The State Expert Center of the Ministry of Health of Ukraine successfully passed the recertification audit of the quality management system and received a certificate. Its results confirmed that the Center's quality management system meets the requirements of the international standard ISO 9001:2015.
The confirmation of compliance certifies that the Center operates under clearly defined procedures, systematically improves internal processes and applies modern management approaches. This ensures stability and consistency of work, which is especially important during the transformation of Ukraine's regulatory system and its approximation to European requirements.
This year, the scope of the Center's certification has been expanded – for the first time it includes laboratory testing of medicinal products.
Thus, the Center's management system is certified in the following areas of activity:
- expert services in the field of preclinical study, clinical trials and state registration of medicinal products;
- laboratory testing of medicinal products;
- performance of pharmacovigilance;
- health technology assessment;
- services in the field of standardization of medical care and medical, including pharmaceutical, services.
During the audit, development since the previous certification in 2023 was also assessed. During this time, key documents were updated, management processes were improved, and a number of organizational changes were implemented. The majority of the changes were implemented in 2026.
In particular, the Strategic Development Plan of the Center until 2028 was approved, the Quality Policy and objectives, the Code of Ethics for employees, documents defining management responsibilities, the Charter and organizational structure of the Center were updated, and more than 100 standard operating procedures were revised.
Among the important organizational changes is the introduction of the compliance function and the creation of a corresponding department to strengthen mechanisms for preventing conflicts of interest and managing compliance risks. A Department of Standardization of Pharmaceutical Activities was also established as a step toward implementing good pharmaceutical practices.
The laboratory area has also been strengthened. The Pharmaceutical Analysis Laboratory of the Center underwent an external audit by the State Service of Ukraine on Medicines and Drugs Control and received a Certificate of Attestation.
At the same time, the Center continues to implement European approaches to regulatory activity. In particular, the Center's specialists are taking part in the Twinning project aimed at supporting the establishment in Ukraine of an independent state control body in the pharmaceutical sector in accordance with European Union standards.
Reference information. ISO 9001:2015 is an international quality management system standard applied by more than a million organizations in 189 countries. The standard sets out requirements for managing processes, their continuous improvement and focus on customer needs. In the healthcare sector, ISO standards help improve patient safety, foster innovation and strengthen trust in the organization.
We would like to remind that the Center has maintained a quality management system in accordance with the requirements of ISO 9001:2015 since 2014.
The next step is preparation for certification of the compliance management system under the international standard ISO 37301.
