EMA and FDA team on QbD parallel evaluation pilot scheme
The voluntary scheme will see reviewers at each agency assess chemistry, manufacturing and control (CMC) data separately and communicate their findings to counterparts on the other side of the Atlantic.
Speaking at the launch of the new project Janet Woodcock, director of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research, explained that the aim of the pilot is to streamline the review process.
"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.
"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 was echoed by Murray Lumpkin of the FDA’s office of international programmes, who said: "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,"
This pilot program applies to NDAs and MAAs, as well as some nutritional supplements, and CMC meeting requests that include QbD elements submitted to both agencies at about the same time.
The pilot, which will only cover chemical entities and not biologically-derived products, will end in March 2014.
