Регистрация лекарственных средств в советской контрольно-разрешительной системе на примере кардиологического лекарственного препарата Тринитролонг
Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients
In clinical trials comparing experimental and control treatment the effect of treatment often depends on the range of patient’s characteristics (biomarkers) such as clinical, anthropological, genetic, psychological, social characteristics and others. Personalized medicine aims at finding such dependencies to tailor treatment strategies to a patient. This paper presents an overview of the approaches to data analysis of clinical trials intended for identification of influential biomarkers and subgroups of patients, where experimental and control treatment differ significantly in efficiency.