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EAEU Pharmaceutical Market Integration

10/02/2019 | GMP certificate, EAEU

Years of work to create a single economic space of the Eurasian Economic Union have begun to pay off: pharmaceutical companies have begun to practice the use of regulatory tools that allow them to enter the markets of the EAEU countries with their products. What has already been done and what issues have yet to be resolved were discussed at the panel discussion “The Single Market of the EAEU Countries: Challenges and Prospects for Interaction” at the IV All-Russian GMP Conference.

The discussion was moderated by Elena Popova, Senior Director for Regulatory Affairs and Health Policy, Association of International Pharmaceutical Manufacturers (AIPM). Representatives of regulatory authorities and leading pharmaceutical companies from the EAEU countries discussed issues of harmonization of legislation.
From January 1, 2021, registration of drugs and inspection of their production will have to be carried out using EAEU GMP certificates, so today it is necessary to carry out work aimed at achieving this goal.

The speakers discussed issues such as regulating the sphere of circulation of drugs in the EAEU, harmonization of requirements and mutual recognition, the Pharmacopoeia of the EAEU and registration dossiers, especially the transition from national legislation to supranational.

The opinion was expressed by Dmitry Rozhdestvensky, Head of the Department for Coordination of Work in the Sphere of Medicinal Products and Medical Devices of the Department for Technical Regulation and Accreditation of the EEC, Director of the Department for State Regulation of the Circulation of Medicines of the Ministry of Health of the Russian Federation, Filipp Romanov, Director General of the Federal Center for Healthcare and Human Health, Ministry of Health of Russia, MD ., Yuri Olefir, and others.

Speakers from Belarus, Armenia, Kazakhstan and Kyrgyzstan took an important place in the discussion. Colleagues identified the difficult moments that they see for their part and shared their practical experience in registering drugs and inspecting production, harmonizing requirements and mutual recognition of the results of GMP inspection.

The first country that began to work according to the general procedures of the EAEU and today has already issued more than 10 certificates of GMP EAEU, is the Republic of Belarus. Today, all the member states of the Eurasian Economic Union have formed their GMP-inspectorate, almost all conduct checks on pharmaceutical production for compliance with good practices in accordance with national legislation. In each country, work is underway to harmonize national laws and bring local procedures to common EAEU rules.

Gelena Grosheva, Head of the Division for Licensing and Inspection of Drug Production of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, said that the Ministry is actively working to harmonize legislation. A draft law has been prepared that provides for the harmonization of the provisions of the legislation of the Russian Federation in the field of the circulation of medicines with regard to regulating the issues of inspection of pharmaceutical manufacturers for compliance with the EAEU GMP Rules, which are classified by the EAEU as the level of national legislation, and will be presented for discussion in the near future.

Participants in the discussion drew attention to the fact that training staff as future authorized representatives of pharmaceutical manufacturers is an important point. This topic was opened by Natalya Pyatigorskaya, Head of the Department of Industrial Pharmacy of the First Sechenov Moscow State Medical University, member of the SEC in the field of pharmacy, Doctor of Philosophy, professor. She noted that Sechenov University provides training for Authorized Persons, including training in accordance with the requirements of the EAEU. At the moment, on the scale of the market, it is necessary to develop a procedure that will provide for the provisions referred by the EAEU law to the level of national legislation, and will allow certification of authorized persons according to the rules of the EAEU.

Mkrtich Shakaryan, Head of the Good Pharmaceutical Practice Division of CJSC “Emil Gabrielyan Scientific Center for Drugs and Medical Technologies Expertise” CJSC, emphasized that harmonization of rules and uniform approaches to training inspectors in the field of quality is the main task today so that inconsistencies do not lead in the future to undermining trust and difficulties in the field of drug provision.

Representatives of the pharmaceutical industry also took part in the discussion. Speakers noted that in addition to the direct changes required by the creation of a single market, it is necessary to constantly improve the effectiveness of the quality system and improve pharmacovigilance.

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