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U.S. Department of Health and Human Services

Drugs

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FDA-EMA extends pilot program of the QbD parallel-assessment

The FDA and the European Medicines Agency have agreed on a two-year extension of the joint pilot program disclaimer icon  for the parallel evaluation of quality-by-design applications beginning April 1, 2014.

FDA and EMA began the joint venture in March, 2011, to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the U.S.

QbD is an approach to ensuring consistent drug quality through statistical, analytical and risk-management methodology in drug design, development and manufacturing.

The three-year pilot program has created inter-agency agreement on a wide range of QbD topics, culminating in the publication of two question-and-answer documents for the benefit of industry and agency regulators, while spurring joint research efforts on QbD-related topics.

In spite of these successes, the agencies have agreed that there remain QbD areas that warrant additional inter-agency harmonization, resulting in the decision to extend the pilot. The agencies expect to publish more documents in 2014.