FDA, EMA program would allow joint inspections of generic drug manufacturing facilities

U.S., E.U. agencies to share bioequivalence data

SILVER SPRING, Md. — The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

The FDA and the EMA, which regulates drugs in the European Union, said the effort would provide a way to conduct joint inspections of drug makers' factories and other facilities for generic drug approval applications submitted to both agencies. Under U.S. and E.U. regulations, studies submitted for generic drug applications must demonstrate scientifically that they are "bioequivalent," meaning they're as safe and effective as the branded drugs they're based upon. The FDA and E.U. regulatory authorities inspect drug makers' manufacturing facilities to ensure the data they submit are reliable.

"Our continued collaboration with the EMA and the E.U. enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalization in drug development," FDA Center for Drug Evaluation and REsearch director Janet Woodcock said. "By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs."

The FDA, EMA and individual E.U. member states France, Germany, Italy, the Netherlands and the United Kingdom will all take part in the initiative, the FDA said.


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