The European Commission has just adopted the proposal of the revision of the European pharmaceutical legislation.

This revision is the first major review of the pharmaceutical legislation since 2004 and includes a proposal for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislative framework, including the one on medicines for children and for rare diseases.

The revision is meant to make medicines more available, accessible and affordable for all patients across Europe by creating a Single Market, while ensuring medicines supplies to patients. It will support innovation and boost the competitiveness and attractiveness of the European pharmaceutical industry, while promoting higher environmental standards. The new pharmaceutical legislation also aims to reduce the administrative burden by speeding up procedures to allow patients to get medicines faster. A focus on antimicrobial resistance is expected as well.

The revision was based on a series of consultations, evaluations and impact assessments. In parallel relevant studies were conducted to support these evaluations and impact assessments.

Fondazione Gianni Benzi Onlus, together with BearingPoint, PPMI Group and Asklepios, produced the “study supporting the Impact Assessment of the revision of the EU legislation on medicines for children and rare diseases” which analysed the possible impacts of policy options to update the legal framework on medicines for children and rare diseases. The two Regulations were evaluated together, considering that most rare diseases may already affect children and many paediatric diseases are also rare.


Keep following us to discover more about the next steps of the revision.

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