Timely and high-quality processing of applications for compliance of medicines manufacturing conditions with good manufacturing practice (GMP) requirements is a key prerequisite for the sustainable supply of high-quality medicines to the population, as well as for the development of their export and use.
In 2025, the State Service of Ukraine on Medicines and Drugs Control processed a significant number of requests from business entities:
626 applications for conclusions confirming the compliance of medicines manufacturing conditions with good manufacturing practice (GMP) requirements were submitted and 729 conclusions were issued, including those concerning reissuance and extension of their validity.
123 applications for certificates of compliance of medicines manufacturing conditions with GMP requirements have already been processed, including 44 applications from Ukrainian manufacturers and 79 applications from non-resident manufacturers. 98 inspections have already been conducted for the purpose of certification of medicines manufacturing conditions. This includes manufacturers located in frontline territories. Among foreign manufacturers, the most frequent applicants were companies from Asia (India, Pakistan, South Korea, Vietnam, Armenia, China, Bangladesh), Europe (Turkey, Serbia, Montenegro) and Brazil.
A decision was made to issue 121 certificates of compliance of medicines manufacturing conditions with good manufacturing practice requirements.
Thanks to the coordinated work of the State Service of Ukraine on Medicines and Drugs Control and the state-owned enterprises Ukrainian Pharmaceutical Institute of Quality and Central Laboratory for Analysis of the Quality of Medicines and Medical Products, as well as management decisions to optimize the logistics of inspector travel under martial law (in particular, due to the lack of direct flights), became possible to significantly reduce the time required to process applications and conduct inspections compared to previous years.
Currently, the application review period is approximately two months, with a maximum acceptable period of one year, as stipulated by the orders of Ministry of Health.
The processed indicators demonstrate the systematic and effective work of the State Service of Ukraine on Medicines and Drugs Control in the field of ensuring the quality of medicines.
At the same time, we would like to inform that the access to the GMP compliance confirmation dashboard is now available. The link to it can be found on the main page of the State Service of Ukraine on Medicines and Drugs Control website.
The dashboard functionality allows to:
track the status of applications for compliance with GMP requirements;
promptly receive information about decisions made.
The service contains data on the status of applications registered since 5 December 2024. All business entities whose applications were registered after this date received a login and password to access the system at the email address specified in the application.
Our recommendations for business entities:
- actively use the dashboard functionality;
- prepare in advance the documents required for GMP compliance confirmation procedure in accordance with the requirements of the Procedure approved by Order of the Ministry of Health of Ukraine No. 1130 dated 27 December 2012;
provide feedback regarding the work of the State Service of Ukraine on Medicines and Drugs Control.