The European Medicines Agency (EMA) has introduced a standardised form for paediatric investigation plans (PIPs), aiming to streamline the submission process for pharmaceutical companies developing medicines for children. The new template, published on 16 April 2026, replaces the previous free-text format and is designed to reduce administrative burden and improve consistency in applications submitted to the Agency's Committee for Medicinal Products for Human Use (CHMP).
Document details and purpose
The document, issued by the EMA's Human Medicines Division, is a mandatory template for all new PIP applications. It requires sponsors to provide structured information on the proposed paediatric development programme, including study design, age-appropriate formulations, and timelines. The standardisation is intended to facilitate faster assessment by the CHMP and ensure that all relevant aspects of paediatric drug development are addressed systematically.
Policy orientations and trade-offs
The move reflects a regulatory push to increase the availability of medicines for children, a historically underserved population in drug development. By simplifying the submission process, the EMA aims to encourage more pharmaceutical companies to invest in paediatric research. However, the standardised format may limit flexibility for sponsors developing innovative therapies that do not fit neatly into predefined categories. Critics within the industry have raised concerns that the template could stifle scientific creativity and impose additional upfront costs for adapting to the new format.
Impact on stakeholders
- Pharmaceutical companies: The new form reduces uncertainty and preparation time for PIP applications, potentially lowering development costs. However, companies with complex or novel paediatric programmes may face challenges in aligning their proposals with the standardised structure, requiring additional resources for compliance.
- Children and paediatric patients: Faster and more consistent assessment of PIPs could accelerate access to new medicines tailored for children, addressing unmet medical needs. Yet, if the template discourages innovative trial designs, some rare or complex conditions may remain underserved.
- Healthcare providers: Clearer and more predictable paediatric development plans may improve the availability of evidence-based treatments for children, aiding clinical decision-making.
- National health systems: Standardised PIPs could facilitate earlier inclusion of paediatric medicines in national formularies, potentially reducing long-term healthcare costs. However, if the new process leads to a surge in applications, national regulatory agencies may face increased workload for parallel assessments.
Expected institutional follow-up
The EMA will monitor the implementation of the new form over the next 12 months and may issue revisions based on feedback from sponsors and CHMP assessors. The Agency has also committed to providing training materials and a helpdesk to assist companies in transitioning to the standardised format. This initiative builds on the EMA's broader efforts to enhance regulatory efficiency, as seen in the April 2026 list of new medicines under evaluation, which highlighted the ongoing pipeline of paediatric therapies.