The safety of using various drugs in children is one of the main requirements for pharmacotherapy. The study of the effect of drugs (drugs) on the child’s body is extremely important, since they can have a negative impact on the growth and formation of a child and further affect the quality of life. Standard operating procedures (SOPs) and pharmacovigilance overseeing good pharmacovigilance practice are of particular importance here. The master file, generated by an organization that provides a full range of pharmacovigilance services, is the most important document on pharmacovigilance.

It should be borne in mind that drugs used in pediatric practice may have delayed safety problems that have not been identified in clinical trials. Pharmacodynamics and pharmacokinetics of drugs in children may have peculiarities, therefore, children should not be considered as adults with less body weight. Master files from companies providing a full range of pharmacovigilance services for firms holding registration certificates for medicinal products used in pediatric practice, and other documents on pharmacovigilance clearly demonstrate this. Pharmacovigilance Standard Operating Procedures (SOPs) provide a more complete and evidence-based safety profile for drug therapy for children. Good pharmacovigilance practice dictates the need for long-term post-marketing studies in each age group.

In this regard, good pharmacovigilance practice worldwide pays special attention to post-marketing monitoring of drug safety. Search and analysis of signaling information in the post-registration period of drug use in children, which is provided by organizations providing a full range of pharmacovigilance services, form a master file and other documents on pharmacovigilance. This increases the safety of pharmacotherapy in pediatric practice. Detection and analysis of signals on the safety of drug use in children are an obligatory part of pharmacovigilance practice. Pharmacovigilance standard operating procedures (SOPs) play a critical role in providing new information on the risks of pharmacotherapy in pediatric practice. According to the definition of the Guideline on good pharmacovigilance practices (GVP) in the member states of the Eurasian Economic Union, a signal is information that suggests a new causal relationship or a new aspect of a previously known relationship between drug exposure and an adverse event. This kind of information can come from various sources. Signals are processed during the following stages: identification, validation, analysis and prioritization, assessment of signal strength and significance at the medical level and development of recommendations for action and subsequent exchange of information.