Changes to the EAEU rules, which introduce the concepts of RWD and RWE, may be considered by the Board of the Eurasian Economic Commission at the beginning of next year. It is planned that at the first stage it will be possible to use the RWE data when making changes to the registration dossier for the drug.

A draft document that will establish the concepts of real-world data (RWD) and evidence obtained from real-world evidence (RWE), the Board of the Eurasian Economic Commission may consider in the first quarter of 2022. Changes are being made to the EEC Decision No. 78 "On the rules for registration and examination of medicines for medical use." This was announced by Anna Kravchuk, Deputy Head of the Department for Coordination of Work in the Sphere of Circulation of Medicines and Medical Devices of the Department of Technical Regulation and Accreditation of the EEC, at the Forum "Clinical Trials in Russia 2021".

“So that these terms do not just hang in the air, they could be applied in a targeted manner, and as a result of this practice, some further regulatory decisions could be made, we have now agreed on the use of these data in the section on making changes to the registration dossier,” Kravchuk explained. She added that data for all indications and for all groups of patients can be used, regardless of their inclusion in the registration dossier.

According to Kravchuk, the project has already passed the regulatory impact assessment and is now undergoing legal expertise.

The Working Group on the formation of common approaches to the regulation of the circulation of medicines within the EAEU approved amendments that introduce the concepts of RWD and RWE in August this year.

In parallel, the revision of the rules of good pharmacovigilance practice is being updated, Kravchuk added. According to her, the changes have already passed public discussions and it is planned to submit them for consideration by the EEC in the next half of the year.

Changes, in particular, relate to comments on the definition of post-marketing safety studies. “It will be additionally noted that post-marketing safety studies include both interventional clinical trials and non-interventional design studies, including those using data from real clinical practice. Accordingly, these data are already receiving primary regulation within the framework of the EAEU common drug market, ”Kravchuk explained.

The expert also pointed out the need to develop new tools for processing the received data.

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