
FDA and European Medicines Agency Announce Generic-Drug Application Inspections Initiative
FDA and EMA launch initiative to share bioequivalence inspection information.
FDA and the European Medicines Agency (EMA) have announced a
“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, M.D., director of the FDA’s Center for Drug Evaluation and Research, in
Taking part in the initiative are the EMA and the EU member states France, Germany, Italy, the Netherlands, and the United Kingdom. This initiative will be implemented using the confidentiality arrangements established among the European Commission, the EMA, interested EU member states, and FDA. This agreement includes an 18-month pilot phase and follows the
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