Ukrainian Medical Agency: Expectations of the Clinical Trials Industry from the New State Control Body
On the way to establishing a new unified state control body for medicines in Ukraine, or, as it is called, the Ukrainian Medical Agency (UMA), our government, with the support of international experts and the Ukrainian professional community, has to fulfill a number of tasks.
Thus, on November 30, Executive Director of the EBA Clinical Trials Subcommittee Iryna Magdik took part in the international forum “PharmExpert 2023: State Control Body in the Pharmaceutical Industry – the Beginning of a Long Way”, which included a discussion panel on the impact of the new body on the clinical trials industry in Ukraine.
Competent reform of the national legislation in the field of clinical trials on Ukraine’s path to the EU can provide ample opportunities for the development of global and local clinical trials of drugs, Ms. Iryna emphasized.
The mission of the EU’s main regulator, the EMA, is to promote scientific excellence in the evaluation and surveillance of medicinal products for the benefit of public health and animal health in the EU. “If we take the EMA as an example, we also have to create conditions in our new regulatory body that will meet the requirements and mission set by the EMA, and Ukraine, as a future EU country, should already be guided by these values,” I. Magdik said.
Speaking about the main tasks in the field of clinical trials that Ukraine faces when establishing and launching the state control body, the expert highlighted the following:
- The strategic task is to restore and increase the competitiveness of Ukraine to attract and conduct international clinical trials of innovative drugs with the launch of the new regulatory body and the Law of Ukraine “On Medicines”;
- To create better conditions in Ukraine than in the EU countries for approval, launching and conducting clinical trials of innovative drugs. Develop and implement programs to support clinical trials of all phases (1-3), including early phases;
- Implement the best practices of the EMA and EU countries for Ukraine’s participation in the development of innovative medicines;
- To preserve, improve and increase the expert potential of Ukraine to increase the competitiveness of the new regulatory body among the EU countries. It is important to do this now in the context of Ukraine’s accession to the EU, which will involve the implementation of Regulation 536/2014 and the centralized clinical trial approval procedure.
- Introduce modern technical capabilities into the work of the new regulatory body, minimize bureaucracy to enhance efficiency and speed up the process – full digitalization without paperwork (submission, communication, provision of a decision on conducting trials, visualization of the procedure stages, etc;)
- To enable the Ministry of Health to introduce the latest technologies into the practice of conducting clinical trials through by-laws.
What are the expectations of the clinical trials industry from the new state control body?
When establishing the body, the continuity of expertise should be preserved, i.e., the training of specialists; full digitalization of all processes; setting adequate tariffs – the cost of expertise based on fair market value, comparable to the cost in competing countries; clarity and comprehensibility of requirements.
During the transitional period, there should be clear communication with applicants/sponsors on the plans for the establishment and launch of the body, deadlines, and changes in processes. Training seminars should be organized for applicants on the transition and work in the new environment, as well as a short transition period, continuity of examination and approval.
During the functioning of the new body, the deadlines for approval of clinical trials / substantial amendments must be strictly observed. Ensure quality communication – bilateral dialog and the creation and functioning of a scientific and advisory department for planning and developing trials.
We need not only to restore the clinical trials industry, we need to build the basis for it to gain a significant competitive advantage. The most important aspect is patient access to advanced innovative therapies. Clinical trials make it possible to obtain such innovative examination and treatment. In addition, the clinical trials industry is very important for the Ukrainian economy and contributes to investment.