EN PL

EMA: Concept paper on extrapolation of efficacy and safety in medicine development

05.07.2012
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.