State of play, main conclusions, outlook

The revision of the general pharmaceutical legal framework aims to ensure access to quality, safe, efficacious and affordable medicines in the EU. It aims to foster innovation including in areas of unmet medical need (e.g. antimicrobials) and to enhance security of supply while adapting to new scientific and technological developments and reducing regulatory burden where possible. Drawing lessons from the COVID-19 pandemic, it will support a future-proof and crisis-resistant pharmaceuticals system. The initiative will simplify legislation and create an efficient regulatory environment, among others through reduction of administrative burden and digitalisation in processes and procedures, with an expected positive impact on regulators and companies.

The impact on administrative burden was assessed as part of the policy options considered in the impact assessment. Specifically, the reduction of administrative burden through simplification of legislation and the possibility to use digital technology in medicines regulation and information to patients and healthcare professionals will be a part of any option considered.

The revision of the pharmaceutical legislation will be adopted as a package of two legislative proposals (for a new Directive and a new Regulation), which contain revisions of the general pharmaceutical legislation and also incorporate and revise the Paediatric Regulation and the Orphan Regulation.