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FDA, EMA to share information on generic drug application inspections
The U.S. Food and Drug Administration and the European Medicines Agency have launched a joint initiative to share information on inspections of bioequivalence studies submitted for generic drug approvals, according to a press release.
The collaboration will provide a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies, the release said. Key objectives of the initiative are to streamline information regarding inspections of bioequivalence studies for generic drug applications; share information about negative inspection outcomes; conduct joint inspections at worldwide facilities; and provide training opportunities to improve bioequivalence inspections.
The European Medicines Agency and France, Germany, Italy, the Netherlands and the United Kingdom are taking part in the initiative. The agreement includes an 18-month pilot phase.