The European Medicines Agency (EMA) has published a new template for requesting compliance checks on agreed paediatric investigation plans (PIPs). The document, released on 4 May 2026, provides a standardised form for pharmaceutical companies to submit when seeking verification that their PIPs meet regulatory requirements. This move aims to streamline the compliance process and reduce administrative burden for both industry and regulators.
The template, titled 'Request for compliance check on an agreed paediatric investigation plan (PIP)', is a non-mandatory guidance document. It outlines the information required for EMA to assess whether a PIP is being implemented as agreed, including details on study status, deferrals, and waivers. By standardising submissions, EMA expects to improve consistency and efficiency in compliance checks, which are critical for ensuring timely paediatric drug development.
Policy orientations and trade-offs The template reflects EMA's ongoing efforts to balance regulatory oversight with industry flexibility. On one hand, standardisation helps EMA process requests faster and reduces the risk of incomplete submissions. On the other hand, some companies may find the template too prescriptive for complex or innovative PIPs. The document does not introduce new legal obligations but serves as a best-practice tool.
Impact on stakeholders - Pharmaceutical companies: The template simplifies the submission process, potentially reducing time and costs associated with compliance checks. However, firms with non-standard PIPs may need to adapt their reporting to fit the template. - EMA: Standardised submissions will likely improve internal efficiency and consistency in decision-making, freeing up resources for other regulatory tasks. - Paediatric patients: Faster compliance checks could accelerate the availability of age-appropriate medicines, though the direct impact depends on how quickly companies adopt the template. - National competent authorities: The template may facilitate harmonised compliance assessments across EU member states, supporting consistent implementation of paediatric regulations.
Expected institutional follow-up EMA will monitor the template's uptake and may revise it based on stakeholder feedback. The agency is expected to issue further guidance on electronic submission formats and integration with existing regulatory systems. No formal adoption by the European Commission is required, as the template is a procedural tool within EMA's remit.
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