The Eurasian Economic Commission (EEC) and the authorized bodies of the member states of the Eurasian Economic Union (EAEU) will follow the approaches of the World Health Organization (WHO) at all key stages of the medicine’ s life cycle, from preclinical studies and registration to pharmacovigilance, inspections and state control. The corresponding decision was adopted by the EEC Council on 9 July, BelTA learned from the EEC’s press service.
“Compliance with these standards is regarded by the WHO as one of the factors contributing to a high level of regulatory maturity. For the EAEU, this is not merely about aligning national procedures with international standards but about creating a transparent and predictable regulatory framework,” the EEC said.
“The establishment of a common good regulatory practice framework is a strategic step. It is not simply a technical revision of documents but the creation of a competitive environment with clear and stable conditions for businesses and citizens,” Aleksandr Subbotin, member of the EEC Board, Minister in charge of Technical Regulation, said as he commented on the decision.
The new framework is based on nine principles that will guide the work of the EEC and national regulators: legality, consistency, independence, impartiality, proportionality, flexibility, clarity, effectiveness and transparency.
“The introduction of these standards is expected to provide a strong boost to the pharmaceutical industry across the EAEU. The key benefits will include greater export potential, increased confidence in medicines manufactured in the union’s member states, further development of the common pharmaceutical market, improved regulatory mechanisms, and stronger international cooperation and partnerships,” the press service added.
Deputy Prime Minister Natalya Petkevich serves as Belarus’ representative in the EEC Council.
