Introduction. Effective management of the product portfolio is crucial for the development of the pharmaceutical business, oriented both to the global and national markets. The key competence of portfolio management is the procedure of new products inclusion. The purpose of the study was to review the main types of expertise of a drug candidate for inclusion into the product portfolio, considering the specifics of the current Russian operating conditions, as well as to identify responsible participants and to develop a business process model that can be implemented in practice. Materials and methods. The study, based on the generalization of practical experience, used a comprehensive approach to the analysis of the stages and types of expertise that are necessary for planning of the inclusion of new drugs into the portfolio. Results and discussion. The specifics of portfolio management of Russian manufacturing companies are defined, consisting in the predominance of generic drugs, high dependence on the state policy and limited access to technological innovations. A model of the business process for evaluating drug candidate is developed, including the stages of forming the product target profile, analyzing market, medical and patent information, assessing the possibility of pharmaceutical development, planning key marketing indicators, and the final financial assessment. The composition of the multidisciplinary team is described and key indicators for assessing the investment attractiveness of new products are proposed. Conclusions. Inclusion of new products into the product portfolio of Russian pharmaceutical companies requires an integrated approach based on a comprehensive assessment of the drug candidate and strategic market opportunities. The creation of specialized units for portfolio analysis and development, as well as the implementation of the developed business process model will allow pharmaceutical companies to adapt to market challenges, increase competitiveness and ensure sustainable development.