Within the framework of the Eurasian Economic Union (EAEU), since March 27, 2022, the concepts of "real-world data" (RWD) and " real-world evidence" (RWE) have been officially introduced.

"Real-world data" means data relating to a patient's health status and/or health care delivery process obtained from a variety of sources.

 "Real-world evidence" means clinical evidence regarding the use and potential benefit or risk of using a medicinal product based on the collection and analysis of real clinical practice data.

 The concepts were developed and proposed by the Association of Specialists in the Field of Health Technology Assessment, the Interregional Public Organization "Association of Clinical Pharmacologists", and the Law Office « Trubor».

Previously carried out:

• Questioning of the Ministries of Health of the members of the Union;
• Analytical research on existing and possible approaches to regulating the collection, analysis and use of data from real clinical practice in the Russian Federation;
• Formed proposals for changing the regulatory legal framework of the EAEU based on an analysis of the US experience in terms of regulating the use of data from real clinical practice to support regulatory decision-making.

Source: Decision of the Council of the Eurasian Economic Commission dated March 17, 2022 N 36 "On Amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use"

http://www.consultant.ru/document/cons_doc_LAW_411976/