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Actual issues of law enforcement when creating uniform drug markets in the EAEU and the EU

10/29/2019 | EAEU, drug registration, pharmaceutical market

On October 22, 2019 in Moscow took place the International Scientific and Practical Conference “Harmonization of regulatory requirements in creating a single market for medicines - the experience of the EAEU and the EU. Opportunities, challenges, key enforcement issues. ” The event provided the market experts of the EAEU member countries with a unique opportunity to discuss with the leading world experts the current status of the development of the regulatory system within the EAEU and the EU, the benefits of convergence of regulatory standards and constant dialogue between regulators and the industry for the development of harmonized approaches at the supranational level.

The forum was organized by the Association of International Pharmaceutical Manufacturers (AIPM), the European Federation of the Pharmaceutical Industry and Associations (EFPIA) with the support of the Eurasian Economic Commission and the global Association of Healthcare Specialists in the Field of Drug Regulation “Drug Information Association” (DIA), which for the first time participated in an event for the EAEU member states.

The conference brought together more than 200 pharmaceutical industry professionals, including representatives of authorized regulatory bodies and expert organizations of the EAEU member states, the Eurasian Economic Commission, leading professional associations and industry. Significantly, more than 30 representatives of regulators from different countries contributed to the conference.

Presentations at the forum were made by the representatives of the Ministry of Health of the Russian Federation, the Republic of Belarus, the Kyrgyz Republic, specialized expert organizations from Russia, Kazakhstan, Armenia, the Ministry of Industry and Trade of Russia, the Eurasian Economic Commission, industry associations and industry, as well as world leading experts in the field of drug circulation regulation such as Dr. Petra Dorr, who has extensive experience with the Swiss Medicines Agency and the governing bodies of the International of Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Medical Use (ICH), Dr. Thomas Salmonson, more than 10 years headed the Committee for Evaluation of Medicinal Products for the medical use of the European Medicines Agency (CHMP / EMA).

The introduction of the Eurasian standards for regulating of drug circulation requires comprehensive professional interaction between the regulators of the Member States of the Union and the industry, based on trust and constant cooperation, the development and application of common regulatory and technical standards, and the development of new professional competencies.

Discussion around such fundamental issues as promoting global regulatory convergence, harmonizing regulatory requirements within the ICH, regulatory and enforcement challenges for regional legislation, developing and implementing an eCTD dossier format, rational use of resources of regulatory authorities and industry, developing IT platforms for the successful functioning of a single market, the concept of "regulatory confidence", the first experience in the examination and registration of medicines, inspection of products The rules of the Union and many others aroused widespread interest of the audience.

Opening the conference, AIPM Executive Director Vladimir Shipkov emphasized that this forum marks a new era in the relationship of Eurasian regulators with their European counterparts, national regulators of the EAEU member states and industry.

“From the very beginning of the creation of a single EAEU market, a fundamentally important decision was made - to take the best global regulatory practices that are developing and improving, primarily within the framework of the International Council for Harmonization (ICH) and the European Medicines Agency (EMA), as the basis for Eurasian regulation. Today, it can already be noted with confidence that the law of the Eurasian Union, on which we all worked together, gives the first practical results for business - the ability to apply for registration of medicines and conduct GMP-inspection of production in accordance with Eurasian requirements. In this regard, the opportunity to regularly discuss the practical implementation of the best regulatory approaches in various jurisdictions is a real contribution from the international industry, which can hardly be overestimated. ”

Kun Berden, Executive Director for International Affairs at EFPIA, in turn, also noted that the creation of common regulatory requirements within the EAEU is fully consistent with global regulatory trends.

“EFPIA is committed to global regulatory convergence. Everyone benefits from harmonization and regulatory cooperation processes. If you come together and start working together, raising standards, you will facilitate patient access to innovative medicines. All this represents a very important advantage for those countries that are included in this process. The Eurasian Union is showing tremendous progress in terms of creating a single market for medicines, and one of the important conditions for its further development is a fruitful dialogue that must constantly go on between regional regulators and other participants at the regional and international level. ”

Speaking at the plenary session, Deputy Director of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission, Dzhanyl Dzhusupova emphasized:

“The Eurasian Economic Commission, together with all parties, has done tremendous work. It is based on three systems that ensure the smooth functioning of the single market and the availability of medicines for the population of the countries of the Eurasian Union. This is, firstly, the regulatory system, which includes 47 regulations. Secondly, for the first time at the level of regional education, a unified codification system has been created, consisting of 34 directories and classifiers for medicines and medical devices, fully integrated into the international system for monitoring the safety of medicines. And, thirdly, a unified information system, which includes a register of medicines and related information databases. This allows for a transparent cross-border review of drug registration dossiers and is the basis for mutual recognition of the results of studies on the quality, safety and efficacy of drugs. ”

It is important that, for the first time, the basis for transparency of the registration process has become public expert reports posted in a single information system of the Eurasian Economic Union. In these reports, health administrators, doctors and patients will be able to familiarize themselves with the results of the evaluation of the drug, the evidence of its action, and the safety assessment put forward by the ministries of health of the Member States and expert organizations.

Yuri Olefir, Director General of the Federal Center for Healthcare and Health Care of the Russian Ministry of Health, spoke about the work in Russia in accepting applications for registration of medicines and bringing the dossier in line with the rules of the Eurasian Union, as well as the development of the functionality of information systems for filing an electronic dossier. He noted the need for an active systematic submission of documents for bringing into line with Eurasian requirements in order to complete all the necessary procedures by the end of the transition period, which will end on December 31, 2025. A message about the possibility of preliminary self-validation of the dossier in the electronic personal accounts of the applicants was greeted by applause from the audience. The Russian Federation leads in the number of applications, and, according to Yuri Olefir, the Russian Ministry of Health is expected to issue the first registration certificates within the framework of the EAEU requirements in the near future.

“For the first time at such a representative forum, the topic of“ regulatory trust ”was touched upon, that is, constructive cooperation of regulators from different countries, ”says the assistant professor of the organization of production and sale of medicines at the First Sechenov Moscow State Medical University Andrey Meshkovsky. - It seems that at present the need for such discussions is growing. As you know, the principles, rules and regulations of regulation of the EAEU common drug market are based on the experience of the European Union. Despite significant success in creating a regional control and permitting mechanism, there are some weak links in this process. As an example, the term “normative documentation” was used, used in the Russian Federation instead of the generally accepted term “specification”. The presence of such barriers at the terminology level in the EAEU documentation hinders the understanding and use of progressive international experience. ”

Representatives of the EEC and the authorized bodies of the countries of the Eurasian Economic Union members took an active part in discussing the currently achieved practical results in creating a unified market for the EAEU medicines, as well as identified issues requiring additional attention in the interests of the successful functioning of the market in the future. Conference participants noted that the transfer of the regulatory systems of the participating countries to a single EAEU platform, as well as its integration into the modern global regulatory agenda, is a necessary element in the further development of healthcare and drug provision systems in the Member States of the Eurasian Union.

During the first day of the conference, on October 22, the DIA, with the support of AIPM and EFPIA, organized a specialized workshop and a thematic session on the practical implementation of the electronic registration dossier format (eCTD) in various countries and the EAEU region, which were highly appreciated by the participants.

For AIPM, celebrating its 25th anniversary this year, the conference has become one of the most important international events dedicated to the anniversary.

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