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27.12.2022 (Обновлено: 17.01.2023 16:41)

EAEU unifies approaches to quality assurance of medicines used in clinical trials

The Board of the Eurasian Economic Commission adopted the Guidelines for documenting chemical and pharmaceutical quality of medicines used in clinical trials.

 

The Guidelines allow to unify approaches to quality assurance of medicines used in clinical trials and prevent harm to lives and health of patients. The document regulates the amount of information provided to physicians doing research, independent ethics committees and authorized healthcare bodies to ensue proper handling of pharmaceuticals. Continuity of data on quality is maintained when a medicine is produced in a series for clinical trials and in subsequent series for the market.

 "The adopted Guidelines will allow to establish unified approaches to documenting chemical and pharmaceutical quality in dossiers of medicines used in clinical trials. Such dossier is submitted to authorized authorities of Member States to obtain a permit for conducting a clinical trial involving humans," noted Viktor Nazarenko, EEC Minister in charge of Technical Regulation.