Pharmacoeconomics: theory and practice
№2, 2024, Vol.12

Introduction. The harmonization of regulatory requirements in the field of development and circulation of medicines at the stage of transition from national to supranational regulation predetermined the multitasking and multidirectionality of registration processes for the development organization. An analysis of the regulation of registration processes (both national rules and the rules of the Eurasian Economic Union), recommendations on drug registration from the world’s leading Agencies (EMA, FDA), as well as the experience of pharmaceutical development (PD) and registration of drugs allowed us to establish the potential need to organize of registration procedures and searching for organizational and methodological solutions at the organizational level that affect the registration process of the reproduced drug. Aim. To development of a strategy for putting into circulation a reproduced drug for the implementation of organizational and methodological decisions on the registration and putting of a drug into circulation in the territory of the Eurasian Economic Union (EAEU). Materials and methods. The regulatory legal acts of the Russian Federation, the EAEU, and foreign regulatory authorities regulating the rules for registration and examination of drugs for medical use have been studied; recommendations of interintegration associations (ICH, FDA); documents of the registration dossier for the drug of the manufacturing organization (customer), reports on the DF of the reproduced drug. Results and discussion. The registration strategy (marketing/putting into circulation) is based on the strategic objectives of the customer organization, the requirements of regulatory legal acts of the Russian Federation, documents of the Eurasian Economic Union (EAEU), principles and approaches in the field of drug circulation in foreign countries, and eligibility criteria for the selected LP. Successful registration of a drug is based on organizational and methodological decisions in accordance with the general concept of putting into circulation a reproduced drug at the organizational level. In the framework of the ongoing research at the organizational level, we understand the “strategy for introducing drugs into circulation” as a scientifically based structuring of processes based on phasing and priority, taking into account regulatory requirements, recommendations of interintegration associations (ICH, FDA), development trends of the pharmaceutical market and opportunities for financial development. Developed strategy introduction of reproduced medicines into circulation is aimed at the effective management of registration procedures at the organizational level. The strategy ensures compliance with the regulatory requirements of the EAEU and other interintegration associations, and customer requests/expectations. Following the developed strategy reduces the risks of delays in introducing high-quality, effective and safe domestically produced drugs to the market. Conclusions. The developed strategy for introducing generic drugs into circulation, which includes scientifically based stages and criteria, is aimed at the effective management of registration procedures at the organizational level. The strategy ensures compliance with the regulatory requirements of the Union and other interintegration associations, and customer requests/expectations. Following the developed strategy reduces the risks of delays in introducing high-quality, effective and safe domestically produced drugs to the market.

TARGET. Generalisation and comparative analysis of the personal scientific contribution of Russian scientists to the development of scientific, practical and educational knowledge on pharmaceutical provision of the population of the Russian Federation, expressed in the frequency of mentioning their names in the abstracts of candidate and doctoral dissertations on organizational aspects of pharmaceutical science and practice. MATERIALS AND METHODS. Preservation and multiplication of scientific knowledge is impossible without an objective assessment of the contribution of predecessor scientists in the development of a particular field of science. This approach provides a full-fledged characteristic of a certain scientific direction, and also serves as a recognition of the merits of scientists who have put their talents and efforts to establish in the world community of domestic pharmacy, as an independent scientific and practical sphere of public life. For the first time, a study of the array of personalities of predecessor scientists by scientific generation, scientific status and gender was conducted. The general characteristics of the array of predecessor scientists’ surnames were calculated according to five indicators. The results indicate an increased attention of dissertators to the works of their predecessors. A comparative analysis of the frequency of mentioning, ranks and places in the ranking of predecessor scientists was carried out, which made it possible to form lists of Top-20 surnames of scientists for three time periods that actively shaped scientific knowledge on drug supply. Generalisation of data for all time periods allowed us to establish a list of Top-10 scientists who have made and continue to make the greatest contribution to the scientific support of the improvement of the Russian drug supply system. CONCLUSION. The importance of preserving and multiplying the continuity of domestic pharmaceutical knowledge for the next generations of research scientists is demonstrated. It was found that scientists from the Top-10 list belong to different scientific generations, but at the same time, there is a constant scientific interest shown by young researchers in the works of their predecessors.

Goals and objectives: to identify niches for studying the Russian antitumor drug “AntionkoRAN-M” (INN Stimothimagen copolymerplasmid) within the framework of phase 2 and 3 clinical studies and further use in medical practice. Materials and methods: during the study, a review of the clinical recommendations of the Ministry of Health of the Russian Federation and NCCN for the management of a number of oncological diseases in the treatment of which the drug “AntionkoRAN-M” could potentially be used was carried out. Further analysis identified groups of patients that differed from each other in the number of available treatment options, as well as the level of strength of recommendations and the reliability of evidence for these options. Further, the description of the selected groups of patients was validated with oncologists from leading federal centers and the characteristics of patients most in dire need of new effective treatment options were noted. Then, according to statistics and epidemiology, the population size in each of the selected groups was predicted by the expected time of the drug entering the market. Results: it was found that the optimal niches for studying the drug “Antionko- RAN-M” within the framework of a phase 2 clinical trial will be the inoperable stages of the following malignant neoplasms: soft tissue sarcoma for use in the 3+ line and, partially, in the 2nd line; melanoma in combination with immunotherapy (IT) in 2+ lines in patients with unmutated BRAF and KIT status; head and neck tumors (HNT) as neoadjuvant therapy for platinum intolerance; cervical cancer (CC) in relapse at a locally advanced stage. The predicted number of patients in these groups who annually require innovative therapy may total more than 1,300 for orphan diseases: sarcoma and melanoma. There may be more than 5,000 patients in the general hospital and cervical cancer - potential candidates for therapy with the drug “AntionkoRAN-M”.