Legislative reform in healthcare rarely moves quickly, but the current revision of EU pharmaceutical law represents a major turning point. The European Commission (EC) first proposed the overhaul in April 2023. As of mid-2025 the reform, known as the “Pharma Package”, is now in active interinstitutional negotiation, and the likely changes have significant implications for paediatric drug development, regulatory incentives, and market access.
Where we stand
What these regulatory changes mean for paediatric medicines
The revised EU pharmaceutical legislation introduces several changes that directly affect how paediatric medicines are developed and brought to market. The new approach to regulatory data protection and market exclusivity offers a total of 8 years of data protection and 1 year of market protection, with the possibility of an additional extension when certain criteria are met, such as addressing unmet medical needs or submitting strong comparative evidence from multiple EU Member States. Although this structure remains an important incentive for innovation, the overall protection period will be slightly shorter than previous regimes, meaning that companies will need to plan their development and market strategy more carefully when targeting paediatric use.
The essential requirement for Paediatric Investigation Plans (PIPs) continues, but with greater flexibility built into the process. Notably, an “initial PIP” option has been introduced to support earlier engagement while still allowing refinements to be made as research progresses. This approach may reduce administrative burden during early stages of development and make it more feasible for companies to consider age-appropriate innovations such as taste masked liquids, 3D printed tablets or child friendly solid dispersions.
In parallel, the legislation aims to improve access to medicines for children across the EU. Companies will be expected to ensure that paediatric medicines are supplied in every Member State where the adult version is already available. This requirement has the potential to greatly increase equity in access, but it also brings practical challenges, especially for specialised or lower volume paediatric formulations that may require more resilient and coordinated manufacturing and distribution models.
The incentive system will remain in place for paediatric development, including for orphan medicines where exclusivity provisions continue to offer valuable support. However, companies will still need to consider carefully whether the size of the paediatric population and the development complexity justify the investment required.
Alongside these specific measures, the wider package includes efforts to streamline regulation, increase transparency and improve supply chain stability to prevent shortages — a major issue for paediatric markets that rely on reliable access to age appropriate formulations.
Final thoughts – a cautious but hopeful outlook
The 2025 developments of the EU Pharma Package represent a significant opportunity, potentially making paediatric medicines more accessible, better formulated, and more widely available. At the same time, the approach balances incentives with reasonable regulatory and supply obligations, aiming for sustainable delivery rather than short-term gains.
For organisations like Gustoceutics with scientific grounding in formulation design, taste masking, paediatric acceptability, and regulatory awareness this environment encourages innovation but also demands careful strategy. The next 12–24 months (final trilogue, adoption, transitional period) will be critical.
If the legislation finalises in 2026 and given a transitional phase (as currently proposed 36 months) the earliest practical implementation of the new rules could come by 2028–2029. This provides a window for planning, design, and potentially launching novel paediatric dosage forms under the updated regulatory regime.
