Reflection Paper on the Pharmaceutical Development of Medicines for Use in the Older Population

On 22 October 2020 the EMA issued this reflection paper for medicine developers.

The reflections in this paper apply to any new application for a marketing authorization (MA) or variation to an existing MA, and for all application types including full and abridged MAs (i.e. new medicinal products, generics, well established use). Where appropriate, the reflections may be considered during the clinical trial phases and in the post-authorization phase as part of the product lifecycle management. To support the progression of scientific and regulatory knowledge in the development of medicines for older people / patient-centric medicines, users of this paper are encouraged to actively send feedback to EMA on the basis of their experiences applying the principles of this reflection paper.

Read the pdf 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /