA/EMA GCP inspection initiative launched in 2009, which introduced collaborative inspections and information-sharing, as well as a programme to inspect Good Manufacturing Practice (GMP) facilities making active pharmaceutical ingredients which was introduced in the same year.
The GMP initiative was extended in 2011 to include finished dosage form manufacturing plants, and in recent comments by the EMA the level of collaboration between the two agencies has moved beyond ‘confidence building’ pilots to a position where each agency relies on the findings of its counterpart. It allows some inspections on each other’s territories to be deferred or waived.
Meanwhile, the GCP inspection scheme has recently been expanded to include non-EU and non-US sites, while the FDA and EMA are also sharing information and expertise on biosimilars, quality by design (QbD) and active substance master files. Both programmes will help the regulators better “enhance our ability to leverage inspection resources and helps us meet the challenges of increased globalisation in drug development”, commented Janet Woodcock, director of the FDA’s Center for Drugs Evaluation and Research.
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