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Regulations and guidelines

Pediatric clinical trials are subject to stringent regulatory frameworks and ethical principles, underscored by the societal imperative to safeguard the welfare of children. Given their vulnerable status, children necessitate meticulous protection from undue risks and stress during clinical research endeavors. Furthermore, their legal status as minors necessitates acknowledgment; children rely on their guardians and lack the capacity to comprehensively evaluate the implications and potential stressors associated with clinical trials.

A pivotal legal milestone is the enactment of the EU Pediatric Regulation (2007), applicable across all European Union member states. This regulatory framework aims to foster the development of more tailored, evidence-based, and safer pharmaceutical products for pediatric use, thereby addressing longstanding therapeutic gaps.

The European Medicines Agency (EMA) plays a pivotal role in enforcing the Regulation. Pharmaceutical enterprises are obligated to present a pediatric investigation plan (PIP) to the EMA's Pediatric Committee for each novel medicinal product, unless an exemption (waiver) is authorized.

Since it was instated, the Pediatric Regulation has had a positive impact on pediatric drug development, having resulted in greater availability of medicines for children in the EU.