The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

The issues of drugs expert evaluation were discussed by the participants of the RegLek-2018 conference

At the RegLek-2018 conference, the modern approaches to drugs expert evaluation, the issues of regulation, the peculiarities of registration file compilation as per the EAEU procedures, and the issues of drugs development within the good practices philosophy were discussed.

The EAEU member states face very important tasks on implementing the decisions made by the Eurasian Economic Commission (EEC) on national levels. The State Institute of Drugs and Good Practices together with the Minpromtorg of Russia have put forward an initiative on creating a working group on pharmaceutical inspections under the EEC to develop unified approaches to carrying out pharmaceutical inspections following the common EAEU rules. This was emphasized during the plenary session of the RegLek-2018 conference – «Modern approaches to drugs expert evaluation» – by the Deputy Head of the Russian GMP-Inspectorate, the Director of FSI «SID & GP» Mr. Vladislav Shestakov.

«During inspections of foreign drug manufacturers, inspectors find non-conformities related to violation of the registration file», said Mr. Vladislavl Shestakov. «Such observations comprise about 35% from the total amount of observations in 2017 and about 36% of the total amount in 2018. So, we can conclude that applicants do not give due consideration to registration documents and do not bring them to compliance. FSI «SID & GP» sent 8 letters to the Ministry of Industry and Trade of the Russian Federation with the notification about violations and suspension of distribution of drugs manufactured against GMP requirements.»

The situation can be rectified by means of a harmonized regulatory system with supranational instruments. Until 1 January, 2022, normative documentation shall be brought to compliance with general monographs. With that, in 2020, the common

Eurasian pharmacopeia is planned to be put into effect, which is actually a common standard for normative documents.

Besides, the section on the topic «Peculiarities of registration file compilation and submission according to the EAEU procedure: first experience» was dedicated to the issues of the scope of preclinical and clinical trials of drugs upon registration file compilation in the Common Technical Document format, the issues of the recommendation by the EAEU and expert bodies of the EAEU as a tool for providing common mandatory requirements for drugs circulation within the EAEU. The Head of EAEU Pharmaceutical Inspectorates Cooperation Organization Department of FSI «SID & GP» Ms. Madina Sottaeva presented the first results of cooperation of EAEU GMP-inspectorates and spoke about the approaches to documents elaboration.

At the end of the section, the audience addressed many questions about the rules of registration, documents presentation and assuring compliance as a result of inspections, as well as on other topics.