Ukraine

The primary regulatory authority for health products in Ukraine is the State Expert Centre (SEC) of the Ministry of Health of Ukraine, which operates under the framework of the Law of Ukraine 'On Medicinal Products' (No. 123/96-VR) and related legislation covering medical devices and diagnostics. The SEC is responsible for conducting scientific expert reviews, issuing marketing authorizations, and maintaining state registers for pharmaceuticals, medical devices, and in vitro diagnostics. The general approval process involves submission of a regulatory dossier, scientific assessment by the SEC, and issuance of a registration certificate, which is typically valid for five years and subject to renewal. Medical devices are additionally governed by Cabinet of Ministers resolutions aligning with European Union directives on medical devices and IVDs.

Ukraine has been progressively harmonizing its regulatory framework with European Union standards, particularly through the EU-Ukraine Association Agreement, which commits Ukraine to adopting EU technical regulations and Good Manufacturing Practice (GMP) norms. Submissions generally follow the Common Technical Document (CTD) format for pharmaceuticals, and EU-aligned technical documentation requirements for medical devices and diagnostics. A local regulatory representative or authorized representative established in Ukraine is required for foreign manufacturers. Recent reforms have focused on accelerated registration pathways for products already approved by stringent regulatory authorities (SRAs) such as the EMA, FDA, and Health Canada, allowing for expedited review procedures. Wartime conditions since 2022 have further prompted emergency authorization mechanisms and simplified procedures for essential health products to ensure continuity of supply.

Public procurement of health products in Ukraine is centrally coordinated through the Ministry of Health of Ukraine, with a significant share of national procurement managed by the state enterprise 'Medical Procurement of Ukraine' (MPU), established to centralize and professionalize public health purchasing. National tender procedures are conducted in accordance with the Law of Ukraine 'On Public Procurement' and are published on the transparent electronic procurement platform ProZorro, which is mandatory for all public procurement entities. Budgetary allocations flow primarily from the central state budget, with regional health authorities and hospitals also conducting decentralized procurement for locally funded needs. The National Health Service of Ukraine (NHSU), responsible for implementing the medical guarantees program, plays an increasingly important role in reimbursement and contracting with healthcare providers.

Donor-funded and international procurement channels play a substantial role in Ukraine's health supply landscape, particularly given the ongoing conflict and humanitarian crisis. Organizations such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, WHO, and the International Renaissance Foundation have provided significant procurement support for essential medicines, vaccines, diagnostics, and medical devices. Ukraine participates in GAVI-supported immunization programs and benefits from pooled international procurement mechanisms for vaccines and health commodities. While there is no explicit blanket local manufacturing preference policy comparable to some markets, Ukrainian authorities have signaled policy interest in strengthening domestic pharmaceutical and medical device production capacity, with certain public procurement criteria and government programs designed to incentivize local industry development and reduce import dependency over the medium term.