European integration of the Ukrainian pharmaceutical industry. International experience exchange. The role and importance of the State Service of Ukraine on Medicines and Drugs Control

On February 20, 2025, a meeting with European medicinal agencies was held at the Ministry of Health of Ukraine.

The main topics of the meeting were the reformation of Ukraine’s pharmaceutical sector in the context of establishing the National Regulatory Authority (NRA) – a unified multifunctional state regulatory authority, as stipulated by the Law of Ukraine “On Medicinal Products” No. 2469-IX dated July 28, 2022 – as well as the general principles of European integration for the Ukrainian pharmaceutical industry and the reformation of industry legislation.

The international participants of the meeting included representatives:

• Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland;
• Swedish Medical Products Agency;
• Danish Medicines Agency;
• National Agency for the Safety of Medicines and Health Products of France (ANSM);
• Agency for Medicinal Products and Medical Devices, Croatia (HALMED).

The Ukrainian side was represented by Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control, and Mykhaylo Babenko, Director of the State Enterprise “State Expert Center of the Ministry of Health of Ukraine”.

In his presentation, Roman Isaienko presented a multi-level system of control over the medicines circulation in Ukraine, in which the State Service of Ukraine on Medicines and Drugs Control plays a key role in ensuring the quality and safety of medical products, as it is the specialized central executive authority in ensuring state control over the medicines quality, licensing their manufacture and import, as well as implementing mechanisms for rapid response to threats related to the falsification of medicines.

Currently, 25 regional authorities of the State Service of Ukraine on Medicines and Drugs Control are conducting quality control of medicines and medical devices at the local level.

Three state enterprises that are managed by the State Service of Ukraine on Medicines and Drugs Control:

• SE «Central Laboratory for Drugs Quality Analysis and Medicinal Products»
• SE «Ukrainian Pharmaceutical Quality Institute»
• SE «The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» (Pharmacopoeial Center).

Five authorized laboratories have been empowered by the State Service of Ukraine on Medicines and Drugs Control to conduct quality control of medicines.

The State Service of Ukraine on Medicines and Drugs Control cooperates on an ongoing basis with the National Police of Ukraine, the Security Service of Ukraine, the State Border Guard Service of Ukraine, and the State Service of Ukraine on Food Safety and Consumer Protection to effectively detect and prevent the circulation of substandard medicines.

The State Service of Ukraine on Medicines and Drugs Control also exchanges information within the WHO Surveillance and Monitoring System (GSMS) on substandard and counterfeit medical products that pose a threat to the population.

In 2011, Ukraine, represented by the State Service of Ukraine on Medicines and Drugs Control, became a member of the PIC/S. In 2018, the State Service of Ukraine on Medicines and Drugs Control passed the standard reassessment for compliance with PIC/S requirements and received a positive assessment.

Inspectors of the State Service of Ukraine on Medicines and Drugs Control are included in the international register of PIC/S GMP inspectors.

The annual training program for GMP/GDP inspectors is harmonized with the PIC/S and EU requirements, ensuring constant development and maintaining the appropriate knowledge level of GMP/GDP inspectors

Key areas of work in the context of European integration processes:

• expert evaluation and development of regulations in accordance with EU legislation;
• strengthening institutional capacity;
• training of inspectors according to European standards GMP/GDP;
• introducing a risk-based approach to inspections;
• developing of electronic tools for monitoring compliance with standards;
• creating a single portal for interaction with applicants;
• use of medicines tracking system (Track & Trace);
• creation of a single platform for interaction with law enforcement agencies, customs and border services;
• creation mechanisms for rapid response to threats of counterfeiting medicines.