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Tag Archives: EU Paediatric Regulation

The EMA publishes a reflection paper on the use of extrapolation in the development of medicinal products for paediatrics

The reflection paper and extrapolation The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is to provide a framework and guidance for the use of extrapolation in the development of medicinal products in paediatric patients.

Commission opens public consultation on the EU Paediatric Regulation

On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use, as last amended (“the Paediatric Regulation” or “the Regulation”) for public consultation. The consultation deadline for the draft report