On July 17, at a meeting chaired by Alexander Subbotin, the EEC Minister in charge of Technical Regulation, the Eurasian Economic Commission’s Expert Committee on Medicines approved draft regulatory acts and recommended them to the Commission’s Board for consideration.

First developed as a recommendation, the draft Guidelines for Organizing and Conducting Microbiological Monitoring of the Production Environment for Manufacturers of Sterile and Non-Sterile Medicinal Products will harmonize the approaches of the Eurasian Economic Union countries in this field.

Furthermore, the meeting approved amendments to the Rules for Conducting Bioequivalence Studies of Medicinal Products within the EAEU, allowing the use of model systems (artificial membranes) to study the bioequivalence of gels, ointments, and other topical dosage forms. This will enable replacing the expensive and complex procedure of studies using donor skin with an alternative, technologically advanced method.

The draft amendments to the Rules for Marketing Authorization and Expert Examination of Medicines for Human Use, as approved by the Committee, envisage a unified approach to specifying the names of active ingredients (INN, common name, group name, or chemical name) contained in a medicinal product in application forms and in the Unified Register of Registered Medicines.

Alexander Subbotin praised the Union States' experts for their thorough study and detailed elaboration of the documents, which enabled reaching a consensus on the issues under consideration.

These drafts are scheduled to be reviewed at the EEC Board's meetings in August, September, and October this year.