The future of drug registration in the EAEU - direct answers from CEHI
Recently, PharmAssistance LLC held a closed meeting with experts from the Ministry of Health of the Republic of Belarus. This allowed us to gain direct access to the regulator's plans and be the first to hear, what steps the market expects in the near future. We share with you the most important things.
At the meeting, key decisions were made on the future of drug registration in the EAEU and Belarus:
– Strategic drugs — national registration of strategic drugs is maintained: RU is issued to 5 years, further after confirmation - unlimited. Also, in the near future it will be possible to transfer drugs to strategic status by the end of this year.
– Terms of “bringing into compliance” - to 31.12.2025, later only new registration according to the rules of the EAEU. If the application for referral is withdrawn/refused after this date, the national RU will cease to be valid on the same day.
– National RU – are automatically renewed upon submission and acceptance applications for bringing to 31.12.2025 (without filing a dossier). Regulators will exchange data and enter all information into the register early next year, but it is recommended to check the data yourself and report possible discrepancies.
General mood of the regulator: pragmatic and confident, without promises of radical relief. There is little time - key steps need to be completed 2025 of the year.
We closely monitor changes and are ready to help companies successfully implement projects.

