On August 11, 2020 the report on the evaluation of the legislation on medicines for rare diseases and children (Orphan and Paediatric Regulation) was published and is now available on the EMA website >>>

The evaluation found that both Regulations fostered the development and availability of medicines for patients with rare diseases and for children, but they have not adequately managed to support development in all areas of rare and paediatric diseases where the need for medicines is greatest.

The follow-up of the evaluation will be a key pillar of the #EUPharmaStrategy. Based on the outcome of the evaluation, the Commission will examine the impacts of possible future policy options to update the legal framework.