How war accelerated Ukraine’s integration into the European health and regulatory space

Despite the devastation of war, Ukraine is implementing sweeping pharmaceutical, medical device, and chemical safety reforms aimed at approximating its legislation and practices with EU standards. 

When Russia launched its full-scale invasion in 2022, Ukraine’s healthcare infrastructure and supply chains came under immediate threat. Hospitals were destroyed, logistics disrupted, and critical shortages of medicines and medical devices emerged. Yet, even in this crisis, Ukraine remained committed to its strategic direction — toward integration with the European Union. The war didn’t slow reform — it accelerated it. 

This article examines how the war has accelerated Ukraine’s integration with the EU’s regulatory framework for pharmaceuticals, medical devices, cosmetics, and chemical safety.

War as a catalyst for regulatory change

Governments often focus solely on survival during war. But in Ukraine, the war has also acted as a catalyst for deep systemic change, particularly in the healthcare and regulatory sectors.

When the full-scale invasion began in February 2022, Ukraine’s health system was under siege. More than 1900 healthcare facilities were damaged or destroyed. Pharmaceutical warehouses and distribution hubs were targeted. Traditional supply routes – often reliant on regional logistics and seaports – became inaccessible or unsafe.

To avoid a catastrophic shortage of medicines and medical devices, the Ukrainian government swiftly introduced emergency regulatory simplifications. These included:

• Temporary permission to import and use unregistered medicines and medical devices,
• Emergency authorization route for vital medicinal products; 
• Waivers for Good Manufacturing Practice (GMP) documentation during importation,
• Suspension of compliance deadlines for marketing authorization holders,
• Permission to transport products outside licensed pharmaceutical logistics channels.

These actions ensured uninterrupted access to critical treatments, especially in frontline regions. But they also opened a parallel track: humanitarian supply. The Ministry of Health coordinated with local and international donors to cover urgent needs. By 2024, Ukraine had received over 12,800 tons of humanitarian medical aid valued at more than 13.5 billion UAH (~350 million USD) from 35 countries, international organizations, NGOs, and private-sector donors.

Rather than becoming dependent on emergency relief, Ukraine used this time to prepare for a return to structured, EU-aligned regulation. By mid-2023, as the health system began to stabilize, the government began phasing out wartime flexibilities:

• The emergency import mechanism for unregistered products was revoked,
• GMP documentation again became mandatory,
• Expedited registration routes were gradually discontinued.

Crucially, this rollback didn’t mark a return to the past, but a leap into the future. With Ukraine’s formal EU candidacy status granted in 2022 and renewed momentum for accession in 2024, the government committed to accelerating legal harmonization with the EU acquis. In the health sector, this meant not just adopting European rules but building the institutions, digital infrastructure, and technical standards required to enforce them.

The regulatory ecosystem emerging in wartime Ukraine is more resilient, transparent, and aligned with global best practices than ever before. Far from halting progress, the war has intensified Ukraine’s regulatory transformation – and made its European future not just aspirational, but operational.

Pharmaceutical reform: from emergency relief to eCTD and centralized control

The pharmaceutical sector in Ukraine has undergone substantial regulatory transformation since the onset of the full-scale war. While initial emergency measures were introduced to maintain market supply during wartime disruption, the country has since transitioned to implementing structural reforms aligned with European Union legislation.

As conditions gradually stabilized, the Ukrainian government began phasing out temporary relief mechanisms. Simultaneously, long-planned reforms resumed with increased urgency as part of the country’s broader alignment with the EU. One of the core milestones was the adoption of the new Law “On medicinal products”, which came into force in 2023 with the gradual implementation of its provisions, up to Ukraine’s accession to the European Union. This legislation was developed based on EU Directive 2001/83/EC, aiming to approximate marketing authorization, manufacture, importation and distribution, advertising, market supervision, and post-marketing requirements to the acquis EU. 

Key changes include:

• Establishment of a centralized regulatory authority, responsible for marketing authorization, clinical trial oversight, pharmacovigilance, GMP/GDP/GCP inspections, market surveillance, and intended to function as a national counterpart to the European Medicines Agency (EMA). 
• Mandatory use of the eCTD format for all new marketing authorization applications starting August 2025. 
• Introduction of serialization requirements, with mandatory application of GS1 DataMatrix unique identifiers and tamper-evident devices on all prescription medicines by January 1, 2028. 
• The marketing authorization holder should be either a resident of Ukraine, a resident of the EU, or an EFTA. 
• Medicines from the EU and EFTA are excluded from the definition of import and from the point of view of quality control, equated to distribution. 

As part of its broader alignment with EU market principles and in response to growing concerns over medicine affordability during wartime, Ukraine has also introduced structured pricing mechanisms. Implementation of a new pricing regulation in February 2025, including the creation of a National Price Catalogue and reference pricing system. Distributors are limited to a maximum 8% markup, pharmacies are subject to a regressive scale from 10–25% for prescription products, and generic medicines are capped at 75% of the originator’s declared price. Manufacturers and importers are required to declare prices that do not exceed the calculated reference price based on the average of the three lowest prices in designated countries.

Medical devices: stepping toward MDR and IVDR alignment

While emergency conditions during the war necessitated certain procedural flexibilities, the underlying regulatory development has continued under the goals initially outlined in the EU-Ukraine Association Agreement.

Currently, Ukraine applies technical regulations based on the EU’s previous medical device directives, namely 93/42/EEC, 98/79/EC, and 90/385/EEC. These were implemented through national legislation in 2013 and continue to serve as the primary legal framework for device conformity assessment. Notably, Ukraine has introduced a simplified procedure for the recognition of CE certificates issued by EU Notified Bodies under both the former directives and the new MDR/IVDR regulations.

In 2025, the Ukrainian government is expected to adopt new Technical Regulations aligned with Regulation (EU) 2017/745 on medical devices, and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The forthcoming regulations are anticipated to include transition periods of up to 10 years, allowing gradual adaptation by manufacturers, conformity assessment bodies, and healthcare institutions. During this time, the current regulatory system will remain operational, maintaining legal continuity and minimizing disruption to market access.

Ukraine’s dual-track approach to recognition of both legacy MDD/IVDD/AIMDD and new MDR/IVDR certificates allows for a pragmatic transition. It also provides international manufacturers with a predictable framework for introducing medical devices into the Ukrainian market while broader legislative convergence continues.

Beyond regulation, the country’s medical device policy has also adapted to address wartime needs, particularly in the area of rehabilitation technologies. Ukraine continues to enhance the reimbursement system, making it more patient-friendly and transparent, as outlined in the latest CMS report. In response to the growing number of civilians and military personnel affected by injury or amputation, the government increased funding for assistive and prosthetic devices under the national disability support program. In 2024 alone, more than 6.7 billion UAH (app. 160 mil. USD) was allocated to the Ministry of Social Policy for these purposes.

In addition, Ukraine has seen the development of specialized clinical and rehabilitation centers, such as Superhumans, established in partnership with international donors and private foundations, including Howard Graham Buffett, Virgin, Mastercard, and Unbroken supported by South Korea, Germany and Japan under UNDP programs as well as other NGO’s, governments and private donors. These institutions aim to provide long-term rehabilitation, advanced prosthetics, and psychological support for victims of war, and are expected to serve as models for integrated post-war recovery infrastructure. 

Cosmetics and chemicals: new laws with EU DNA

In addition to reforms in the pharmaceutical and medical device sectors, Ukraine has introduced significant regulatory changes in the areas of cosmetic products and chemical safety. These efforts form part of a broader legal approximation process under the EU-Ukraine Association Agreement and reflect Ukraine’s commitment to adopting the principles of the European Union’s internal market legislation.

On August 3, 2024, Ukraine’s new Technical Regulation on Cosmetic Products entered into force. The regulation is based on EU Regulation (EC) No 1223/2009 and introduces a framework for ensuring product safety, transparency, and traceability in the cosmetic industry.

Key features of the regulation include:

• Designation of a Responsible Person (RP) residing in Ukraine, who assumes legal responsibility for product compliance;
• Mandatory preparation of a Cosmetic Product Safety Report (CPSR) by a qualified national safety assessor;
• Compilation of a Product Information File (PIF) to support safety and efficacy claims;
• Electronic notification of cosmetic products via the portal administered by the Ministry of Health.

The regulation includes a two-year transition period, with full compliance required by August 3, 2026. During this period, manufacturers and importers are expected to bring their products into conformity with the new technical requirements. 

These reforms are designed to improve market oversight, facilitate traceability of products, and align the Ukrainian cosmetics market with EU standards.

On January 26, 2025 a new Technical Regulation on the Safety of Chemical Products came into force, which was developed on the basis of the EU REACH Regulation (EC No 1907/2006). The regulation applies to all chemical substances imported, manufactured, or marketed in Ukraine.

New Regulation is implemented with transitional periods up to 5 years, with earlier deadlines for carcinogenic, mutagenic, and reproductive toxicants (CMRs) and high-volume substances. To benefit from the transitional periods, it is required to pre-register substances by January 26, 2026. 

The regulation applies not only to standalone substances but also to substances contained in mixtures and finished products (such as cleaning agents, paints, or industrial inputs). It aims to improve environmental and human health protection, strengthen the traceability of chemical substances, and ensure compatibility with the EU regulatory model. 

The success of implementation will depend on the capacity of local manufacturers and importers to adapt, as well as the ability of authorities to develop operational infrastructure and guidance tools. Already, several business associations addressed concerns to the Ministry of Environmental Protection and Natural Resources of Ukraine regarding short pre-registration and transitional timelines.

Ukraine is not waiting for peace to shape its future. The war has accelerated reforms that might have otherwise taken a decade. While the human toll is incalculable, the policy response is clear: a firm commitment to European standards, transparency, patient safety, and market integration. The healthcare system that emerges from this crisis will be not only more resilient, but also more European.

Maksym Bagrieiev
CEO of Cratia