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FDA, EMA Announce Pilot for Parallel Assessment of Quality by Design Applications
Date:3/16/2011

A assessors/reviewers to share full knowledge about these applications
  • Developing and harmonizing regulatory decisions to the greatest extent possible.

  • "As the number of applications that follow the QbD approach steadily increases, collaborative assessments will enhance understanding of QbD concepts. The tools used by FDA and EU reviewers will increase information sharing and reduce redundancy," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "To fully implement QbD, we need to further harmonize the implementation of the guidelines, work collaboratively, and provide scientific, risk-based regulatory decisions in a timely manner."

    "This is another concrete example of the very collaborative working relationship we have with our European regulatory colleagues and how we can leverage the scientific resources we both have for the benefit of our agencies and our citizens," said Murray M. Lumpkin, M.D., Deputy Commissioner of FDA's Office of International Programs.  

    This pilot program applies to NDAs and MAAs, some supplements, and CMC meeting requests that include QbD elements submitted to both agencies at about the same time. The pilot will only include chemical entities and not biologically-derived products. Review of QbD applications does not change statutory deadlines. The pilot will end on March 31, 2014.

    For more information:

    International Conference on Harmonization - Quality Guidance

    European Medicines Agency

    International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

    Media Inquiries: Morgan Liscinsky, 301-796-03
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    SOURCE U.S. Food and Drug Administration
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