Against the background of restrictions on inspections during martial law in Ukraine, the number of falsified, low -quality and illegally imported drugs has grown up. One of the tasks of the new state control body (OGK) in the pharmaceutical industry, which will work on January 1, 2027, is an effective struggle against falsifications, writes to manufacturers and consumers to expect Farmoti European Healthy Minister of Health of Ukraine on European integration Marina Slobodnichenko.
" This is 2.7 times more than during the 2023rd, ”the Deputy Minister indicates.
According to her, now the control over the production and turnover of medical devices and medicines in Ukraine is kept on three whales: the Ministry of Health, the State Expert Center (HEC) and the Derzym. The Ministry makes a decision to register new drugs, allows them to experience and regulates the activities of the pharmaceutical sphere.
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At the same time, the GEC is responsible for the examination, checking the quality and safety of the drug during its state registration. In turn, the land service inspects production, issues licenses for production, import and sale and controls the quality of drugs. According to Slobodnichenko, because of this dispersion of authority, the process is complicated, the organs partially duplicate each other.
" He will be responsible for the full cycle of circulation of drugs - from production and imports to sales in pharmacies. OGK will also regulate medical products, cosmetics, drugs, precursors, blood and substances of human origin, ”she said.
The Deputy Minister writes that the main task of the new body is to ensure the safety of drugs in Ukraine: both domestic and foreign. He will fully be responsible for the quality control of drugs in the market and will act according to European standards. The processes of registration of lex editions, licensing and pharmacon supervision will also translate into digital format.
In addition, the appearance of OGK will increase Ukraine's chances of gaining access to databases and digital systems of the European Union, in particular to Eudravigilance. With the help of this reporting system and evaluating the side effects of drugs in Europe, the safety of these drugs is monitored. If OGK has access to this system, he will be able to monitor the safety of drugs in Ukraine according to EU standards. Moreover, this can be done before entering the EU.
Slobodnichenko indicated that Ukraine is a potential EU partner for the supply of critical drugs. Our country provides a full cycle of production of more than 30 critically important drugs from the approved EU list: clonidine, nimodipine, adenosine, clonazepam, rilusol, neostigmin, insulins of various durations and others. The deficiency of these drugs was in Europe during the Pandemia of Coronavirus.
" The EU regulatory policy will open access to international markets for Ukrainian drugs, which will make the supply chains in Europe stable, ”she said.
Another advantage of the appearance of OGK for Ukrainian manufacturers, the Deputy Minister’s approach to obtaining state status with strict regulatory policy (SRA) and the mutual recognition of GMP-certificates (good manufacturging, GMP) between Kiev and the Russians. Thanks to this, manufacturers have a green light on the markets of the EU countries.
Earlier, the Cabinet of Ministers decided to expand the state program " Starting from August 2025, medications will be available in the program that helps the treatment of anemia in pregnant women. In particular, we are talking about a double -glove -gland, which will be provided in the form of tablets, syrups and solutions, as well as folic acid in a tablet form.