Words by Jade Williams
The European pharmaceutical sector is on the brink of transformative regulatory and operational updates, with the release of position papers from several European pharma associations.
The documents laid out by AESGP, EFPIA and Medicines for Europe outline critical steps towards the adoption of electronic Product Information (ePI) and the modernisation of patient information leaflets (PILs) – with a focus on improved accessibility, sustainability and efficiency.
It is proposed that the transition to ePI will be fully operational within four years of the entry into force of the revised General Pharmaceutical Law. Its adoption will come before the phase-out of paper leaflets, ensuring uninterrupted access to medicinal information for patients.
PILs will also undergo significant enhancements to improve layout and readability, aligning with efforts to boost health literacy and ensure medicines are used correctly. Companies should prepare to make these design improvements to meet evolving patient and regulatory expectations.
Other benefits of the electronic leaflets include real-time updates, personalised content and formats such as large print or multimedia. They will also simplify multi-country packaging production by harmonising labelling and introducing language exemptions, and centralise information on a single portal, reducing administrative burdens while promoting transparency and compliance in the EU.
However, inclusivity remains a priority, and alternatives will be made available for those without internet access to ensure vulnerable populations aren’t left behind.
This transition marks a significant shift in how the industry interacts with patients and regulators, balancing innovation with the imperative need to maintain patient safety and operational integrity.
