Strategy for introducing generic drugs into circulation in the context of the transition to the requirements of the Eurasian Economic Union

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.