AVAILABILITY OF MEDICINES FOR CHILDREN: ISSUES OF REGULATORY IMPROVEMENT

Abstract

Objective: to analyze the factors limiting the availability of medicines for children and to substantiate directions for regulatory improvement in the Russian Federation. Materials and methods: a narrative (targeted) review of WHO documents, legal and regulatory acts of the EU, USA, China, Russia and the EAEU, as well as scientific publications. Results: availability is limited by the deficit of pediatric clinical data, the lack of age-appropriate formulations, incomplete labeling and weak market incentives. Russian regulation remains general and performs a compensatory function. Conclusions: a transition to an integrated proactive model for regulating the development, marketing authorization and circulation of medicines for children is required. This model should include prioritization of unmet needs, planning for the generation of pediatric data, support for the development of age-appropriate formulations, dedicated mechanisms for the registration of pediatric indications and labeling updates, and monitoring of actual availability.