Problems of Social Hygiene, Public Health and History of MedicineProblems of Social Hygiene, Public Health and History of Medicine0869-866X2412-2106Joint-Stock Company Chicot141810.32687/0869-866X-2025-33-1-112-118НеопределенThe problem of quality of medications at Russian market (1992–2004). Report II. The control of new and serially produced medicationsIgnatievV Gig_vas@mail.ruZatravkinS Nzatravkine@mail.ruVishlenkovaE Aevishlenkova@mail.ruN. A. Semashko National Research Institute of Public Health, 105064, Moscow, RussiaThe Ludwig-Maximilian University of Munich, 80539 Munich, Germany1604202533117042025Copyright © 2025,2025<p>The archives of the Ministry of Health Care of Russia, journal publications, interviews and memoirs testify that issue of medications quality was key issue in life of Russian Pharma in 19922004. The support of medication safety considered not only as part of social policy, but also as rules that could be used to reformat the wild bazaar into controlled market. The media disputes, departmental justifications, political bills and memoirs give idea about price of the issue (heat of emotions, ambitions, financial losses). Besides, depending on who would determine quality (and thus to evaluate all players of Pharma market) depended placement of center of power in market. The authors of the study present in series of reports results of historical reconstruction of building materials, architects and technologies of construction of Russian control and authorization-based system and market rules. This report deals with practices of expertise of new and serially produced medications.</p>history of medicinehistory of pharmacycontrol and authorization-based systemmedication qualityистория медициныистория фармацииконтрольно-разрешительная системакачество лекарств1.Kovalyova E. L., Balandina I. A., Mitkina L. I. International and domestic experience in the field of regulation of admission of pharmaceutical substances and excipients to the production of medicines. Vedomosti NCJeSMP. 2011;(1):19–24 (in Russian).2.Petrenko A. N., Vasiliev P. A., Martsevich S. Yu., Kutishenko N. P., Zvonareva O. I. Registration of drugs in the Soviet control and licensing system on the example of cardiological drug Trinitrolong. Racional'naja farmakoterapija v kardiologii. 2021;17(1):133–9 (in Russian).3.Sigidin Ya. A., Pokryshkin V. I. A new non-steroidal anti-inflammatory drug pirprofen (Rengazyl) in the therapy of rheumatoid arthritis and osteoarthritis. Terapevticheskij arhiv. 1987;(4):73–6 (in Russian).4.Gildeeva G. N. Development of the system of normative-legal regulation of expertise and registration of medicines. Remedium. 2007;(3):46–51 (in Russian).5.Ethical expertise of biomedical research. Practical recommendations [Jeticheskaja jekspertiza biomedicinskih issledovanij. Prakticheskie rekomendacii]. Under the general editorship of Y. B. Belousov. Мoscow: 2005 (in Russian).6.Business Guide to the Pharmaceutical Market of Russia [Biznes-putevoditel' po farmacevticheskomu rynku Rossii]. Edited by A. Yudanov et al. Moscow: Classic-Consulting; 1998 (in Russian).7.Belikov V. G. General pharmaceutical chemistry: Textbook for pharmaceutical institutes and faculties of medical institutes [Obshhaja farmacevticheskaja himija: Uchebnik dlja farmacevticheskih institutov i fakul'tetov med. institutov]. Moscow; 1993 (in Russian).8.Shirokova I. On guarding the interests of Russian patients. Remedium. 2003;(11):70–3 (in Russian).9.Shirokova I. Pharmaceutical market of Russia and the Moscow region: time to summarise the results. Remedium. 2004;(3):80–2 (in Russian).