Enhancing GMP Inspection Cooperation between EMA and FDA
The U.S. Food and Drug Administration (FDA), together with the European Medicines Agency (EMA), today released a joint document describing further collaboration in our Good Manufacturing Practice inspection programs for human and veterinary pharmaceutical products.
Currently, FDA conducts a significant number of inspections in the European Economic Area (EEA) and vice versa. However, pharmaceutical manufacturing has increasingly shifted away from Europe and the USA. The document describes 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.
Both the public and the public health agencies will benefit by the resource efficiencies gained. We intend as a result of this arrangement to reduce inspections of manufacturing sites in Europe and shift some inspection capacity to other regions.
Already FDA and EMA have shared inspection information and outcomes (as allowed by respective laws and agreements), engaged in various pilot programs and gained confidence in each others’ inspection processes and standards.
This initiative is another step in FDA’s global strategy released in June, “Pathway to Global Product Safety and Quality” aimed in part at collaborating with international regulators to better ensure the safety and quality of drugs globally.