On the sixth day I of the All-Russian Pharmaceutical Run in Yaroslavl discussed the acute issues of launching new drugs on the market.
The moderator of the round table is “Registration and launch of new drugs on the market. The social aspect and regulatory issues ”was made by Victor Dmitriev , Director General of the Association of Russian Pharmaceutical Manufacturers, who spoke about the Yaroslavl pharmaceutical cluster and its activities:“ The cluster is developing successfully. A technology transfer center has been built here. The Filin Innovative Pharmaceutical Camp is held annually. It’s correct and great that Farm Run visited us. ”
Igor Kahramanyan, First Deputy Chairman of the Committee of the Council of the Federation on Social Policy, highlighted the challenges facing the state in the field of the withdrawal of new drugs, spoke about the successes of the Yaroslavl pharmaceutical cluster and the prospects for the development of the pharmaceutical industry. The expert also noted that much remained to be done to correct the biased attitude towards generic drugs. “The launch of new drugs on the market is important for the accelerated, innovative development of healthcare. It is important to note the role of the regulatory framework. It combines the optimization of the timing of registration procedures, and balance. We believe that our regulatory system is one of the most advanced, and this is recognized by the international community, ”- & nbsp; Igor Kahramanyan shared.
Filipp Romanov , Director of the Department for State Regulation of Drug Circulation of the Ministry of Health of the Russian Federation, spoke about bills aimed at optimizing the procedure for registering drugs, and also answered questions from the moderator about regulatory documents in the field of pricing and putting into circulation. The speaker also spoke about the possibility of introducing in our country medicines of the ECE countries that did not accept the Russian labeling system: “We are ready to arrange a meeting with us. Today it is assumed that the products that will be in circulation with us should be labeled. ”
Boris Romanov , Deputy Director General for Science, FSBI “NTsESMP” of the Ministry of Health of Russia, spoke about the terms of the registration procedure, successes for 2018, innovations in this area and the transition to ECE rules. The expert noted a reduction in negative opinions over the past few years from more than 50% to 4%, explained the features of the adoption of a registration certificate in other countries when passing it according to ECE rules. The report noted the role of the non-regulatory side of the process: “The registration procedure is not only the activities of regulatory authorities, but also applicants. They must respond to the request within 90 days. Only 10% of applicants answer questions within 10 days. ”
Head of the Department of Clinical Pharmacology with an EITI course at Yaroslavl State Medical University Alexander Khokhlov spoke about a project that aims to address the stated issues, such as financing science, digitalization, human resources, rational use of drugs and studying the need for drugs: ” The life expectancy of patients is the most important thing that we want to achieve. This issue is the focus of all health related activities. We were instructed to create an Interdepartmental Council for the scientific justification and support of the national drug policy of Russia. ” The expert noted that the proposed model can find implementation in pilot projects.
Ilya Wesker , director of government relations, spoke about international pharmaceutical trends, new life extension technologies, registration and financing difficulties, and shared the company’s strategy and possible solutions to the tasks: “The goal of our strategy is to solve two questions. This is the shortest possible time for the registration of drugs and ensuring the affordability of drugs for the end user. ” The expert also proposed a more dynamic development of the list of orphan diseases of the Ministry of Health, an “audit”, and then, in his opinion, companies would be more willing to work on this problem, which would improve the situation with drug supplies.
The discussion was closed by Dmitry Chagin , Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU. The speaker raised the topic of price reduction and presented a vision of how to implement it. The expert also spoke about the mandatory conditions for the emergence of innovative drugs: “There will be no innovative drugs if there are no innovative companies. There will be no innovative companies if there are no proper innovative climate conditions in certain regions, there will be no clusters. And clusters are impossible without a scientific and educational foundation. ”
An excursion to the pharmaceutical production of Takeda Pharmaceuticals completed the business program in Yaroslavl.