Russia: Draft guideline for the pharmaceutical development of medicinal products for use in paediatric practice

 

Russia has published a Draft guideline for the pharmaceutical development of medicinal products for use in paediatric practice.

The draft guideline on the pharmaceutical development of medicines for use in paediatric practice provides for the need to establish unified approaches to the process of pharmaceutical development of medicines for use in paediatric practice to create safe and high-quality medicines intended for use for the paediatric population, to provide additional guarantees of a favourable benefit-risk ratio for this critical group of patients, and the possibility of their adequate use by children of different age groups and not creating an unnecessary burden on patients and (or) persons providing care for them.

The Guidance contains additional requirements on pharmaceutical drug development for children from birth to 18 years of age. The Guide should be considered in conjunction with other acts of the Eurasian Economic Union in the field of drug circulation.

The most important tasks for drug development drugs for children appropriate for their age are to provide children of the target age group (groups) with drugs of stable quality with a positive benefit-risk ratio, their adequate susceptibility by patients and not creating an unnecessary burden on patients and (or) persons providing care for them.

The physical, metabolic and psychological processes inherent in the growth of children from birth to adulthood indicate that children cannot be considered as small adults and also as a homogeneous group. As a consequence, clinical trials in adults are not necessarily predictive for children. Therefore, in many cases, in order to confirm the safety and efficacy of a drug for all age groups of children, clinical studies are conducted involving children of all age groups. In addition, the treatment of children with drugs creates specific pharmaceutical problems that may depend on age (eg, infants cannot swallow standard size tablets, neonates may require very small volumes of parenteral drug to avoid volume overload, etc.). Therefore, children should take age-appropriate medications that are pharmaceutically designed to be appropriate for their intended use in the target age group(s).

The full text of the Guidance is available on the website of the Eurasian Economic Union: HERE