The Board of the Eurasian Economic Commission has adopted Guidelines for the preparation of Documentation on Chemical and Pharmaceutical Quality for Medicines used in Clinical Trials.
The guidelines will allow to unify approaches to ensuring the quality of medicines used in clinical trials and to exclude harm to the life and health of patients. Regulate the amount of information provided to medical researchers, independent ethics committees and authorized bodies in the field of healthcare for the proper handling of the drug. To ensure continuity of data on the quality of the drug released in the series for clinical trials and in subsequent series of the drug released to the market.
“The adopted guidelines will allow to establish uniform approaches to the preparation of documentation on chemical and pharmaceutical quality in the dossier of medicines used in clinical trials. This dossier is submitted to the authorized bodies of the member states to obtain permission to conduct a clinical trial with human participation,” said Viktor Nazarenko, Minister for Technical Regulation of the EEC.
A source: Press Service of the EEC
