The Ukrainian pharmaceutical sector is undergoing a large-scale transformation driven by European integration and the transition to European approaches in state registration, expert evaluation and pharmacovigilance of medicinal products.
Olena Semenchenko, PhD, Deputy Director of the State Expert Center of the Ministry of Health of Ukraine for Registration, Pharmacovigilance and Audit, spoke to Pharmaceutical Practitioner magazine about the key changes for the pharmaceutical market, their significance for patients and manufacturers, and the immediate priorities of the regulatory reform.
According to her, European integration is not only a change of legislation but also a transition to European standards of assessment and registration of medicinal products. In particular, the new Law of Ukraine "On Medicinal Products" provides for updating regulatory procedures, introducing modern digital tools and new approaches to working with registration dossiers. One of the key areas is the transition to the electronic eCTD format, which is expected to simplify document flow and interaction between the applicant and the regulatory authority.
At the same time, harmonization with European rules should bring concrete benefits to patients and the professional community. The introduction of a unique identifier and 2D-coding of packaging will help strengthen protection against falsified medicinal products. For pharmacists, the National System for Verification of Medicinal Products will become an additional tool for verifying authenticity.
At the same time, the principles of scientific evaluation of the quality, safety and efficacy of medicinal products do not change. Experts of the Center have been working in accordance with Ukrainian, European and international guidelines for many years. The main changes concern regulatory procedures – standardization, digitalization, efficiency and transparency.
Among the immediate priorities are completing the formation of the regulatory framework for the implementation of the new Law of Ukraine "On Medicinal Products", updating state registration procedures, developing digital tools and further harmonizing the pharmacovigilance system with EU requirements. The Center is also working on a draft of amendments to the Procedure for Conducting Expert Evaluation and practical recommendations for applicants.
"We are building a system that will operate according to clear, predictable and transparent rules, the same for Ukrainian and European manufacturers," emphasized Olena Semenchenko.
Read the full interview in the journal "Pharmacist Practitioner" at the link https://surl.li/lrkecw
