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The company's mission «Market Access Solutions»

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.

 

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Clinical trials of implantable medicinal products may become mandatory

The Ministry of Health intends to oblige manufacturers of medical devices (MIs) to conduct clinical trials (CI) in two medical organizations - before registration and when making changes in the regulatory authority. The novelty will affect MI of various categories - from stents and tomographs to adhesive plasters. Industry participants do not agree with the agency's proposals - they are afraid of delay in entering the market of products and additional costs for testing.

Amendments are made to the Federal Law "On the circulation of medicines" in accordance with the standards of the Unified Energy System of Ukraine

The Ministry of Health of Russia has published a draft Federal Law on Amendments to the Federal Law "On the circulation of medicinal products" with regard to the information contained in the State Register of medicines on preparations that have passed state registration with a view to further forming a common information resource of the member states of the Eurasian Economic Union.

The State Duma Committee for Health Protection did not support the bill on changing the period for the cancellation of state registration of medicines

The State Duma Committee on Health Protection did not support the draft law "On Amendments to the Federal Law" On the circulation of medicines "at a meeting on June 14. The document specifies the time period for the cancellation of state registration of a medicinal product and its exclusion from the state register of medicinal products in the event of the absence of a drug in circulation in the Russian Federation.

The rules for carrying out DKI, CI, bioequivalence studies of veterinary drugs

On June 6, the Ministry of Agriculture of the Russian Federation published Order No.0101 of 06.03.2018 "On approval of rules for preclinical research of a medicinal product for veterinary use, clinical study of a medicinal preparation for veterinary use, bioequivalence of a medicinal preparation for veterinary use". The document was registered with the Ministry of Justice on 05/06/2018, No. 51296.

Subsidizing purchases of orphan drugs in the regions can earn from January 1, 2019

The Ministry of Health of the Russian Federation has developed and submitted for public discussion on the website regulation.gov.ru the draft resolution of the Government of the Russian Federation "On the Approval of the Rules for Granting and Distributing Subsidies from the Federal Budget to the Budgets of the Subjects of the Russian Federation for Arranging for Persons Affected by Life- leading to a reduction in the life expectancy of citizens or their disability, drugs and specialized products of therapeutic nutrition ".