Determination of the investment project cost in developing a new generic medicine based on the content approach

Abstract

Aim. To determine the approximate cost of an investment project in developing a new medicine based on the generic type in the form of tablets taking into account the content approach in the common technical document (CTD) format of the registration dossier. Materials and methods. As materials the reports on research work in developing drugs, scientific publications, the own research and monitoring results of the pharmaceutical market of pharmaceutical company “Farmstandart” were used. The methods of generalization, systematization of the theoretical and practical material, marketing analysis, comparative and economic methods were applied. Results. The analysis and generalization of materials in determining the cost of development of new drugs has been conducted. On the example of the generic type medicine in the form of tablets in accordance with the requirements of the normative documents to the formation of the registration dossier in the CTD format the cost of the drug development and the necessary investments for each of five modules has been processed. Conclusions. The importance and necessity of determining the cost of developing a new drug as a complex product project have been substantiated. On the example of the generic type medicine in the form of tablets taking into account the requirements of normative documents the definition of the cost of development by 5 modules of the registration dossier has been worked out.