Our mission - is to facilitate the transition of the Russian pharmaceutical market to develop into mature, be a guide on the course of development of the potential of all the pharmaceutical market participants, thereby improving the quality of life for the end user and society in general. Despite the relatively high susceptibility to Russia's external economic and financial risks, imbalances in the domestic policy and great social disparities, the pharmaceutical market in Russia has had a stable positive growth for the last few years.
According to the company DSM Group, the volume of the commercial drug market in December 2017 amounted to 69.3 billion rubles, which is 7.5% more than in November 2017 and 2.4% more than in December 2016.
Separate provisions of the Federal Law No. 505-FZ dated December 31, 2017, which amends the Law No. 223-FZ "On Procurement of Goods, Works, and Services by Certain Types of Legal Entities" will come into force on July 1, 2018. They prohibit PMU, MUP and AO with a 100% stake in the state to make purchases by trade names.
The Ministry of Health of the Russian Federation has prepared a Draft Resolution which amends the Regulation on the Federal Service for Supervision in the Field of Health in order to supplement the powers of the Roszdravnadzor with the following powers:
The term "essential drugs" has been actively in place since 1975 when the World Health Assembly adopted the concept of "essential drugs" and "national drug policy". In 1977, the World Health Organization (WHO) published for the first time the WHO Model List of Essential Medicines (WHO Model List), which was designed to help other countries develop their own national lists. In the Alma-Ata Declaration adopted in 1978, the provision of essential medicines is recognized as one of the elements of primary health care. Today, the concept of creating a list of essential medicines as drugs that meet the priority needs of the health system has gained universal acceptance.
From January 1, 2018, a resolution of the Government of the Russian Federation No. 1397 dated November 15, 2017 "On the Specifics of the Description of Medicinal Products for Medical Purposes, which are the Object of Procurement for the Provision of State and Municipal Needs", enters into force. In the opinion of the advisor to the Director of the Institute of Public Procurement Anna Ermakova (pictured), customers, suppliers and manufacturers of medicines need to ask clarification from the regulators in order to bring the practice of applying this ruling to a comprehensible and adequate format for medical purposes.
AstraZeneca plans to spend within three years within the SPIC the localization of the production of ten medicines, six of which have no analogues in the Russian Federation. As Irina Panarina, general director of AstraZeneca, Russia and Eurasia has informed, from the end of 2019 these preparations will begin to enter the commercial market.
The manual "Clinical Research Management" describes a methodology for the effective management of a project for finding, developing and marketing pharmaceuticals, starting with the search for promising chemical compounds, preclinical testing of candidate substances, clinical trials of candidate drugs, pharmacovigilance, data management, analysis of the data obtained, compilation of a final report on the study, obtaining a registration certificate, publication of the results Tats, to organizing post-marketing safety studies, conducting non-interventional and pharmaco-epidemiologic studies, as well as the quality assurance process of the audit, and authorized health authority inspections, creation of standard operating procedures, archiving research documents.