Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches

The European Union's Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory framework. This paper therefore describes bottlenecks identified by industry that occur during the medicinal development process, including those relating to the scientific advice process, pediatric investigation plan (PIP) development, compliance checks, and study submissions, and offers some considerations and insights to address these. Considerations, which are workable within the current legislative framework, focus on an integrated scientific discussion, optimization of PIP procedures and compliance checks, and an alignment of study-reporting requirements.

Automated summary

The European Union's Pediatric Regulation has played a significant role in strengthening the development of pediatric medicines in Europe, but there are still opportunities for further optimization. By addressing issues such as the scientific advice process, PIP development, compliance checks, and study submissions, efficiency can be improved.