Prostamol uno 30s 2019 04 MN 0416
According to the order of Rosstat No. Published by GMPnews. Net s. Vydavatelství GMPnews. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by Prostamol Uno in Volgograd means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of GMPnews. The opinions and views expressed by the authors in this journal are not necessarily those of the Editor or Prostamol Uno in Volgograd and, while every care has been taken in preparation of the journal, the Editor and Publisher are not responsible for such opinions and views, or for any inaccuracies in the articles.
Dear reader, First of all, allow us to thank Prostamol Uno in Volgograd for Your interest in the magazine You are now holding in Your hands. In the last few years, the situation on these markets has changed fundamentally. That is why this is the main topic of our publication. In addition, we are going to bring to Your attention Prostamol Uno in Volgograd possibilities of business cooperation in development and manufacturing of quality, effective, and safe medicinal products with manufacturing plants in CIS and EAEU markets.
Have a look at the statistics and analytics in the articles you are about to read. This is one of the reasons why contract manufacturing was chosen as the main theme of this issue. Modernization of current manufacturing facilities, construction of new production plants, implementation of stateof-the-art pharmaceutical technologies, servicing, industrial training, and staff development are among the most important subjects discussed in this publication.
Guidance and help with materials from this issue was provided by our partners' specialists and experts. Let me introduce our partners:. FAVEA Group - a leading European pharmaceutical engineering company, having successfully implemented dozens of major projects, mainly in Russia. They are Prostamol Uno in Volgograd specialized state institution that performs inspections of pharmaceutical manufacturers for compliance with GMP in Russia and abroad. We work closely with our main partners to promote the services and expertise that they offer.
Common Market of Medicines: Processes and Approaches. Pharmacovigilance in Russia in Questions and Answers. Stephan Rönninger, Andrei Meshkovki. Russian Pharmaceutical Industry: Cooperation in Competition Girish Malhotra. Nikolay Bespalov. Selected Indicators of the Russian Pharmaceutical Market Development in and in the 1st and 2nd Quarters of Alexander Toporkov, Irina Novikova.
This is a largescale integration instrument for various participants operating in the Prostamol Uno in Volgograd of medicinal products and medical equipment.
The Russian Ministry of Industry and Trade acts as the main Customer of the Program and coordinates the activities of all industries. The largest and globally recognized universities, scientific organizations, and Russian pharmaceutical companies are actively involved in the Program.
Its participants include entities with various forms of ownership. The effective collaboration between all market participants, including com. Currently, the share of Russian-made medicines from the list of vital and essential drugs stands at As compared to 96 billion rublesthe manufacturing of medicinal products increased almost threefold and, inamounted to Sincethe share of Russian-made medicines increased from The share of domestically manufactured drugs in total procurement under 7 Nosologies program increased from 4.
Over the past 5 years, the pharmaceutical industry attracted more than billion rubles of private investments made by foreign and Russian companies, while the funds allocated by the federal budget amounted to 35 billion rubles.
Forty four import-substituting medicinal products as of January 1, and. Another 20 medicines are scheduled for registration in There were 35 newly opened production sites.
There are more than companies operating in Russia. The Russian Ministry of Industry and Trade established a whole set of measures to support the development of pharmaceutical and medical industry.
There are subsidies for conducting the clinical trials, organizing the manufacturing of substances, developing improved analogs of innovative medicinal products; the mechanism provided by Special Investment Contract, preferences for industrial clusters, and preferential lending by the Industrial Development Fund. Inthe Ministry of Industry and Trade of Russia provided subsidies for implementing 6 projects to manufacture pharmaceutical substances, 34 projects to develop new medicines, and 10 projects to develop Prostamol Uno in Volgograd drugs for a total amount of almost million rubles.
Today, the Russian industry can satisfy needs of the country in highly effective medicinal products and high-quality medical equipment to Prostamol Uno in Volgograd national security in the area of healthcare.
The total investment budget planned for supporting the pharmaceutical industry under the State Program will amount to 7. Rozhdestvenskiy, could you explain to our foreign readers what the Eurasian Economic Union is in more detail?
The Union started functioning on January 1,which was the effective date of the Treaty. This territory is inhabited by The EAEU member states also rank second in the world in terms of railway mileage, and fifth in the world in terms of highway mileage.
Standardization Concept of harmonization of pharmacopoeias Pharmacopoeial Committee Interaction for identifying substandard and counterfeit medicinal products. The Union was formed to facilitate comprehensive modernization and cooperation, make the national economies more competitive and foster the environment for sustainable development with a view to improving the quality of life of the population in the member states.
The EAEU ensures free Prostamol Uno in Volgograd of goods, services, capital, Prostamol Uno in Volgograd labor, as well as the pursuit of Prostamol Uno in Volgograd, harmonized, or common policy in different sectors of economy by all EAEU member states. The most important decisions within the EAEU are taken by the supreme body of the EAEU, the Supreme Eurasian Economic Council, which includes the presidents of the member states, and by the Prostamol Uno in Volgograd Intergovernmental Council, which consists of the heads of governments.
In accordance with the principle of annual rotation, inthe Union bodies are chaired by Kyrgyztan, with the President of Prostamol Uno in Volgograd being Chairman of the Supreme Eurasian Economic Council accordingly. Since we are a pharmaceutical journal, we, and Prostamol Uno in Volgograd readers would like to know more about the common market of medicinal products and medical devices within the EAEU, which started its operation on May 6, Which documents have already been adopted and which documents are still under development?
Indeed, Prostamol Uno in Volgograd year, on May 6, the national pharmaceutical markets of the five member states of the Eurasian Economic Union merged and started functioning in Prostamol Uno in Volgograd format of a Common Economic Space CES.
Manufacturers from the EAEU member states may file applications for registration and release into circulation of medicinal products, following Prostamol Uno in Volgograd procedures for all EAEU member states. The Eurasian Economic Commission in cooperation with the leading experts from the five member states of the Union prepared all documents necessary for the effective operation of the common market taking into account global experience.
These documents form. The figure below shows the main types of these documents, grouped in four blocks. Overall, the ICH International Conference on Harmonization approaches to the electronic format of the registration dossier were used, which allow manufacturers to prepare a registration dossier in electronic format, or the so-called eCTD. Of course, there will be a transitional period to ensure a smooth transition from national to common regulation.
This will prevent disruptions in the function. All medicinal products registered under the national procedure before January 1,will continue to be marketed until December 31, However, in the case of registration under the national procedure, the medicinal product concerned will be marketed only within the relevant state, and its registration certificate even if granted for an indefinite period of time will cease to be effective from 1 January After 1 Januaryan applicant will be able to register its new medicinal products only under the common procedures.
Since the minimal duration of DP is days, this is exactly the period of time that a particular medicinal product will need to reach the market.
Since the minimal MRP. All medicinal products registered under the national procedures before 1 Januaryand also during the transi. If we Prostamol Uno in Volgograd look at this economic community from the point of view of a western pharmaceutical company willing to localize its production in one of the Union member states, what regulations and laws should Prostamol Uno in Volgograd be guided by in the first place? When localizing production in the territory of a EAEU member state, first of all, it is necessary to be guided by the legislation of that Prostamol Uno in Volgograd and by the Prostamol Uno in Volgograd of the Union GMP guidelines.
Is there any single regulatory authority in the Union which is responsible for controlling pharmaceutical manufacture, or is everything done locally, but according to the EAEU rules? Control and supervision within the Union are carried out by the national competent authorities in accordance. Since the territory covered by these five states is quite large, any manufacturer, whether a western or a local one, is concerned about the distribution of their pharmaceutical products.
Is transport and overall logistics structure ready for a common market? Until April 26,there is a transitional extension period for the application of the Union's GDP guidelines, which is connected with the need to prepare the transport and logistics structures. A key role in the process of standardization of medicinal products and Prostamol Uno in Volgograd is played by Pharmacopoeia. Will it be based on one of the pharmacopoeias of the EAEU member states, or will a whole new collection of monographs be created?
It includes experts in the fields of pharmacy, medicinal chemistry, and analytical chemistry from. The Pharmacopoeial Committee has an equally proportional number of representatives of every member state. Prostamol Uno in Volgograd main task of the experts of the Pharmacopoeial Committee is to develop the Union Pharmacopoeia as quickly as possible. It will establish the required quality standard for pharmaceutical manufacturers and will provide consumers with safeguards to guarantee that the medicinal products launched in the entire market of the EAEU meet a Prostamol Uno in Volgograd standard.
Now the Pharmacopoeia Committee is working intensively on the first volume of the Union Pharmacopoeia. Its development is carried out in accordance with the concept of harmonization of pharmacopoeias of the EAEU member states on the basis of their national pharmacopoeias and basic pharmacopoeias EP, BP, and USP. In parallel, since Augustthe EAEU Pharmacopoeia has been included as one of the regional quality standards in the WHO list of world pharmacopoeias and pharmacopoeial bodies. All documents of the Commission that were developed and entered into force on Prostamol Uno in Volgograd 6, are directly applicable documents.
This means that they do not require adoption of any national regulations governing their use in each of the Member States. Thus, from May 6 this year, all stages of development, production, study of medicines in preclinical and clinical studies should be carried out in accordance with the requirements of the relevant decisions of the Commission. Currently, there is Prostamol Uno in Volgograd transitional period in respect of the registration of medicines till the end ofduring which each producer may choose to register a medicine under national law.
While the competent bodies of the Member States may not refuse manufacturers of medicines in receiving a product specification file for registration under the rules of the Union. Talking about the administrative procedures Prostamol Uno in Volgograd the registration authorities, representatives of the Commission noted that, till December 31,all medicines registered in the Member States under national procedures, should bring their product specification files in compliance with the rules of the Union.
This can cause some difficulties for those manufacturers in the Russian Federation that registered synthetic medicines for oral use without performing any clinical or bioequivalent studies, exclusively on the basis of submission of literature reviews so-called "well-established medicines". The Union registration rules for this group of medicines provide for dissolution kinetics test and a special procedure for consideration, if the medicine has grade I or III of the biopharmaceutical systems or bioequivalence studies, if the product has grade II or IV under.
It will include three representatives from each Member State. Specialized groups will begin their work under the Committee. The tasks of the Committee will include resolution of differences in circulation of medicines, preparation of recommendations within the period of up Prostamol Uno in Volgograd 60 days, as well as elaboration of proposals on harmonization and unification of the laws of the EAEU Member States.
The authorities for registration and monitoring of circulation of medicines remain at the level of the Union Member States.