The year 2019 in the work of the State Expert Center of the Ministry of Health brought a number of innovations that improved communication with applicants and increased the transparency of the Center's work.
At first, the opening of the “Service Center” caused many complaints. But thanks to the professional work of the operators, in less than a month the introduction of this model met all expectations. Since then, applicants can submit materials at the moment they are ready, without waiting several weeks for an appointment with an expert. For the Center's staff, the time available for conducting expert evaluation has increased significantly.
The introduction of an electronic registration form for amendments during the validity of registration certificates has reduced the time needed to enter them into the electronic database. Next in line is the introduction of such a form for registration, a test version of which already exists, and subsequently for re-registration.
Improvement of the “Visualization” system has enabled applicants to respond promptly to experts' comments.
For the first time since 2012 (since the entry into force of the amendments to Article 3212 of the Criminal Code of Ukraine), the number of approved international multicenter clinical trials (CTs) of medicinal products (MPs) in Ukraine has exceeded 200 CTs and reached 210 CTs of MPs. This was the result of the Center's active measures to improve the image of the domestic sector of clinical trials of medicinal products and increase its investment attractiveness.
Also, in order to improve the quality of the procedure for expert evaluation of clinical trial materials for medicinal products, optimize its timelines and further harmonize the regulatory legal acts of Ukraine with EU legislation, the Center has sent to the MoH a draft of amendments and additions to the Procedure for Conducting Clinical Trials of Medicinal Products (order 690). These changes were prepared based on the results of the work of a working group that included representatives of domestic and foreign manufacturers, the European Business Association, and researchers.
Another innovation was the modernization of the Automated Pharmacovigilance Information System (AISF). Starting in 2020, the system will allow applicants to create a personal electronic “Applicant's Cabinet” in the AISF, through which they will be able to upload xml files in the E2BR2 and E2BR3 formats on their own and to receive, at any time, information on adverse events following immunization and on adverse reactions to medicinal products, vaccines, and tuberculin that they supply to the Ukrainian market.
Implementation of the audit of applicants' pharmacovigilance systems (hereinafter – PVSA) has begun, and pilot activities regarding PVSA are currently under way.
Finally, 2019 became a landmark year in the institutional development of the health technology assessment (HTA) area. Following an open competition, the staff of experts of the HTA Department was formed. Draft regulatory legal acts are being actively developed, which, after approval by the MoH, will form the basis of the new system of managerial decision-making. Going forward, we count on the support and cooperation of the stakeholders in this process – the SAFEMed project, higher education institutions, manufacturers, and applicants for medicinal products.
Ambitious plans to implement eSubmission during 2020 confirm the commitment to maximum adoption of European norms and principles, convergence with the European Union, and close cooperation with the European Medicines Agency, as well as other stringent regulatory agencies in the field of medicinal product regulation. In the near future, we expect approval from the MoH for the representation of the Center's experts in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
We sincerely rejoice in the successes of our partners – the National Health Service of Ukraine and the State Enterprise “Medical Procurement of Ukraine”, whose role in the transformation of the healthcare system was decisive in the year that is ending.
We thank our steadfast partners: the Ministry of Health of Ukraine, the State Service of Ukraine on Medicines and Drugs Control, the Public Health Center, the NHSU, professional associations and international partners for their assistance in fulfilling the tasks assigned to the Center. Our achievements are noticeable, and our plans are even more ambitious.
Happy upcoming New Year!
