US FDA and European Regulators Launch Generic Drug Inspections Initiative

The joint initiative will share information on inspections of bioequivalence studies submitted in support of generic drug approvals, providing a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies. Taking part in the collaborative initiative are the EMA and the European Union (EU) member states France, Germany, Italy, the Netherlands, and the United Kingdom. The initiative will be implemented using confidentiality arrangements already established among the European Commission, the EMA, interested EU member states, and the FDA.

Key objectives of the initiative are to streamline information sharing on inspections of bioequivalence studies conducted and planned for generic drug applications, with inspectional information shared for clinical facilities, analytical facilities, or both; sharing of information about negative inspection outcomes that reveal system problems at a facility; conducting joint inspections at facilities all over the world; and providing training opportunities to improve bioequivalence inspections.

“Our continued collaboration with the EMA and the EU enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalization in drug development,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CEDR). “By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs.”

Pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and they display comparable bioavailability when studied under similar experimental conditions. Bioequivalence is considered proven if the drugs are similar to such a degree that in terms of peak (Cmax and Tmax) and total exposure after administration of the same molar dose (under the same conditions), the effects can be expected to be essentially the same.

Related Links:
US Food and Drug Administration
European Medicines Agency