At the meeting of the EAEU Expert Committee on Pharmaceuticals, chaired by EAEU Minister of Technical Regulation Alexander Subotin, several regulatory act projects were approved and proposed for consideration by the Commission's Collegium:
For the first time, a project for organizing and conducting microbiological monitoring of the production environment was developed in the form of a directive, aimed at manufacturers of sterile and non-sterile medicines, which will ensure the harmonization of approaches used in this area among the member states of the Eurasian Economic Union:
Additionally, changes to the rules for conducting bioequivalence studies of medicines within the EAEU were approved, allowing the use of model systems (artificial membranes) for assessing the bioequivalence of gels, ointments, and other topical forms:
This will enable the replacement of expensive and complex studies conducted using donor skin with modern alternative technological methods:
Another project approved by the committee proposes changes to the rules for the registration and examination of medicines for medical use. It establishes a unified approach to the naming of active substances (International Nonproprietary Name (INN), commonly accepted, group, or chemical name) in application forms and the unified register of registered medicines:
Alexander Subotin thanked the experts from the member states of the Union for their thorough preparation of the documents, which allowed for consensus on the issues discussed:
The mentioned projects are expected to be discussed at the meetings of the Collegium of the Eurasian Economic Commission in August, September, and October of this year:
