n 26 April, the Commission proposed the largest reform to EU’s pharmaceutical legislation in more than 20 years. The revision includes proposals for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases.

The Commission’s announcement includes the reform’s main objectives:

• Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines
• Enhance the security of supply and ensure medicines are available to patients, regardless of where they live in the EU
• Continue to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe
• Make medicines more environmentally sustainable
• Address antimicrobial resistance and the presence of pharmaceuticals in the environment through a One Health approach.

Read Global Forum for future analysis of and updates on this legislative and regulatory reform.