‘RegLek-2018’ conference participants discussed issues in drug evaluation

| By | EAEU, GMP Inspectorate, Regulatory, SID&GP

On 19th November the scientific-practical conference ‘RegLek-2018’, was held in Moscow (Russia). Participants of the event discussed 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.

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 (FSI ‘SID&GP’) together with the Ministry of Industry and Trade of Russian federation 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. Vladislav Shestakov (Deputy Head of the Russian GMP-Inspectorate, Director of FSI ‘SID & GP’) emphasized this matter during the plenary session of the RegLek-2018 conference “Modern approaches to drugs expert evaluation”.

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.

Madina Sottaeva (Head of EAEU Pharmaceutical Inspectorates Cooperation Organization Department of FSI ‘SID & GP’) presented the first results of cooperation of EAEU GMP-inspectorates and spoke about the approaches to documents elaboration at the “Peculiarities of registration file compilation and submission according to the EAEU procedure: first experience” section of the conference.

SOURCE: sid&gp
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