A Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development has been released by the European Medicines Agency (EMA) and adopted by the Committee for Medicinal Products for Human Use (CHMP) in July 2021.
This reflection paper targets both experts from industry and regulatory assessors and identifies specific areas where the quantitative comparative evaluation of drug quality characteristics plays an important role from the regulatory perspective.
This might involve decision-making processes potentially leading to marketing authorisation as well as post-authorisation decisions during drug lifecycle. The document focusses on methodological aspects in relation to statistical data comparison approaches for pre- and post-manufacturing changes, biosimilar development, and generics’ development. The reflection paper raises open issues from a statistical perspective, and addresses questions related to comparison objectives, sampling strategies, sources of variability and options (or limitations) for statistical inference.