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Ukrainian Medical Agency - The Ministry of Health presented the concept and the way to create an independent regulatory body in the pharmaceutical industry

1 December 2023
24

The Ukrainian Medical Agency is a new independent state body responsible for registration and control of the market of medicines, medical devices, cosmetics and dietary supplements. Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, told the pharmaceutical industry representatives about the main parameters, stages, and timelines for the creation of the Ukrainian Medical Agency.

“The new regulatory body will create the same transparent procedures for both national and foreign pharmaceutical manufacturers and ensure zero tolerance for corruption,” emphasized Maryna Slobodnichenko.

The Ukrainian Medical Agency will be:

Strong. The new regulatory body will completely replace the State Service of Ukraine on Medicines and Drugs Control. In this area, it will also take over some functions of the Ministry of Health and the State Expert Center (SEC). In particular, the state registration of medicines and technical regulation of medical devices and cosmetics will be transferred from the Ministry of Health to the new agency. The Ministry will only have the function of policy-making in this area. From the SEC, the new agency will receive the authority to examine the registration of medicines, materials of clinical trials of medicines and pharmacovigilance, and will retain the function of evaluating medical technologies.

Independent. The Ukrainian Medical Agency will have a special status, independently adopt regulations and implement state policy in the pharmaceutical sector.

Transparent. The Agency will be evaluated annually by an external control commission. The Commission will consist of three people from the Verkhovna Rada of Ukraine, the Cabinet of Ministers of Ukraine and the Ministry of Health, who will be appointed for two years. In addition, the agency will establish a public control council with representatives of patient organizations, the pharmaceutical industry, and healthcare professionals. All nine members of the council will be selected through a competition and appointed by the Cabinet of Ministers.

Financially viable. The Agency will be funded from various sources: the state budget, grants, international technical assistance, and payments from pharmaceutical market participants. The latter include, in particular, the fee for state registration of a medicinal product, services for the examination of registration dossier materials, scientific consulting services, services for the use of an electronic cabinet, etc. The agency should gradually become self-sufficient. The amount of all fees and charges will be set only after consultation with market participants.

European-oriented. The new regulatory authority will operate under EU principles. To achieve this, Ukraine is currently implementing 53 directives and regulations, and Ukrainian experts are joining the work of the European Commission’s working groups and will be trained in the EU.

To launch the new regulatory authority, the Law No. 3345-IX of 23.08.2023 “On Medicinal Products” must be enacted. It is currently expected that this law will come into force 30 months after the end of martial law.

Instead, the Ministry of Health proposes to amend this Law so that it comes into force on 1 January 2025. This will launch the agency’s work. After that, a year of transition period will begin, during which functions will be transferred to the new body and procedures will be adjusted. 

It is expected that after the end of this transitional period, on 1 January 2026, the Ukrainian Medical Agency will be able to start its full-fledged work.