#Ukraine #Kyiv #Maksym Bagrieiev #Cratia

The Impact of War on Ukraine's Health Regulatory Framework

In the wake of Russia's ongoing military aggression, Ukraine has experienced a significant transformation in its healthcare and regulatory systems. Maksym Bagrieiev, CEO of the regulatory consultancy firm Cratia, sheds light on how the war has unintentionally accelerated Ukraine's integration into the European health and regulatory landscape. His insights come from an in-depth article titled "How War Accelerated Ukraine's Integration Into the European Health and Regulatory Space."

The War as a Catalyst for Change

Following the Russian invasion in February 2022, Ukraine's healthcare infrastructure faced extreme challenges with over 1,900 medical facilities either damaged or destroyed. The war disrupted traditional supply chains for medicines and medical devices, leading to urgent shortages across the country. In response to this crisis, the Ukrainian government realized that aligning its legislative framework with European Union standards not only made sense but was essential for rebuilding its healthcare system.

Regulatory Relief Measures

Initially, the Ukrainian government implemented a range of temporary regulatory measures aimed at addressing the crisis:

• - Emergency importation protocols for unregistered medicines and devices were established.
• - Waivers for Good Manufacturing Practice (GMP) requirements allowed for faster access to necessary products.
• - Suspension of compliance deadlines alleviated the immediate regulatory burdens on healthcare providers.
• - Authorization for non-standard transportation of pharmaceuticals significantly expedited the distribution process.
• - Relaxation of quality control checks helped ensure that critical medical supplies reached those in need more quickly.

Additionally, the Ministry of Health coordinated the delivery of over 12,800 tons of humanitarian medical aid, valued at more than $350 million, from various partnering nations.

Moving Towards a European-Compatible Regulatory System

As stability returned to the region, Ukraine began to phase out its wartime regulatory exemptions and shift towards a more permanent system aligned with EU standards. This development signaled a proactive approach to health care reform rather than a mere return to former practices.

Key steps included the cancellation of emergency import waivers, reinstatement of compliance norms, and phasing out of expedited registration routes. This transition underscored a commitment to a robust regulatory environment, which was further bolstered by Ukraine's candidacy for EU membership declared in 2022.

Landmark Pharmaceutical Reforms

Central to this reformation was the introduction of the newly enacted Law on Medicinal Products, which took effect in 2023 and closely follows EU Directive 2001/83/EC. Key provisions of this law include:

• - The establishment of a centralized regulatory authority, akin to EU agencies.
• - Adoption of the eCTD (electronic Common Technical Document) format by August 2025 for new applications.
• - Implementation of GS1 DataMatrix serialization and anti-tampering features by 2028.
• - Recognition of EU-origin medicines without requiring re-testing upon import.

Notably, Ukraine has also introduced pricing controls for medicines, ensuring that distribution and pharmacy markups are regulated.

Compliance in Medical Devices

In the medical device sector, Ukraine currently operates under outdated EU directives but has committed to achieving full compliance with EU Regulations MDR (2017/745) and IVDR (2017/746) by 2025. This transition will include a ten-year transitional period for manufacturers, simplifying the recognition of existing EU-issued certificates and upholding the legality of current Ukrainian conformity until full implementation.

New Frameworks for Cosmetics and Chemicals

In August 2024, Ukraine adopted a new Technical Regulation on cosmetic products, mirroring EU Regulation 1223/2009. This regulation mandates the use of safety assessments and the designation of a local Responsible Person for product compliance.

Moreover, a new Chemical Safety Regulation, modeled on EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), has been implemented, requiring registration of chemical substances by January 2026.

Cratia: Navigating the New Landscape

As a key player in this transformative period, Cratia supports manufacturers in navigating the complexities of the new regulatory landscape. The firm, which operates across 11 countries, provides essential services to over 1,000 clients in pharmaceuticals, medical devices, cosmetics, and more.

As Bagrieiev stated, "Our role is to be a partner in transformation, helping international companies adapt to the new standards and maintain their access to the Ukrainian market as it aligns with the broader European framework."

Conclusion

Bagrieiev's insights illuminate how Ukraine's war-induced challenges have spurred a necessary and rapid transformation in its health regulatory landscape. As the country moves towards EU alignment, these reforms herald a new era of greater regulatory consistency and cooperation within Europe, showcasing resilience and strategic foresight in the face of adversity.

For more information and access to the full article, visit Cratia's website.