Scientific guideline: Concept paper on extrapolation of efficacy and safety in medicine development, draft: consultation open
This concept paper is intended to discuss the need and possibility to develop a framework for
extrapolation approaches that are considered scientifically valid and reliable to support medicine
authorisation. The framework shall set out a structured approach to be followed for each extrapolation
exercise to improve interactions with stakeholders and to standardise the decision making across European Medicines Agency committees. Since the application of extrapolation varies by population, therapeutic area and
medicinal product, an inventory of approaches and case examples will be collected.
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