This reflection paper has been written to provide current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes where these are 0 used, or are proposed for use, in drug development and Marketing Authorisation Applications. It was also prepared to invite comments in relation to the opportunities and limitations related to inferential statistical methodology applied on quality attributes' data in the exploration of similarity of two drug products. Whilst in some parts the paper describes Frequentists statistical methods, the field is also open to explore alternative approaches, e.g. following Bayesian methodology.

The current document does not contain explicit guidance on which statistical approaches are mostsuitable. It rather tries to establish a framework and a common language to facilitate futurediscussions among stakeholders.

The content of this reflection paper and its implications shall be further discussed at a European Medicines Agency's public work shop at the end of the 12-month public consultation phase. A longer than usual consultation period will allow companies to come forward to EMA via interaction with the Scientific Advice Working Party with proposals that may include the principles and methods discussed in this document or alternative approaches that are not discussed in this document.

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