On Wednesday April 26, 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, which revise and replace the existing general pharmaceutical legislation.
The EU Commission’s proposed revisions include proposals to update the EU’s Regulations on Orphan Medicinal Products and Paediatric Medicines, which are very important to Europe’s population of patients who live with a rare disease, including of course the rare forms of pulmonary hypertension.
EURORDIS, the European Rare Disease Organisation, has published a statement commenting on the proposed revision, in which it says it welcomes the changes, which will lead to:
- more rapid regulatory pathways for new products
- more targeted incentives for companies to develop much needed medicines
- placing the EU on a more competitive footing with the US and other regions
Read the full EURORDIS commentary to the proposed EU legislation at this link
The European Patient Forum (EPF), one of the key European public health NGOs, highlights the fact that the revision will contribute to making the EU regulatory framework more patient-centred by:
- promoting patient involvement in the regulatory process
- improving access to safe and efficient medicines
- developing new medicines that better address unmet medical needs
Read the full EPF commentary to the EU proposed revision here