
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
Agencies extend successful pilot program to further harmonization of QbD topics.
FDA and the European Medicines Agency (EMA) have
The extension follows what FDA and EMA have called a successful program that has created inter-agency agreement on a wide range of QbD topics. The program has resulted in the publication of two question-and-answer documents and has created joint research efforts on QbD-related topics. The agencies have agreed that there are further QbD areas that warrant additional inter-agency harmonization and expect to publish more guidance documents in 2014.
The program is open to applications for initial marketing authorizations, type-II variations, and scientific advice. Participation in the pilot is voluntary, and applicants should contact both FDA and EMA at least three months prior to submitting an application. According to
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