The European Medicines Agency and the US Food and Drug Administration are to begin a three-year pilot allowing parallel assessment of relevant quality data for newly-filed medicines.
This 'Quality by Design' (QbD) approach involves "an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality", the EMA said and the agency, along with its counterpart across the pond, will exchange their views "using real applications" submitted to both regulators at the same time.
As part of the programme, which begins on April 1, both agencies will assess the parts of the applications relevant to QbD, such as development, design space and real-time release testing. The evaluation will be performed separately by each agency, "with regular communication and consultation throughout the review, with the aim of having a common list of questions to the applicants and a harmonised evaluation of their responses".
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said that as the number of applications that follow this approach "steadily increases, collaborative assessments will enhance understanding of QbD concepts". She added that the tools used by FDA and EMA reviewers "will increase information sharing and reduce redundancy” and to fully implement QbD, "we need to further harmonise the implementation of the guidelines, work collaboratively, and provide scientific, risk-based regulatory decisions in a timely manner.”
Murray Lumpkin, deputy commissioner of FDA's Office of International Programmes, claimed that the plan 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".