News

26.05.2022 (Обновлено: 14.06.2022 10:37)

The EAEU optimizes the procedures of adopting technical regulations and simplifies marketing authorization of medicines

"Ensuring the safety of medical products, their access to and circulation in the market of the Eurasian Economic Union have always been and remain a focus of attention for government entities as well as business and expert communities of our countries," Viktor Nazarenko, Minister in charge of Technical Regulation of the Eurasian Economic Commission, emphasized during the meeting of the round table held on May 25 at the Ministry of Economy and Commerce of the Kyrgyz Republic as part of events timed to coincide with the Eurasian Economic Forum in Bishkek.
The participants of the round table discussed the current state and development prospects of the technical regulation system, as well as the establishment of common markets for medicines and medical products.
Timur Nurashev, Director of the Commission's Technical Regulation and Accreditation Department, spoke about improving the Union law and particularly about adopting new versions of procedures for development and adoption of technical regulations and lists of standards thereto, the new procedure for importation of products into the Union territory, and approaches to harmonizing the principles of the Member States' supervisory activities. According to Timur Nurashev, a lot of work has been completed to optimize the procedures of adopting technical regulations. "The development time has been reduced by 170 days, that is 36%. The duration of the new procedure will be at least 302 days as compared to 472 days according to the current procedure," he noted.

The expedited procedure should be applied for making amendments to the technical regulation of the Union in terms of specification (uniform application) of its provisions in case of any issues with individual provisions.

"To speed up the possibility of using modern standards to apply the EAEU technical regulations, lists of standards may in exceptional cases be amended under the expedited procedure, without public discussion or review at the meeting of the advisory committee, including in case of approving interstate standards in accordance with their development programs," Director of the EEC Department emphasized.

Chinara Mambetalieva, Deputy Director of the Commission's Technical Regulation and Accreditation Department, spoke about innovations in the field of circulation of medicines and medical products. She noted that changes concerned expanding the possibility for electronic document flow, performing remote procedures during the quality assessment of medicinal products, and simplifying the access of highly efficient and orphan medicines to the Union market.

"Decisions taken to simplify the procedures of marketing authorization of medicines for circulation only in the market of a single country simplify patient access to drugs in case of emergency threats, as well as patient access to groups of breakthrough and advanced therapy medicinal products and orphan medicines," Chinara Mambetalieva noted.

Moreover, on May 25, Viktor Nazarenko, EEC Minister in charge of Technical Regulation, delivered a lecture for the students and teachers of the Kyrgyz State Technical University named after I. Razzakov where he highlighted the main aspects of the unified technical regulation system in the EAEU and replied to numerous questions of students.

 Information Support Section of the EEC Organizational Support and Protocol Department