The Board of the Eurasian Economic Commission (EEC) has approved one of the key guidelines for studying the safety of medicinal products introduced into circulation in the territory of the Eurasian Economic Union. The press service of the EEC reports.
The document reflects the planning and organization of pharmacological safety studies with the participation of humans and animals, determines the volume and key targets in organs and tissues of the body for which the safety of the drug must be proved.
The guidelines stress the need to study the safety of both the active substance of the drug itself and the metabolites formed from it in the human body.
«A separate section of the document is devoted to the study of the safety of drugs in relation to heart rate and the ability to cause arrhythmia. Currently, special attention is paid to the assessment of the arrhythmogenic effect of drugs, since over the past decade several promising drugs have been withdrawn from circulation due to their negative impact on the heart rate,» the EEC noted.
The guidelines approved by the board of the commission were prepared on the basis of similar documents of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and are fully harmonized with them.