It is impossible to fully assess the safety profile of a new drug based only on clinical studies conducted for the purpose of subsequent registration of the drug. FN allows health authorities to continuously assess the balance of benefits and risks throughout the entire life cycle of a drug and makes it possible to identify rare and serious adverse reactions that were not detected before the drug was registered. Regulatory requirements for pharmacovigilance also allow the identification of new safety signals related to the quality of the drug and / or changes in the actual practice of drug use and prescription. For this to be possible, it is important to establish a reliable national PV system.

The reliability of the FN system is largely dependent on consistent, thorough and accurate data collection and subsequent analysis of adverse reaction (AD) reports. Without such a solid foundation, it is impossible to identify drug safety signals, as they can be latent, disordered and blurred. It is necessary to collect data on adverse reactions for each drug around the world so that the identification and analysis of safety signals is possible through the collaboration of national pharmacovigilance systems. To this end, the WHO International Medicines Monitoring Program and the Uppsala Monitoring Center were established in 1978. The main regulatory requirements for pharmacovigilance were also described there.

Basic principles that are met by regulatory requirements for pharmacovigilance. All medicines can cause adverse reactions (ADRs). Biotherapeutic drugs have unique characteristics due to their biological nature and complex structure, which requires individual monitoring of adverse reactions. Some cases can be so rare that they cannot be detected at the stage of pre-registration clinical trials; subsequently, they can lead to the development of adverse reactions or even to a decrease in the effectiveness of the drug.