EMA and FDA announce pilot for parallel assessment of QbD
Collaboration will enhance understanding of QbD concepts
The European Medicines Agency and the US Food and Drug Administration are launching a voluntary three-year pilot programme that will allow parallel assessment of relevant quality data for new drug applications.
The components, known as Quality by Design (QbD), will be evaluated separately and assess the quality/chemistry, manufacturing and control (CMC) section of new drug applications (NDAs) submitted to the FDA and marketing authorisation applications (MAAs) submitted to the EMA.
QbD in pharmaceuticals involves a systematic and science-based approach to designing and developing pharmaceutical formulations and manufacturing processes better to ensure product quality.
Several guidelines have been developed by the International Conference on Harmonisation (ICH) to harmonise and facilitate the implementation of QbD. This new pilot arose from concern that certain ICH guidelines were being interpreted differently in Europe and the US, the FDA said.
Under this programme, both agencies will assess the parts of the applications relevant to QbD, such as development, design space and real-time release testing.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said: ‘As the number of applications that follow the QbD 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’.
‘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,’ she said.
Murray Lumpkin, deputy commissioner of the FDA's Office of International Programmes, said 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’.
The pilot, which starts on 1 April, will only include chemical entities and not biologically derived products. It ends on 31 March 2014.
